Introduction

E2 (estradiol) is a form of estrogen, a female sex hormone produced by the ovaries. Estradiol has 2 hydroxyl groups in its molecular structure. This steroid hormone has a molecular weight of 272.4 daltons. E2 is secreted into the blood where 98% of it circulates bound to SHBG (sex hormone binding globulin). To a lesser extent it is bound to other serum proteins such as albumin.  E2 is responsible for the growth of the female uterus, fallopian tubes, and vagina. It promotes breast development and the growth of the outer genitals. The hormone plays a role in the distribution of body fat in women and stops the process of growing taller. In sexually mature females, it’s produced mainly by the ovaries and in smaller amounts by the adrenal glands. Estrogen is also produced by the placenta during pregnancy. Sexually mature males have much lower blood levels of E2, which are produced by the testes and adrenal glands. In non-pregnancy females with normal menstrual cycles, E2 secretion follows a cyclic, biphasic pattern with the highest concentration found immediately prior to ovulation. During pregnancy, maternal serum E2 levels increase considerably. In cases of infertility, serum E2 measurements are useful for monitoring induction of ovulation following treatment with, for example, clomiphene citrate, LH-RH (LH-releasing hormone), or exogenous gonadotropins.  E2 levels affect the functioning of the ovaries seriously. This can evaluate menstrual problems, including abnormal bleeding or missing periods. The E2 test may also be used in boys or girls to check the damage or disease of the testes, ovaries, or adrenal glands.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, mouse anti-rabbit antibodies coated microparticles, Antibody Solution and enzyme labeled E2 are combined. During the incubation, enzyme labeled E2 and E2 present in the sample compete for binding to the antibodies in Antibody Solution, then the reaction mixture bind to the mouse anti-rabbit antibodies coated on microparticles. After washing, a complex is generated between the solid phase, antibodies in Antibody Solution, E2 in the sample and enzyme-linked E2 by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of E2 in the sample.

Introduction

PRL (prolactin) is a protein that in humans is encoded by the PRL gene.In humans, prolactin is produced at least in the pituitary, decidua, myometrium, breast, lymphocytes, leukocytes and prostate.Prolactin levels may be checked as part of a sex hormone workup, as elevated PRL secretion can suppress the secretion of FSH and GnRH, leading to hypogonadism, and sometimes causing erectile dysfunction in men. Pregnant women have high levels of PRL, which helps make breast milk. During pregnancy, PRL levels increase by 10 to 20 times. Partial isolated PRL deficiency is rare, and case reports of total isolated PRL deficiency are rarer still and may have a genetic component. When a person has a prolactinoma, prolactin levels may be ordered periodically to monitor the progress of the tumor and its response to treatment. They may also be used at regular intervals to monitor for prolactinoma recurrence. A PRL test measures the level of the hormone PRL, which is made by the pituitary gland in the blood. PRL levels are different throughout the day. The highest levels occur during sleep and shortly after the human wake up, so the levels may be lower than normal.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-PRL coated microparticles and enzyme labeled anti-PRL are combined. PRL present in the sample is allowed to react simultaneously with the two antibodies, resulting in the PRL being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is generated between the solid phase, the PRL within the sample and enzyme-linked antibodies by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of PRL in the samples.

Introduction

Testosterone is a steroid hormone from the androgen group. In men, testosterone plays a key role in the development of male reproductive tissues such as the testis and prostate as well as promoting secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair. Generally, an adult human male body produces about ten times more testosterone than an adult human female body, but females are more sensitive to the hormone. In females, it is needed for hormonal balance and to help women’s bodies to function normally, if a woman’s body is producing too much testosterone, she may have more body hair than average, have abnormal or no menstrual periods, or be infertile. There are many factors that can affect the testosterone levels for an individual. Testosterone testing is used to diagnose several conditions in men, women, and boys. The conditions include testicular tumors in men; hypothalamus or pituitary disorders; hirsutism and virilization in girls and women. A number of methods for detecting testosterone use by athletes have been employed, most based on a urine test. In some testing programs, an individual’s own historical results may serve as a reference interval for interpretation of a suspicious finding. Another approach being investigated is the detection of the administered form of testosterone.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, goat polyclonal anti-mouse IgG antibodies coated microparticles, Antibody Solution and enzyme labeled testosterone are combined. During the incubation, enzyme labeled testosterone and testosterone present in the sample compete for binding to the antibodies in Antibody Solution, then the reaction mixture bind to the anti-mouse IgG antibodies coated on microparticles. After washing, a complex is generated between the solid phase, antibodies in Antibody Solution, testosterone in the sample and enzyme-linked testosterone by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of testosterone in the sample.

Introduction

LH (luteinizing hormone) is produced in both males and females from the anterior pituitary gland in response to LH-RH (luteinizing hormone-releasing hormone), which is released by the hypothalamus.In both males and females, LH is essential for reproduction. In females, at the time of menstruation, FSH (follicle-stimulating hormone) initiates follicular growth, specifically affecting granulosa cells. With the rise in oestrogens, LH receptors are also expressed on the maturing follicle that produces an increasing amount of estradiol. In males, LH acts upon the Leydig cells of the testis and is responsible for the production of testosterone, so the LH may be measured if testosterone levels are low. In males and females, LH (and FSH) tests are ordered as part of the workup of infertility, suspected pituitary problems, or gonadal disorders when a woman is having trouble getting pregnant or when pituitary, ovary, or gonadal disorders are suspected.  In males, LH is a glycoprotein with a molecular weight of approximately 30,000 daltons. It is composed of two dissimilar amino acid chains, alpha and beta. The alpha chain is similar to that found in human TSH (thyroid-stimulating hormone), FSH, and HCG (human chorionic gonadotropin). In females, after conception, the developing embryo produces HCG, which causes the corpus luteum to continue producing progesterone and estradiol. The corpus luteum regresses if pregnancy does not occur, and the corresponding drop in progesterone and estradiol levels results in menstruation.  A lack of secretion by the anterior pituitary may cause lower LH levels. As may be expected, low levels may result in infertility in both males and females. Low LH values may indicate some dysfunction of the pituitary or hypothalamus, while the actual source of the problem must be confirmed by other tests.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-LH coated microparticles and enzyme labeled anti-LH are combined. LH present in the sample is allowed to react simultaneously with the two antibodies, resulting in the LH being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is generated between the solid phase, the LH within the sample and enzyme-linked antibodies by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of LH in the samples.

Introduction

FSH (follicle-stimulating hormone) is a hormone found in humans and other animals. It is synthesized and secreted by gonadotrophs of the anterior pituitary gland.  A follicle-stimulating hormone test measures the amount of FSH in a blood sample. FSH is produced by the pituitary gland. FSH is a glycoprotein gonadotropin secreted by the anterior pituitary in response to GnRH (gonadotropin-releasing hormone), which is released by the hypothalamus. The same pituitary cell also secretes LH (luteinizing hormone). FSH and LH are composed of alpha and beta subunits. The specific beta subunit confers the unique biologic activity. FSH and LH bind to receptors in the testis and ovary and regulate gonadal function by promoting sex steroid production and gametogenesis. In women, FSH helps control the menstrual cycle and the production of ovums by the ovaries. The amount of FSH varies throughout a woman’s menstrual cycle and is highest just before she releases an ovum. In men, FSH helps control the production of sperm. The amount of FSH in men normally remains constant. It has been found that recombinant human FSH may affect some improvement by either providing sperm in ejaculate or increasing intracytoplasmic sperm injection success in infertile men with maturation arrest. In females and males, FSH and LH are ordered as part of the workup of infertility and pituitary or gonadal disorders. FSH may be ordered when a woman’s menstrual cycle has stopped or become irregular, to determine if the woman has entered menopause. In women, FSH and LH levels can help to differentiate between primary ovarian failure (failure of the ovaries themselves) and secondary ovarian failure (failure of the ovaries due to disorders of either the pituitary or the hypothalamus). Increased levels of FSH and LH are consistent with primary ovarian failure.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-FSH coated microparticles and enzyme labeled anti-FSH are combined. FSH present in the sample is allowed to react simultaneously with the two antibodies, resulting in the FSH being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is generated between the solid phase, the FSH within the sample and enzyme-linked antibodies by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of FSH in the samples.

Introduction

PRG (progesterone) is a steroid hormone whose main role is to help prepare a female’s body for pregnancy; it works in conjunction with several other female hormones. In mammals, progesterone, like all other steroid hormones, is synthesized from pregnenolone, which in turn is derived from cholesterol. Progesterone exerts its primary action through the intracellular progesterone receptor although a distinct, membrane bound progesterone receptor has also been postulated. In addition, progesterone is a highly potent antagonist of the mineralocorticoid receptor.  Abnormal progesterone secretion has been implicated in premenstrual tension, irregular shedding of endometrium, dysmenorrhoea, and luteal insufficiency.In females, progesterone levels are relatively low during the preovulatory phase of the menstrual cycle, rise after ovulation, and are elevated during the luteal phase. Progesterone levels are relatively low in children and postmenopausal women. Progesterone levels may be ordered, along with other tests such as an FSH, LH, HCG, thyroid tests and clotting tests, to help determine the cause of abnormal uterine bleeding in non-pregnant women. And this test measures the level of progesterone in the blood.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, mouse anti-sheep antibodies coated microparticles, Antibody Solution and enzyme labeled PRG are combined. During the incubation, enzyme labeled PRG and PRG present in the sample compete for binding to the antibodies in Antibody Solution, then the reaction mixture bind to the mouse anti-sheep antibodies coated on microparticles. After washing, a complex is generated between the solid phase, antibodies in Antibody Solution, PRG in the sample and enzyme-linked PRG by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of PRG in the sample.

Introduction

Human Chorionic Gonadotropin is a glycoprotein hormone produced by trophoblast during pregnancy, has a similar structure to the pituitary hormones FSH, TSH and LH. The α-subunit of hCG is identical with the α-subunit of LH, but the β-subunit is different and exhibits different immunity and biological activity . Determination of serum β-hCG can be used for early pregnancy diagnosis and pregnancy monitoring. Serum and urine concentrations of biologically active hCG rise exponentially in the first trimester of pregnancy, doubling every 48h, to a peak at about 10 weeks of gestation and then slowly decrease until the end of pregnancy. After the end of pregnancy, hCG concentration decrease back to <5 mIU / mL . In general, ectopic pregnancy and threatened abortion has a lower β-hCG levels or growth rate than normal pregnancy; multiple pregnancies have a higher β-hCG level than normal pregnancy. The monitoring of serum β-hCG levels contribute to threatened abortion, ectopic pregnancy diagnosis.   Measurement Principle

This assay is based upon the two-step sandwich method. In the first step, the sample and β-hCG antibody coated microparticles are combined. During the incubation, β-hCG present in the sample binds to the antibodies coated microparticles. After the washing, in the second step, enzyme conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the β-hCG within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of β-hCG in the patient sample.

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Introduction

C-reactive protein (CRP) is an annular (ring-shaped), pentameric protein found in blood plasma, whose levels rise in response to inflammation. It is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells. CRP is synthesized by the liver in response to factors released by macrophages and fat cells (adipocytes). It was named as such for its ability to bind and precipitate the C-polysaccharide of pneumococcus.  CRP is one of the acute-phase proteins, the serum or plasma levels of which rise during general, nonspecific response to a wide variety of diseases. CRP may also be found in patients with Guillain-Barre syndrome and multiple sclerosis, certain viral infections, tuberculosis, acute infectious hepatitis, many other necrotic and inflammatory diseases, burned patients and after surgical trauma. CRP levels rise in circulation within 24-48 hours following acute tissue damage, reach a peak (up to 1000 times the constitutive level) and decrease with the resolution of trauma or inflammation. The elevated levels of CRP may last for several days before reaching back to normal levels. Measurement of CRP by high sensitivity CRP assays adds to the predictive value of other cardiac markers like Myoglobin, CK-MB, cTnI and cTnT to assess the risk of cardiovascular and peripheral vascular disease. With the advent of sensitive methodologies, the use of high sensitivity CRP assays is becoming more routine to aid in the determination of inflammation due to cardiovascular trauma.

Measurement Principle 

This assay is based upon the two-step sandwich method. The sample and anti-CRP coated microparticles are combined in the first incubation. After addition of enzyme linked anti-CRP, CRP present in the sample is allowed to react simultaneously with the two antibodies, resulting in the CRP being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated among the microparticles, the CRP within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of CRP in the patient sample.

Introduction

Procalcitonin (PCT) is a precursor of the hormone calcitonin, which is involved with calcium homeostasis, and is produced by the C-cells of the thyroid gland. It is there that procalcitonin is cleaved into calcitonin, katacalcin and a protein residue. It is composed of 116 amino acids and is produced by parafollicular cells (C cells) of the thyroidand by the neuroendocrine cells of the lung and the intestine.The level of procalcitonin rises in a response to a proinflammatory stimulus, especially of bacterial origin. With the derangements that a severe infection with an associated systemic response brings, the blood levels of procalcitonin may rise.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-PCT coated microparticles and enzyme labeled anti-PCT are added to the reaction vessel. During incubation, PCT present in the sample is allowed to react simultaneously with the two antibodies, resulting in the PCT being sandwiched between the microparticles-coated antibodies and enzyme-labeled antibodies. After washing, a complex is generated among the solid phase, the PCT within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of PCT in the samples.

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Introduction

A cortisol test may be ordered to screen for and help diagnose Cushing syndrome, a group of signs and symptoms associated with excess cortisol. Blood cortisol testing evaluates both protein-bound and free cortisol while urine testing evaluates only free cortisol, which should correlate with the levels of free cortisol in the blood. Sometimes salivary cortisol is also ordered to help detect Cushing syndrome. Blood cortisol is also used to help diagnose adrenal insufficiency and Addison disease, conditions in which the adrenal glands do not function properly. Multiple blood and/or saliva cortisol levels collected at different times, such as at 8 am and 4 pm, can be used to evaluate both cortisol concentrations and diurnal variation. Normally, the level of cortisol in the blood rises and falls in a “diurnal variation” pattern, peaking early in the morning then declining throughout the day and reaching its lowest level about midnight. A 24-hour urine cortisol sample will not show diurnal variation; it will measure the total amount of unbound cortisol excreted in 24 hours.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, secondary antibody coated microparticles, enzyme labeled Cortisol and antibody solution are added. During the incubation, enzyme labeled antigen and Cortisol present in the sample compete for binding to the antibodies in antibody solution, then the compound binding to the secondary antibody coated on microparticles. After washing, a complex is generated among the solid phase, primary antibody, Cortisol in the sample or enzyme-linked antigen by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the concentration of Cortisol in the patient sample.

Introduction

Adrenocorticotropic Hormone (ACTH) is a polypeptide hormone which exists principally as a chain, 39 amino acids long, with a molecular mass of approximately 4,500 daltons. It is produced in the pituitary and serves to stimulate steroid production by the adrenal cortex. ACTH levels in the blood are measured to help detect, diagnose, and monitor conditions associated with excessive or deficient cortisol in the body. This test is ordered when someone has signs or symptoms associated with excess or deficient cortisol. Plasma levels of ACTH exhibit a significant diurnal variation. It is important, therefore, to standardize the time of collection: reference ranges have typically been established for approximately 9 in the morning.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and Anti-ACTH coated microparticles are added. During the incubation, ACTH present in the sample is bind to the antibodies that coat the microparticles, after washing, in the second step, ACTH antigens captured on the microparticles are allowed to react enzyme-linked antibodies. After the second washing, a complex is generated among the microparticles, the ACTH within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of ACTH in the patient sample.

Introduction

Aldosterone is a hormone that plays an important role in maintaining normal sodium and potassium concentrations in blood and in controlling blood volume and blood pressure. Aldosterone is produced by the adrenal glands located at the top of each kidney, in their outer portion (called the adrenal cortex). Aldosterone stimulates the retention of sodium (salt) and the excretion of potassium by the kidneys. Aldosterone is responsible for the reabsorption of about 2% of filtered sodium in the kidneys, which is nearly equal to the entire sodium content in human blood under normal glomerular filtration rates.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, Mouse anti-rabbit antibody coated microparticles, Antibody Solution and enzyme labeled aldosterone antigen are added. During the incubation, enzyme labeled aldosterone antigen and aldosterone present in the sample compete for binding to the antibodies which had been bind to microparticles. After washing, a complex is generated among the antibodies binding to microparticles, aldosterone in the sample or enzyme-linked antigen by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the concentration of aldosterone in the patient sample.

Introduction

Renin is a proteolytic enzyme which is secreted by the renal juxtaglomerular apparatus or cells of the kidney. Renin catalyzes the cleavage of a decapeptide, angiotensin I, from the circulating substrate, angiotensinogen. Angiotensin I is further converted to an octapeptide, angiotensin II, by the action of angiotensin-converting enzyme (ACE). Angiotensin II is a powerful vasoconstrictor which acting on the arterioles, it’s because angiotensin II has stronger biologicalactivity. Angiotensinogen and angiotensin-converting enzyme (ACE) usually exist in plasma. The release of renin is a key point to determine the concentration of angiotensin in plasma. The primary structure of renin precursor consists of 406 amino acids with a pre- and a pro-segment carrying 20 and 46 amino acids, respectively. Mature renin contains 340 amino acids and has a molecular weight of 37 kDa. The detection of active renin applies to: 1. Auxiliary diagnosis of hypertension (caused by renal-artery stenosis); 2. auxilliary diagnosis of hyperaldosteronism.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the patient sample and Microparticles Solution are added. After incubation, unbound components are washed off. Enzyme labeled Renin antibody conjugate is added. Renin present in the sample is allowed to react simultaneously with the two antibodies, thus a complex is generated among the solid phase, the renin within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of Renin in the patient sample.

Introduction

Angiotensin II is a hormone that plays an important role in maintaining normal sodium and potassium concentrations in blood and in controlling blood volume and blood pressure. Angiotensin II stimulates the retention of sodium (salt) and the excretion of potassium by the kidneys.Angiotensin II is responsible for the reabsorption of about 2% of filtered sodium in the kidneys, which is nearly equal to the entire sodium content in human blood under normal glomerular filtration rates.Angiotensin I is converted to angiotensin II (AII) through removal of two C-terminal residues by the enzyme angiotensin-converting enzyme (ACE), primarily through ACE within the lung (but also present in endothelial cells and kidney epithelial cells). ACE found in other tissues of the body has no physiological role (ACE has a high density in the lung, but activation here promotes no vasoconstriction, angiotensin II is below physiological levels of action). Angiotensin II acts as an endocrine, autocrine / paracrine, and intracrine hormone.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, microparticles solution, enzyme conjugate, and Biotin-Angiotensin II are added. During incubation, streptavidin-labeled HRP combined with biotin labeled Angiotensin II antigen, Angiotensin II in the samples and antigens in Biotin-Angiotensin II competed to bind antibodies in the Microparticles Solution. After the incubation, a complex is generated among the microparticles, Angiotensin II in the sample or biotin-labeled Angiotensin II by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the concentration of Angiotensin II in the patient sample.

Introduction

Osteocalcin, also known as bone gamma-carboxyglutamic acid containing protein, is a non-collagenous protein hormone found in bone and dentin which is dependent on vitamin K. In human, the osteocalcin is encoded by the BGLAP,  whose receptor is GPRC6A.  It contains 49 amino acids and has a molecular weight of approx. 5800 daltons. Osteocalcin is secreted solely by osteoblasts and though to play a role in the body’s metabolic regulation and is pro-osteocalcin, or bone-building, by nature. It is also implicated in bone mineralization and calcium ion homeostasis. Osteocalcin acts as a hormone in the body, causing β cell in the pancreas to release more insulin, and at the same time directing fat cells to release the hormone adiponectin, which increases sensitivity to insulin. Osteocalcin acts on leydig cells of the testis to stimulate testosterone biosynthesis and therefore affect male fertility.  As osteocalcin is produced by osteoblasts, it is often used as a marker for the bone formation process. It has been observed that higher serum osteocalcin levels are relatively well correlated with increases in bone mineral density (BMD) during treatment with anabolic bone formation drugs for osteoporosis, such as Teriparatide. In many studies, osteocalcin is used as a preliminary biomarker on the effectiveness of a given drug on bone formation.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-osteocalcin coated microparticles and enzyme labeled anti-osteocalcin are combined. During the incubation, osteocalcin present in the sample is allowed to react simultaneously with the two antibodies, resulting in the osteocalcin being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is generated among the solid phase, osteocalcin in the sample and enzyme-linked antibodies by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of osteocalcin in the sample.

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Introduction

Vitamin D is a group of fat-soluble steroid hormone precursor responsible for increasing intestinal absorption of calcium, magnesium, and phosphate, and multiple other biological effects, which is mainly produced in the skin by exposure to sunlight. Vitamin D from the skin synthesis is biologically inactive; hydroxylation in the liver and kidney is required for activation. In humans, the most important compounds in this group are vitamin D3 and vitamin D2, both of them can be ingested from the diet and from supplements. Only a few foods contain vitamin D. The major natural source of the vitamin is synthesis of vitamin D3 in the skin from cholesterol through a chemical reaction that is dependent on sun exposure. Vitamin D is transported to the liver in combination with a binding protein in the bloodstream, converted to 25-hydroxyvitamin D in the liver, and then converted to 1,25-hydroxyvitamin D in the kidney. This is an active ingredient in which vitamin D functions. The 1,25 hydroxy vitamin D content in the circulation is extremely low, with a half-life of only 4 h. This primary circulating form of vitamin D (25-OH) is biologically inactive with levels approximately1000-fold greater than the circulating1,25‑dihydroxy vitamin D. The half-life of circulating vitamin D (25-OH) is 3 weeks. Vitamin D can regulate the balance of calcium and phosphorus metabolism and bone formation, and is closely related to cardiovascular disease, autoimmune diseases, diabetes and hypertension etc.6

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, 25-OH Vitamin D antibody coated microparticles and enzyme labeled 25-OH Vitamin D derivant are combined. During the incubation, enzyme labeled 25-OH Vitamin D derivant and 25-OH Vitamin D antigen present in the sample compete for binding to the 25-OH Vitamin D antibody coated on microparticles. After washing, a complex is generated between the solid phase and enzyme-linked derivant by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of 25-OH Vitamin D in the samples.

Introduction

Coronaviruses are a large family of single-stranded RNA viruses that infect mammals and birds, causing respiratory infection. SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS coronavirus 2 or SARS-CoV-2), a virus closely related to the SARS virus, causes an infectious disease named COVID-19 (Coronavirus disease 2019). Those affected may develop a fever, dry cough, fatigue and shortness of breath.2 Cases can progress to pneumonia and multi-organ failure, particularly in the most vulnerable. The infection can also be diagnosed from a combination of symptoms, risk factors, and a chest CT scan showing features of pneumonia. The results of this test may vary by apparent disease periods by time after symptom onset.

This product is used for the qualitative detection of SARS-CoV-2 IgG antibodies in human serum or plasma samples in vitro. It is used as a supplementary indicator for nucleic acid detection of SARS-CoV-2. It cannot be used as the standard for the diagnosis and exclusion of pneumonitis caused by SARS-CoV-2.

Measurement Principle 

This assay is based upon the two-step indirect method. The sample, recombinant SARS-CoV-2 antigen coated microparticles and Sample Diluent are combined. SARS-CoV-2 IgG present in the sample binds to the SARS-CoV-2 antigen coated microparticles. After washing, Enzyme Conjugate is added. During the incubation, a complex is generated among the solid phase, the SARS-CoV-2 IgG within the sample and HRP-conjugated anti-human IgG by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of SARS-CoV-2 IgG in the samples.

Introduction

Coronaviruses are a large family of single-stranded RNA viruses that infect mammals and birds, causing respiratory infection. SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS coronavirus 2 or SARS-CoV-2), a virus closely related to the SARS virus, causes an infectious disease named COVID-19 (Coronavirus disease 2019). Those affected may develop a fever, dry cough, fatigue and shortness of breath. Cases can progress to pneumonia and multi-organ failure, particularly in the most vulnerable. The infection can also be diagnosed from a combination of symptoms, risk factors, and a chest CT scan showing features of pneumonia. The results of this test may vary by apparent disease periods by time after symptom onset.

This product is used for the qualitative detection of SARS-CoV-2 IgM antibodies in human serum or plasma samples in vitro. It is used as a supplementary indicator for nucleic acid detection of SARS-CoV-2. It cannot be used as the standard for the diagnosis and exclusion of pneumonitis caused by SARS-CoV-2.

Measurement Principle 

This assay is based upon the two-step capture method. In the first step, sample and mouse anti-human IgM coated microparticles are combined. During the incubation, the IgM antibodies in the sample bind to the anti-human IgM coated on the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the HPR-conjugated SARS-CoV-2 antigen in the Enzyme Conjugate is allowed to react with the SARS-CoV-2 IgM already bound to the solid phase in the first step. A complex is generated among the solid phase, antibodies in the sample and enzyme-linked antigens by immunological reactions. After a second washing, the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of SARS-CoV-2 IgM in the sample.

Introduction

Coronaviruses are a large family of single-stranded RNA viruses that infect mammals and birds, causing respiratory infection. SARS-CoV-2 is mainly composed of four structural proteins including nuclear protein (N), viral envelop (E), matrix protein (M) and spike protein (S). S protein is a trimer transmembrane glycoprotein, which is composed of S1 and S2 subunits. The receptor binding domain (RBD) on S1 is directly involved in the recognition of host receptors. Angiotensin converting enzyme-2 (ACE2) is the main specific receptor for virus invasion into host cells. It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells.

Upon infection with SARS-CoV-2, the host mounts an immune response against the virus, typically including production of specific antibodies against viral antigens. It is found that the antibodies against SARS-CoV-2 with strong neutralizing capacity, especially potent if directed against the RBD. Numerous vaccines for COVID-19 are in development, many of which focus on eliciting an immune response to the RBD.

This kit is intended as an aid to assess the adaptive humoral immune response to the SARS-CoV-2 S protein. This kit uses a recombinant protein representing the RBD of the S antigen to quantitative determine the high affinity antibodies against SARS-CoV-2.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, SARS-CoV-2 RBD antigen coated microparticles and HRP labeled SARS-CoV-2 antigen are combined. During the incubation, specified SARS-CoV-2 RBD antibodies present in the sample are allowed to react simultaneously with the two antigens, resulting in the RBD antibodies being sandwiched between the solid phase and enzyme-linked antigens. After washing, a complex is generated among the solid phase, RBD antibodies in the sample and enzyme-linked antigens by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of SARS-CoV-2 antibodies in the sample.

Introduction

Coronaviruses are a large family of single-stranded RNA viruses that infect mammals and birds, causing respiratory infection. SARS-CoV-2 is mainly composed of four structural proteins including nuclear protein (N), viral envelop (E), matrix protein (M) and spike protein (S). S protein is a trimer transmembrane glycoprotein, which is composed of S1 and S2 subunits. The receptor binding domain (RBD) on S1 is directly involved in the recognition of host receptors. Angiotensin converting enzyme-2 (ACE2) is the main specific receptor for virus invasion into host cells. It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells.

Infection with SARS-CoV-2 initiates an immune response, the body produces specific antibodies, including IgG and IgM, which can be detected in the blood several days after the initial infection. But not all antibodies can block cellular infiltration and replication of the SARS-CoV-2 virus. The antibodies that prevent virus infection and replication are named neutralizing antibodies. It is unknown how long it takes for producing of neutralizing antibodies, and if they are always produced after SARS-CoV-2 infection. Not all patients can produce neutralizing antibodies.

This kit is intended to specifically detect neutralizing antibodies.

Measurement Principle 

The specific binding of ACE2 and RBD protein can be blocked by SARS-CoV-2 neutralizing antibody. This assay is based upon the one-step competitive method. SARS-CoV-2 specific neutralizing antibodies in the sample bind to the HRP labeled RBD antigen, which block the combination of ACE2 coated on the Microparticles and the RBD antigen. The HRP labeled RBD antigen not neutralized by the SARS-CoV-2 specific neutralizing antibodies forms a complex with ACE2 on the Microparticles. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of SARS-CoV-2 neutralizing antibody in the samples. This test is similar to conventional Virus Neutralization Test (VNT)

Introduction

Coronaviruses are a large family of single-stranded RNA viruses that infect mammals and birds, causing respiratory infection. SARS-CoV-2 is mainly composed of four structural proteins including nuclear protein (N), viral envelop (E), matrix protein (M) and spike protein (S). S protein is a trimer transmembrane glycoprotein, which is composed of S1 and S2 subunits. The receptor binding domain (RBD) on S1 is directly involved in the recognition of host receptors. Angiotensin converting enzyme-2 (ACE2) is the main specific receptor for virus invasion into host cells. It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells.

Infection with SARS-CoV-2 initiates an immune response, the body produces specific antibodies, including IgG and IgM, which can be detected in the blood several days after the initial infection. But not all antibodies can block cellular infiltration and replication of the SARS-CoV-2 virus. The antibodies that prevent virus infection and replication are named neutralizing antibodies. It is unknown how long it takes for producing of neutralizing antibodies, and if they are always produced after SARS-CoV-2 infection. Not all patients can produce neutralizing antibodies.

This kit is intended to specifically detect neutralization antibodies (NAb).

Measurement Principle 

The specific interaction of ACE2 and RBD protein can be neutralized by SARS-CoV-2 neutralizing antibodies. This assay is based upon the one-step competitive method. SARS-CoV-2 specific neutralizing antibodies in the sample bind to the HRP labeled RBD antigen, which neutralize the combination of ACE2 coated on the Microparticles and the RBD antigen. The HRP labeled RBD antigen not neutralized by the SARS-CoV-2 specific neutralizing antibodies forms a complex with ACE2 on the microparticles. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of SARS-CoV-2 neutralizing antibody in the samples.

Introduction

Coronaviruses are a large family of single-stranded RNA viruses that infect mammals and birds, causing respiratory infection. SARS-CoV-2 is mainly composed of four structural proteins including nuclear protein (N), viral envelop (E), matrix protein (M) and spike protein (S). S protein is a trimer transmembrane glycoprotein, which is composed of S1 and S2 subunits. The receptor binding domain (RBD) on S1 is directly involved in the recognition of host receptors. Angiotensin converting enzyme-2 (ACE2) is the main specific receptor for virus invasion into host cells. It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells.

Infection with SARS-CoV-2 initiates an immune response, the body produces specific antibodies, including IgG and IgM, which can be detected in the blood several days after the initial infection. But not all antibodies can block cellular infiltration and replication of the SARS-CoV-2 virus. The antibodies that prevent virus infection and replication are named neutralizing antibodies. It is unknown how long it takes for producing of neutralizing antibodies, and if they are always produced after SARS-CoV-2 infection. Not all patients can produce neutralizing antibodies.

This kit is intended to specifically detect neutralization antibodies (NAb).

Measurement Principle 

The specific interaction of ACE2 and RBD protein can be neutralized by SARS-CoV-2 neutralizing antibodies. This assay is based upon the one-step competitive method. SARS-CoV-2 specific neutralizing antibodies in the sample bind to the HRP labeled RBD antigen, which neutralize the combination of ACE2 coated on the Microparticles and the RBD antigen. The HRP labeled RBD antigen not neutralized by the SARS-CoV-2 specific neutralizing antibodies forms a complex with ACE2 on the microparticles. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of SARS-CoV-2 neutralizing antibody in the samples.

Introduction

Dehydroepiandrosterone sulfate (DHEA-S), also known as prasterone sulfate, is a naturally occurring, endogenous androstane steroid and neurosteroid and the 3β-sulfate ester of dehydroepiandrosterone (DHEA). As the sodium salt, prasterone sodium sulfate, DHEA-S is used as a pharmaceutical drug in Japan in the treatment of insufficient cervical ripening and cervical dilation during childbirth.Dehydroepiandrosterone sulfate levels above 1890 micromol/L or 700-800 µg/dL are highly suggestive of adrenal dysfunction because DHEA-S is made exclusively by the adrenal glands. Presence of DHEA-S is therefore used to rule out ovarian or testicular origin of excess androgen.

Measurement Principle 

This assay is based upon the one-step competitive method. The secondary antibody coated microparticles and rabbit polyclonal antibody-linked antibody solution are added, antibodies are generated after they bind together, then DHEA-S present in the sample and DHEA-S antigen in the Enzyme Conjugate are added and complete to bind to the antibodies. After the washing, a complex is generated among the antibodies, the DHEA-S within the sample and enzyme-linked antigens by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is reversely proportional to the concentration of DHEA-S in the patient sample.

Introduction

Sex hormone-binding globulin (SHBG) is a glycoprotein that binds to the two sex hormones: androgen and estrogen. Other steroid hormones such as progesterone, cortisol, and other corticosteroids are bound by transcortin. SHBG is found in all vertebrates apart from birds. SHBG is produced mostly by the liver and is released into the bloodstream. Other sites that produce SHBG include the brain, uterus, testes, and placenta.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, Anti-SHBG coated microparticles and enzyme linked Anti-SHBG are combined. During the incubation, SHBG present in the sample is allowed to react simultaneously with the two antibodies, resulting in the SHBG being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated among the microparticles, the SHBG within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of SHBG in the patient sample.

Introduction

17α-Hydroxyprogesterone (17α-OHP), or hydroxyprogesterone (OHP) (INN, BAN), also known as 17α-hydroxypregn-4-ene-3,20-dione, is an endogenous progestogen steroid hormone related to progesterone. It is also a chemical intermediate in the biosynthesis of many other endogenous steroids, including androgens, estrogens, glucocorticoids, and mineralocorticoids, as well as neurosteroids. Measurements of levels of 17α-OHP are useful in the evaluation of patients with suspected congenital adrenal hyperplasia as the typical enzymes that are defective, namely 21-hydroxylase and 11β-hydroxylase, lead to a build-up of 17α-OHP. In contrast, the rare patient with 17α-hydroxylase deficiency will have very low or undetectable levels of 17α-OHP. 17α-OHP levels can also be used to measure contribution of progestational activity of the corpus luteum during pregnancy as progesterone but not 17α-OHP is also contributed by the placenta.

Measurement Principle 

This assay is based upon the one-step competitive method. The secondary antibody coated microparticles and rabbit polyclonal antibody-linked antibody solution are added, antibodies are generated after they bind together, then 17α-OHP present in the sample and 17α-OHP antigen in the Enzyme Conjugate are added and complete to bind to the antibodies. After the washing, a complex is generated among the antibodies, the 17α-OHP within the sample and enzyme-linked antigens by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is reversely proportional to the concentration of 17α-OHP in the patient sample.

Introduction

Anti-Müllerian hormone (AMH), also known as Müllerian-inhibiting hormone (MIH), is a dimeric glycoprotein with a molar mass of 140 kDa . It is related to inhibin and activin from the transforming growth factor beta superfamily, whose key roles are in growth differentiation and folliculogenesis . AMH is expressed by granulosa cells of the ovary during the reproductive years, and limits the formation of primary follicles by inhibiting excessive follicular recruitment by FSH. The rise during childhood and adolescence is likely reflective of different stages of follicle development . From 25 years of age AMH declines to undetectable levels at menopause . The determination of AMH is used for general fertility assessment, as a biomarker of polycystic ovary syndrome, and for the assessment of the ovarian reserve prior to undergoing IVF treatment in order to identify poor responders and therefore reduce cancellation rate as well as to identify excessive responders and therefore reduce the risk of hyper-stimulation; also to predict ovarian response in a sample from a women undergoing ovulation induction.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, AMH antibodies coated microparticles and enzyme labeled anti-AMH are combined. During the incubation, AMH present in the sample is allowed to react simultaneously with the two antibodies, resulting in AMH being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated among the microparticles, the AMH within the sample and enzyme-linked antibodies by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of AMH in the patient sample.

Introduction

Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus (HBV). Hepatitis B infection can be spread through contact with the blood, semen, vaginal fluids, or other body fluids of someone who already has hepatitis B infection. The HBV can be passed to an infant during childbirth if the mother is infected.It is a major global health problem and the most serious type of viral hepatitis. It can cause chronic liver disease and puts people at high risk of death from cirrhosis of the liver and liver cancer. It used to be widely believed that the HBV is completely cleared by antiviral antibodies and specific cytotoxic T lymphocytes (CTLs) during acute viral hepatitis. It has been demonstrated however that traces of HBV are often detectable in the blood for many years after clinical recovery from acute hepatitis, despite the presence of serum antibodies and HBV-specific CTLs, which can be present at acute stage levels.The global prevalence of HBV carriers varies greatly and countries can be defined as having a high, intermediate and low prevalence of HBV infection based on a prevalence of HBsAg carriers of ≥8%, 2%-7%, and <2% respectively.

Measurement Principle 

This assay uses a two-step sandwich method. In the first step, the sample is added to the anti-HBs-coated microparticles. During incubation, HBsAg present in the sample bind to the antibodies that coat the microparticles. After washing, in the second step, an anti-HBs antibody-enzyme conjugate is added. During this incubation step, HBsAg bound to the solid-phase are allowed to react with the enzyme-labelled antibodies, resulting in the HBsAg being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is therefore generated by immunological reactions among the solid-phase antibody, the HBsAg that were present in the sample and the antibody in the enzyme conjugate. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HBsAg in the sample.

Introduction

Hepatitis B is a potentially life-threatening liver infection caused by the HBV (hepatitis B virus). Hepatitis B infection can be spread through having contact with the blood, semen, vaginal fluids, and other body fluids of someone who already has a hepatitis B infection. The hepatitis B virus can be passed to an infant during childbirth if the mother is infected. It is a major global health problem and the most serious type of viral hepatitis. It can cause chronic liver disease and puts people at high risk of death from cirrhosis of the liver and liver cancer.Anti-HBs is the antibody produced in response to HBV surface antigen, its levels in the blood rise during the recovery phase. It is used to detect previous exposure to HBV; it can also be acquired from successful vaccination. HBsAg (hepatitis B surface antigen) and Anti-HBs and Anti-HBc (antibodies to both the surface and core antigens of the hepatitis B virus) have been studied in 64 consecutive cases of fulminant hepatitis.A reduced level of hepatitis B virus replication persists in most of the patients after HBeAg to Anti-HBe seroconversion and might be predictive of reactivation, and in contrast, hepatitis B virus replication progressively disappears in most of the patients after HBsAg to Anti-HBs seroconversion. This test is done to determine the need for vaccination (if Anti-HBs is absent) or to determine if a person has recovered from infections and is immune (cannot get the infection again).

Measurement Principle

This assay uses a one-step sandwich method. The sample and enzyme conjugate are added to the HBsAg-coated microparticles. During incubation, HBsAg antibodies present in the sample are allowed to react simultaneously with the two antigens, resulting in the HBsAg antibodies being sandwiched between the solid phase and enzyme-linked antigens. After washing, a complex is therefore generated by immunological reactions among the solid-phase antigens, the anti-HBs antibodies that were present in the sample and the antigen in the Enzyme Conjugate. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of anti-HBs in the sample.

Introduction

Chronic infection with the HBV (hepatitis B virus) is a major cause of chronic liver disease worldwide.The virus was first discovered as “Australia antigen”, later renamed HBsAg (for hepatitis B surface antigen), in patient blood. HBeAg (hepatitis B e antigen) was identified several years later as a marker for patients at high risk for transmission of the disease. It has been found that HBeAg, in addition to HBsAg, may be a useful marker of the risk of hepatocellular carcinoma. Persons considered to be at high risk because of positivity for HBeAg would be candidates for antiviral-drug treatment and close monitoring for the development of liver diseases associated with chronic HBV infection.  There are mainly 6 immunologic markers of HBV: HBeAg, HBcAg, HBsAg and their respective antibodies. HBeAg however is detected only in HBsAg positive sera. Its presence coincides with the rapid propagation of HBV and high infectivity. It is also a marker of questionable prognosis including the development of chronic hepatitis. On the contrary, Anti-HBe represents minimum viral replication and greatly reduced infectivity. When a patient changes from HBeAg to its antibody, he or she is likely to enter convalescent stage. But it is also possible that patients with Anti-HBe are long-term carriers of HBV. Nevertheless, patients with Anti-HBe generally have optimistic prognosis.

Measurement Principle

This assay uses a one-step sandwich method. The sample and enzyme conjugate are added to the anti-HBe-coated microparticles. During incubation, HBeAg present in the sample are allowed to react simultaneously with the two antibodies, resulting in the HBeAg being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is therefore generated by immunological reactions among the solid-phase antibody, the HBeAg that were present in the sample and the antibody in the enzyme conjugate. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HBeAg in the sample.

Coming soon…

Introduction

Hepatitis B core antigen (HBcAg) is a particle from the core of the hepatitis B virion (HCV), sometimes referred to as the Dane particle. The detection of antibody to hepatitis B core antigen (Anti-HBc) is used to monitor the progress of HBV infections. Anti-HBc is found in serum shortly after the appearance of hepatitis B surface antigen (HBsAg) and, in acute hepatitis B, will persist after the disappearance of HBsAg and before the appearance of detectable antibody to HBsAg (Anti-HBs). Accordingly, they are an indicator of existing or past hepatitis B infection.  Due to the long persistence of Anti-HBc following a hepatitis B viral infection, screening for Anti-HBc provides the best information on the prevalence of hepatitis B in a particular group of persons. During active infection both immunoglobulin M (IgM) and immunoglobulin G (IgG) anti-HBc are usually present. Therefore, in the absence of HBsAg and anti-HBs, Anti-HBc may be the only serological markers of HBV infection during the ‘window period’ when HBsAg has cleared but before antibodies to HBsAg are detectable.

Measurement Principle 

This assay uses a one-step competitive method. The sample, hepatitis B core antigen coated paramagnetic microparticles and HRP labeled Hepatitis B Core Antibody as enzyme conjugate are combined. During the incubation, HRP labeled Hepatitis B Core Antibody and Anti-HBc present in the sample compete for binding to hepatitis B core antigen coated microparticles. After washing, a complex is generated among the solid phase, Anti-HBc in the sample or enzyme-linked Anti-HBc by immunological reactions. After washing, the substrates are added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of Anti-HBc in the samples.

Introduction

IgM antibody to HBc (IgM anti-HBc) rise rapidly in patients with acute infection and persists for several weeks to months. High anti-HBc IgM titers can be found in acute HBV infection and in attacks during chronic hepatitis B. The level of anti-HBc IgM decreases throughout the course of infection. Anti-HBc IgM may also be present in patients with chronic hepatitis B viral infection. The concentrations are generally lower than those associated with acute infections and may rise and fall with exacerbation of the disease. Anti-HBc IgM can aid to distinguish acute hepatitis illness due to HBV versus superimposed infections by other possible agents such as hepatitis A, hepatitis C, or delta virus.

Measurement Principle 

This assay is based upon the two-step capture method. In the first step, sample and mouse monoclonal anti-human IgM coated microparticles are combined. During the incubation, the antibodies present in the sample bind to the anti-human IgM coated on the microparticles. After the washing, in the second step, Hepatitis B Core antigen solution and HRP labeled Hepatitis B Core antibody as Enzyme Conjugate are added to the reaction mixture. During the incubation, a complex is generated among the solid phase, anti-HBc IgM in the sample, HBcAg solution and enzyme-linked anti-HBc by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of anti-HBc IgM in the samples.

Coming soon…

Introduction

The identification of Treponema pallidum antibodies aids in the diagnosis of syphilis caused by the microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis. Treponema pallidum is a chronic bacterial infection that remains a public health concern worldwide. The WHO estimated that 12 million new cases of venereal syphilis occurred in 1999, more than 90% of them in developing countries, with a rapidly increasing number of cases in Eastern Europe .  Syphilis can be transmitted congenitally or by sexual contact. Congenital syphilis is of particular concern in developing nations as it may lead to spontaneous abortion, stillbirth, death of the neonate, or disease in the infant; a recent report from Tanzania estimates that up to 50% of stillbirths are caused by syphilis. Of particular importance to worldwide health is the recognition that syphilis infection greatly increases the transmission and acquisition of human immunodeficiency virus (HIV) . These factors, along with the highly destructive nature of late disease, make syphilis an important public health concern. The disease can evolve into a latent phase in which syphilis is clinically inapparent.  The serological detection of specific antibodies to T. pallidumis of particular importance in the diagnosis of syphilis, as the natural course of the infection is characterized by periods without clinical manifestations. Serological tests are divided into nontreponemal and treponemal tests and neither alone is sufficient for diagnosis, in addition to patients’ clinical history, are currently the primary methods for the diagnosis and management of syphilis. Nontreponemal tests can be used to monitor therapy, but owing to their low specificity the positive results obtained by these methods need to be confirmed by treponemal tests. As the positivity at treponemal tests lasts throughout the life, treponemal tests cannot be used in the follow-up of patients. Consequently, the quest for simple, reliable, and money-saving diagnostic methods continues.  This assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis.

Measurement Principle 

This assay is based upon the principle of the one step sandwich technique for the qualitative detection of the various antibodies associated with Treponema pallidum (TP) in human serum or plasma, using chemiluminescent microparticle immunoassay (CLIA Micropaticles) technology. The sample, TP antigen coated paramagnetic microparticles and HRP labeled TP antigen as enzyme conjugate are combined. During the incubation, a complex is generated among the solid phase, the Anti-TP within the sample and enzyme-labeled antigen by immunological reactions. After washing, the substrates are added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of Anti-TP in the samples.

Introduction

The identification of Treponema pallidum antibodies aids in the diagnosis of syphilis caused by the microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis. Treponema pallidum is a chronic bacterial infection that remains a public health concern worldwide. The WHO estimated that 12 million new cases of venereal syphilis occurred in 1999, more than 90% of them in developing countries, with a rapidly increasing number of cases in Eastern Europe .  Syphilis can be transmitted congenitally or by sexual contact. Congenital syphilis is of particular concern in developing nations as it may lead to spontaneous abortion, stillbirth, death of the neonate, or disease in the infant; a recent report from Tanzania estimates that up to 50% of stillbirths are caused by syphilis. Of particular importance to worldwide health is the recognition that syphilis infection greatly increases the transmission and acquisition of human immunodeficiency virus (HIV) . These factors, along with the highly destructive nature of late disease, make syphilis an important public health concern. The disease can evolve into a latent phase in which syphilis is clinically inapparent.  The serological detection of specific antibodies to T. pallidumis of particular importance in the diagnosis of syphilis, as the natural course of the infection is characterized by periods without clinical manifestations. Serological tests are divided into nontreponemal and treponemal tests and neither alone is sufficient for diagnosis, in addition to patients’ clinical history, are currently the primary methods for the diagnosis and management of syphilis. Nontreponemal tests can be used to monitor therapy, but owing to their low specificity the positive results obtained by these methods need to be confirmed by treponemal tests. As the positivity at treponemal tests lasts throughout the life, treponemal tests cannot be used in the follow-up of patients. Consequently, the quest for simple, reliable, and money-saving diagnostic methods continues.  This assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis.

Measurement Principle 

This assay is based upon the principle of the one step sandwich technique for the qualitative detection of the various antibodies associated with Treponema pallidum (TP) in human serum or plasma, using chemiluminescent microparticle immunoassay (CLIA Micropaticles) technology. The sample, TP antigen coated paramagnetic microparticles and HRP labeled TP antigen as enzyme conjugate are combined. During the incubation, a complex is generated among the solid phase, the Anti-TP within the sample and enzyme-labeled antigen by immunological reactions. After washing, the substrates are added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of Anti-TP in the samples.

Introduction

Two types of human immunodeficiency virus, HIV-1 and HIV-2, have been described and implicated as causative of the Acquired Immunodeficiency Syndrome (AIDS). Both are retroviruses which are transmitted by sexual contact, exposure to blood or blood products, and prenatal or perinatal infection of a fetus or newborn3. Antibodies against HIV are neatly always detected in AIDS patients and HIV-infected asymptomatic individuals. HIV has several major genes coding for structural proteins that are found in all retroviruses as well as several nonstructural genes unique to HIV. The HIV genome contains three major genes, 5’gag-pol-env-3′, encoding major structural proteins as well as essential enzymes. These are synthesized as polyproteins which produce proteins for virion interior, called Gag, group specific antigen; the viral enzymes (Pol, polymerase) or the glycoproteins of the virion env (envelope) .  Knowledge on genetic variability of the HIV virus strains were acquired by sequencing the GAG, POL, and ENV genes of the representative strains of each subtype. The HIV-2 virus includes 5 sub-types. Some HIV-1 variants have only 70% homology for the GAG and POL genes with the main isolates and only 50% for the ENV gene, these differences can explain the failure of the infection diagnosis in some patients. HIV/AIDS pandemic is a complex mix of diverse epidemics within and between countries and regions of the world, and is undoubtedly the defining public-health crisis of our time. As of 2012, approximately 35.3 million people are living with HIV globally. Of these, approximately 17.2 million are men, 16.8 million are women and 3.4 million are less than 15 years old8. There were about 1.8 million deaths from AIDS in 2010, down from 2.2 million in 20058. The Anti-HIV CLIA Microparticles assay is a chemiluminescent microparticle immunoassay (CMIA) for the simultaneous qualitative detection of human immunodeficiency virus (HIV) antibodies to HIV type 1 (HIV-1 Group M) and/or type 2 (HIV-2) in human serum and plasma (EDTA, heparin or sodium citrate). This assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection.

Measurement Principle 

This assay is based upon the two-step sandwich method. The sample, HIV-1/HIV-2 antigen coated microparticles and Sample Diluent are combined. HIV-1/HIV-2 antibodies present in the sample binds to HIV-1/HIV-2 antigen coated microparticles. After washing, Enzyme Conjugate is added. During the incubation, a complex is generated among the solid phase, the Anti-HIV within the sample and enzyme-labeled antigen by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of Anti-HIV in the samples.

Coming soon…

Coming soon…

Coming soon…

Introduction

Two types of human immunodeficiency virus, HIV-1 and HIV-2, have been described and implicated as causative of the Acquired Immunodeficiency Syndrome (AIDS) . Both are retroviruses which are transmitted by sexual contact, exposure to blood or blood products, and prenatal or perinatal infection of a fetus or newborn. Antibodies against HIV are neatly always detected in AIDS patients and HIV-infected asymptomatic individuals. HIV has several major genes coding for structural proteins that are found in all retroviruses as well as several nonstructural genes unique to HIV. The HIV genome contains three major genes, 5′ gag pol env -3′, encoding major structural proteins as well as essential enzymes. These are synthesized as polyproteins which produce proteins for virion interior, called Gag, group specific antigen; the viral enzymes (Pol, polymerase) or the glycoproteins of the virion Env (envelope) .  Knowledge on genetic variability of the HIV virus strains were acquired by sequencing the gag , pol , and env genes of the representative strains of each subtype. The HIV-2 virus includes 5 sub-types. Some HIV-1 variants have only 70% homology for the gag and pol genes with the main isolates and only 50% for the env gene, these differences can explain the failure of the infection diagnosis in some patients. HIV/AIDS pandemic is a complex mix of diverse epidemics within and between countries and regions of the world, and is undoubtedly the defining public-health crisis of our time. As of 2012, approximately 35.3 million people are living with HIV globally. Of these, approximately 17.2 million are men, 16.8 million are women and 3.4 million are less than 15 years old8. There were about 1.8 million deaths from AIDS in 2010, down from 2.2 million in 20058. The HIV structural protein most often used as the marker of antigenemia is the core protein, p24. p24 antigen tests are used for early detection of HIV, as p24 antigen rises soon after infection relative to antibodies, and the test is often used in combination with an antibody test to effectively cover a longer portion of the window period.

Measurement Principle 

This assay is based upon the principle of the two-step sandwich technique for the qualitative detection of the various antibodies to HIV-1 (Group M and Group O) /HIV-2 virus and p24 antigen in human serum or plasma, using chemiluminescent microparticle immunoassay technology. In the first step, sample, microparticles solution and biotin labeled p24 antibody solution are added. HIV-1/HIV-2 antibodies present in the sample bind to the HIV-1/HIV-2 antigen coated microparticles, HIV p24 antigen present in the sample bind to the HIV p24 antibody coated microparticles and biotin labeled p24 antibody. After washing, enzyme conjugate is added. During the incubation, a complex is generated either among antigen coated microparticles, the Anti-HIV within the sample and enzyme-labeled antigen or antibody coated microparticles, p24 antigen in the sample, biotin p24 antibody and HRP labeled streptavidin by immunological reactions. After washing, the substrates are added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HIV antibody/antigen in the samples.

Introduction

CK-MB is a cardiac marker used to assist diagnoses of an acute myocardial infarction. It is one of the three tissue isoforms (with CK-BB and CK-MM) of creatine kinase (CK). CK-MB is made up of two sub-units (MW= 40,000 each): M sub-unit, expressed in muscle, and B sub-unit, expressed in brain. CK-MM and CK-MB are distributed primarily in the skeletal muscle and heart muscle, respectively, while CK-BB is present mainly in the brain and in tissues composed of smooth muscle. Following myocardial infarction the CK-MB level rises and reaches a peak between 18-24hrs, the increase being similar to that of the total CK activity.  After an acute myocardial infarction (AMI), CK-MB appears in the circulation and CK-MB activity increases significantly, reflecting damage to the myocardium. This elevation is highly specific for the laboratory diagnosis of myocardial infarction.  Measurements of CK-MB can also aid in the non-invasive assessment of the efficacy of myocardial reperfusion following thrombolytic therapy.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-CK-MB coated microparticles and enzyme labeled anti-CK-MB are added to the reaction vessel. During incubation, CK-MB present in the sample is allowed to react simultaneously with the two antibodies, resulting in the CK-MB being sandwiched between the microparticles-coated antibodies and enzyme-labeled antibodies. After washing, a complex is generated among the solid phase, the CK-MB within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of CK-MB in the samples.

Introduction

Cardiac troponin I (cTnI) is a contractile protein exclusively present in the cardiac muscle. It is one of three subunits of the troponin complex (I, T, C), which with tropomyosin are bound to actin in the thin filament of the myofibril. Its physiological role is to inhibit the ATPase activity of the actin-myosin complex in the absence of calcium, and therefore, to prevent muscular contraction. The content of cardiac troponin in normal serum is much lower than other cardiac enzymes, and the concentration in cardiac muscle cells is very high. cTnI levels in acute myocardial infarction (AMI) exhibit similar rise and fall patterns to those found in CK-MB. The collection of at least three blood samples during the early triage period has been recommended. cTnI is 13 times more abundant in the myocardium than CK-MB and does not normally circulate in the blood, so the signal to noise ratio is more favorable for the detection of myocardial necrosis.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, cTnI antibody coated microparticles and enzyme-labeled anti-cTnI are added to the reaction vessel. During incubation, cTnI present in the sample is allowed to react simultaneously with the two antibodies, resulting in the cTnI being sandwiched between the microparticles-coated antibodies and enzyme-labeled antibodies. After washing, a complex is generated among the solid phase, the cTnI within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of cTnI in the samples.

Introduction

Myoglobin is a tightly folded, globular heme-protein located in the cytoplasm of both skeletal and cardiac muscle cells. And it is an iron- and oxygen-binding protein found in the muscle tissue of vertebrates in general and in almost all mammals. It is related to hemoglobin, which is the iron- and oxygen-binding protein in blood, specifically in the red blood cells. In humans, myoglobin is only found in the bloodstream after muscle injury. Myoglobin is the primary oxygen-carrying pigment of muscle tissues. The molecular weight of myoglobin is approximately 17,800 daltons. The relatively low molecular weight and the location of storage accounts for the rapid release from damaged muscle cells and earlier rises in concentration measured above baseline in blood as compared to other cardiac markers. Myoglobin is released from damaged muscle tissue (rhabdomyolysis), which has very high concentrations of myoglobin. The released myoglobin is filtered by the kidneys but is toxic to the renal tubular epithelium and so may cause acute renal failure.  Myoglobin is a sensitive marker for muscle injury, making it a potential marker for heart attack in patients with chest pain. However, elevated myoglobin has low specificity for acute myocardial infarction (AMI) and thus CK-MB, cTnT, ECG, and clinical signs should be taken into account to make the diagnosis. Since myoglobin is present in both cardiac and skeletal muscle, any damage to either of these muscle types results in its release into the blood stream. Serum levels of myoglobin have been shown to elevate under the following conditions: skeletal muscle damage, skeletal muscle or neuromuscular disorders, cardiac bypass surgery, renal failure, strenuous exercise, etc. Therefore, the utilization of an increase in serum myoglobin has to be used in conjunction with other aspects of the patient assessment in order to aid in the diagnosis of an AMI. Myoglobin may also rise moderately above the reference range in chronic ischemic heart disease .

Measurement Principle 

This assay is based upon the one-step sandwich method. The diluted sample, MYO antibody coated microparticles and enzyme labeled anti-MYO are added to the reaction vessel. During incubation, MYO present in the sample is allowed to react simultaneously with the two antibodies, resulting in the MYO being sandwiched between the microparticles-coated antibodies and enzyme-labeled antibodies. After washing, a complex is generated among the solid phase, the MYO within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of MYO in the samples.

Introduction

Clinical information and imaging procedures are used to diagnose left ventricular dysfunction.The significance of natriuretic peptides in the control of cardiovascular system function has been demonstrated. Initial studies reveal that natriuretic peptides can be used for diagnostic clinical problems associated with left ventricular dysfunction. The following natriuretic peptides have been described: atrial natriuretic peptide (ANP), B-type natriuretic peptide (BNP), and C-type natriuretic peptide (CNP). In subjects with left ventricular dysfunction, serum and plasma concentrations of BNP increase, as does the concentration of the putatively inactive amino-terminal fragment, NT-proBNP. ProBNP, comprising 108 amino acids, is secreted mainly by the ventricle and, in this process, is cleaved into physiologically active BNP (77-108) and the N-terminal fragment NT-proBNP (1-76).Studies indicate that NT-proBNP can be used in diagnostic and prognostic applications. The concentration of NT-proBNP in serum or plasma correlates with the prognosis of the left ventricular dysfunction.

Measurement Principle 

This assay is based upon the two-step sandwich method. The sample and NT-proBNP antibody coated microparticles are combined in the first incubation. After addition of enzyme linked with NT-proBNP antibody, NT-proBNP present in the sample is allowed to react simultaneously with the two antibodies, resulting in the NT-proBNP being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated among the microparticles, the NT-proBNP within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of NT-proBNP in the patient sample.

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Introduction

Ferritin is a ubiquitous intracellular protein that stores iron and releases it in a controlled fashion. In humans, it acts as a buffer against iron deficiency and iron overload . It is found in most tissues as a cytosolic protein, but small amounts are secreted into the serum where it functions as an iron carrier. Plasma ferritin is also an indirect marker of the total amount of iron stored in the body .  Ferritin serves to store iron in a non-toxic form, to deposit it in a safe form, and to transport it to areas where it is required . Serum ferritin measurements are clinically significant in the monitoring of the iron status of pregnant women, blood donors, and renal dialysis patients. High ferritin levels may indicate iron overload without apparent liver damage, as may be noted in the early stages of idiopathic hemochromatosis. Ferritin levels in serum have also been used to evaluate clinical conditions not related to iron storage, including inflammation, chronic liver disease, and malignancy.

Measurement Principle 

This assay is based upon one-step sandwich method. The sample, ferritin antibody coated microparticles and enzyme labeled ferritin antibody are combined. Ferritin present in the sample is allowed to react simultaneously with the two antibodies, resulting in the ferritin being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated among the microparticles, the ferritin within the sample and enzyme-linked antibody by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of ferritin in the sample.

Introduction

Folate, which is known as folic acid, folacin and vitamin B9, is one of the B vitamins. Folate in the form of folic acid is used to treat anemia caused by folic acid deficiency.Folate is necessary for the production and maintenance of new cells, for DNA synthesis and RNA synthesis through methylation, and for preventing changes to DNA, and, thus, for preventing cancer. As humans cannot make folic acid, it is required from the diet, making it an essential vitamin. Folate occurs in a wide variety of foods, including vegetables (particularly dark green leaf vegetables), fruits and fruit juices, nuts, soybeans, chickpeas, dairy products, poultry and meat, eggs, seafood, grains, and some beers.Folic acid is also used as a supplement by women during pregnancy to prevent neural tube defects (NTD) in the baby. The United States Preventive Services Task Force recommends the folic acid supplementation for all women able to become pregnant.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, folate antigen coated microparticles, enzyme labeled folate binding protein (FBP) are combined. The sample was pretreated with Pre-treatment Reagent A, Pre-treatment Reagent B, and Pre-treatment Reagent C to release the folate in the sample. During the incubation, the folate present in the sample and folate antigen coated in the microparticles compete for binding to the enzyme labeled FBP. After washing, a complex is generated between the solid phase and enzyme-linked FBP by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of folate in the sample.

Introduction

Vitamin B12, also called cobalamin, is a water-soluble vitamin that is involved in the metabolism of every cell of the human body. Vitamin B12 has the largest and most complex chemical structure of all the vitamins. Vitamin B12 or cobalamin plays essential roles in folate metabolism and in the synthesis of the citric acid cycle intermediate, succinyl-CoA.Vitamin B12 deficiency is commonly associated with chronic stomach inflammation, which may contribute to an autoimmune vitamin B12 malabsorption syndrome called pernicious anemia and to a food-bound vitamin B12 malabsorption syndrome. Impairment of vitamin B12 absorption can cause megaloblastic anmia and neurologic disorders in deficient subjects. Other causes of vitamin B12 deficiency include surgical resection of the stomach or portions of the small intestine where receptors for the IF-B12 complex are located.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, intrinsic factor antibody coated microparticles, enzyme labeled intrinsic factor antibody are combined. The sample was pretreated with Pre-treatment Reagent A, Pre-treatment Reagent B, and Pre-treatment Reagent C to release the vitamin B12 in the sample. During the incubation, the vitamin B12 present in the sample and intrinsic factor antibody coated in the microparticles compete for binding to the Intrinsic Factor, a complex is generated between the solid phase, Intrinsic Factor and enzyme-linked intrinsic factor antibody by immunological reactions. After washing, the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of vitamin B12 in the sample.

Introduction

Insulin-like growth factor 1 (IGF-1), also called somatomedin C, is a protein that in humans is encoded by the IGF 1 gene . IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges. IGF-1 has a molecular weight of 7,649 daltons . It plays an important role in childhood growth and continues to have anabolic effects in adults.  IGF-1 is along with growth hormone (GH) , helps promote normal bone and tissue growth and development. IGF-1 mirrors growth hormone excesses and deficiencies, but the level in the blood is stable throughout the day, making it a useful indicator of average growth hormone levels . A synthetic analog of IGF-1, mecasermin, is used for the treatment of growth failure . Plasma IGF-I levels are barely detectable at birth, rise gradually during childhood, peak during mid-puberty until approximately 40 years of age, then decline gradually .  Decreased levels of IGF-1 may be seen with a GH deficiency or insensitivity to GH. If this is in a child, the GH deficiency may have already caused short stature and delayed development and may be treated with GH supplementation. Adults will have an age-related decrease in production, but lower than expected levels may reflect a GH deficiency or insensitivity . Elevated levels of IGF-1 usually indicate an increased production of GH. Since GH levels vary throughout the day, IGF-1 levels are a reflection of average GH production, not of the actual amount of GH in the blood at the time that the sample for the IGF-1 measurement was taken. This is accurate up to the point at which the liver’s capacity to produce IGF-1 is reached. With severely increased GH production, the IGF-1 level will stabilize at an elevated maximum level. Increased levels of GH and IGF-1 are normal during puberty and pregnancy but otherwise are most frequently due to pituitary tumors (usually benign) .

Measurement Principle 

This assay is based upon the one-step sandwich method. The diluted sample, anti-IGF-1 coated microparticles and enzyme labeled anti-IGF-1 are added to the reaction vessel. During incubation, IGF-1 present in the sample, the microparticles-coated antibodies and enzyme-labeled antibodies are combined together. After washing, a sandwiched complex is generated among the solid phase, the IGF-1 within the sample, enzyme-linked antibodies and microparticles-coated antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of IGF-1 in the samples.

Introduction

Human Growth Hormone (HGH) is a peptide hormone that stimulates growth, cell reproduction and regeneration in humans and other animals. Growth hormone is a single-chain polypeptide that is synthesized, stored, and secreted by somatotropin cells within the lateral wings of the anterior pituitary gland. Human Growth Hormone is a stress hormonethat raises the concentration of glucose and free fatty acids. It also stimulates production of IGF-1. The major isoform of the human growth hormone is a protein of 191amino acids and a molecular weight of 22,124 daltons. Effects of HGH on the tissues of the body can generally be described as anabolic (building up). Like most other protein hormones, HGH acts by interacting with a specific receptor on the surface of cells. Increased height during childhood is the most widely known effect of growth hormone.  Excessive secretion of hormones in kids is a reason for increase in their height. As age increases, the secretion reduces and this directly results in certain body related issues. The medicines increases energy, reduces body fat, makes heart resistant to diseases, bones becomes stronger, rejuvenates skin, improves memory, develops immune system further and there are many more benefits of HGH. Growth hormone is essential for children to grow normally. The role of the growth hormone in adults is to maintaining the necessary levels of body fat, muscle and bone. Inadequate or no growth hormone in adults leads to emotional problems like tiredness and lack of motivation, and sometimes affects cholesterol level as well.Deficiency in growth hormone occurs due to inadequate or absence of secretion of growth hormone. The conditions responsible for this may either be congenital which occurs from birth or acquired which results after birth. The cause of congenital growth hormone deficiency could be due to an abnormal pituitary gland or another syndrome altogether.

Measurement Principle

This assay is based upon the one-step sandwich method. The sample, anti-HGH coated microparticles and enzyme labeled anti-HGH are added to the reaction vessel. During incubation, HGH present in the sample is allowed to react simultaneously with the two antibodies, resulting in the HGH being sandwiched between the microparticles-coated antibodies and enzyme-labeled antibodies. After washing, a complex is generated among the solid phase, the HGH within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HGH in the samples.

Introduction

The pancreas is located behind the lower part of the stomach. It makes insulin and enzymes that help the body digest and use food. Throughout the pancreas are clusters of cells called the islets of Langerhans. Islets are made up of several types of cells, including beta cells that make insulin. Insulin is a hormone that helps the body use glucose for energy. Human insulin is a peptide hormone composed of 51 amino acids and has a molecular weight of 5808 daltons. Insulin levels are most frequently ordered following a low glucose and/or when someone has acute or chronic symptoms of low blood sugar (hypoglycemia), Insulin and C-peptide are produced by the body at the same rate as part of the conversion of proinsulin to insulin in the pancreas. Both may be ordered to evaluate how much insulin in the blood is made by the body (endogenous) and how much is from exogenous sources. The test for insulin measures insulin from both sources while the C-peptide test reflects insulin produced by the pancreas (endogenous insulin). Insulin concentrations tend to be higher in obese individuals, particularly those with an increased proportion of visceral (abdominal) fat. Measurement of circulating insulin concentrations may be useful in the diagnostic evaluation of several conditions. High circulating insulin concentrations may be involved in the pathogenesis of hypertension and cardiovascular disease. Conversely, low insulin concentrations in the presence of hyperglycemia suggest insulin-deficiency, e.g. insulin-dependent or Type 1 diabetes mellitus. Measurement of immediate or first-phase insulin secretion after an acute glucose load may be predictive of Type 1 diabetes mellitus.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, Insulin antibodies coated microparticles and enzyme-labeled Insulin antibodies are combined. During the incubation, Insulin present in the sample is allowed to react simultaneously with the two antibodies, resulting in the Insulin being sandwiched between the coated microparticles and enzyme-linked antibodies. After washing, a complex is generated among the coated microparticles-antibodies, the Insulin within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of Insulin in the patient sample

Introduction

Diabetes mellitus is a disease where your body does not produce enough insulin, or else the insulin it produces is not doing what it is supposed to do, which is to lower blood sugar. As a result, your blood sugar levels increase causing hyperglycemia. It has several types. The common types are Type 1 diabetes formerly known as insulin-dependent and Type 2 diabetes formerly named non-insulin-dependent.   C-peptide is a biologically active peptide. Clinical studies show that C-peptide administration in type 1 diabetes patients, who lack the peptide, results in amelioration of diabetes-induced renal and nerve dysfunction. Short-term administration of physiological amounts of C-peptide to patients with insulin-dependent diabetes was found to reduce the glomerular hyperfiltration in these patients as well as augment the whole body glucose utilization.   C-peptide has been shown to bind to the surface of a number of cell types such as neuronal, endothelial, fibroblast and renal tubular, at nanomolar concentrations to a receptor that is likely G-protein-coupled. C-Peptide has a longer circulating half-life than insulin and undergoes relatively minimal hepatic metabolism. In addition, C-Peptide of insulin assays may be analytically more sensitive than insulin assays. Because of these factors, measurements of C-Peptide of insulin may be useful in evaluating insulin secretion in a variety of clinical conditions.  Today, C-peptide continues to serve as a special diagnostic tool in diabetology and related fields.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, C-Peptide antibodies coated microparticles and enzyme-labeled C-Peptide antibodies are combined. During the incubation, C-Peptides present in the sample are allowed to react simultaneously with the two antibodies, resulting in the C-Peptides being sandwiched between the coated microparticles and enzyme-linked antibodies. After washing, a complex is generated among the coated–microparticles-antibodies, the C-Peptides within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of C-Peptide in the patient sample.

Introduction

Tuberculosis is a chronic infectious disease caused by the Mycobacterium tuberculosis complex. It is mainly transmitted through the air to the body’s multiple organ system, especially the lung accounting for various organs. It can also affect organs such as liver, kidney, brain and lymph nodes.  Tuberculosis patients often have fever, night sweats, fatigue, weight loss, loss of appetite, and cough blood. One third of the world’s people currently have M. tuberculosis infection. And about 10% of them will develop into active tuberculosis.

In recent years, interferon gamma release assay (IGRA) has been developed. The ELISA and ELISPOT (ELISA or ELISPOT) method adopts for the quantitative detection of IFN-γ level in whole blood and peripheral blood monocytes under the specific stimulation of tuberculosis antigens and was an aid in the diagnosis of tuberculosis.

Measurement Principle 

This assay is based upon one-step sandwich method. Firstly, the supernatant collected after the incubation, Microparticles Solution, Enzyme labeled IFN-γ antibody conjugate are added. IFN-γ present in the supernatant collected after the incubation is allowed to react simultaneously with the two antibodies, thus a complex is generated by immunological reactions. Chemiluminescent Substrate are then added and catalyzed by this complex, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLUs is proportional to the concentration of IFN-γ in the patient sample.

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Introduction

TSH (thyroid stimulating hormone) is a peptide hormone synthesized and secreted by thyrotrope cells in the anterior pituitary gland, which regulates the endocrine function of the thyroid gland. The determination of serum or plasma levels of TSH is recognized as a sensitive method in the diagnosis of primary and secondary hypothyroidism. TSH is secreted by the anterior lobe of the pituitary gland and induces the production and release of T4 (thyroxine) and T3 (triiodothyronine) from the thyroid gland.Although the concentration of TSH in the blood is extremely low, it is essential for the maintenance of normal thyroid function. The release of TSH is regulated by TRH (TSH-releasing hormone) produced by the hypothalamus. The levels of TSH and TRH are inversely related to the level of thyroid hormone. When there is a high level of thyroid hormone in the blood, less TRH is released by the hypothalamus, so less TSH is secreted by the pituitary. The opposite action will occur when there is decreased thyroid hormone in the blood. This process is known as a negative feedback mechanism and responsible for maintaining the proper blood levels of this hormones. TSH and the pituitary glycoproteins, LH (luteinizing hormone), FSH (follicle-stimulating hormone), and HCG (human chorionic gonadotropin), have identical alpha chains. The beta chains are distinct but do contain regions with identical amino acid sequences. These regions of homology can cause considerable cross-reactivity with some polyclonal TSH antibodies. The use of monoclonal antibodies in this TSH test eliminates this interference, which could result in falsely elevated TSH values in either menopausal or pregnant females, a population whose evaluation of thyroid status is clinically significant.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-TSH coated microparticles and enzyme labeled anti-TSH are combined. During the incubation, TSH present in the sample is allowed to react simultaneously with the two antibodies, resulting in the TSH being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is generated between the solid phase, the TSH within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of TSH in the samples.

Introduction

The human thyroid gland is a major component of the endocrine system. Thyroid hormones perform many important functions. They exert powerful and essential regulatory influences on growth, differentiation, cellular metabolism and general hormonal balance of the body, as well as on the maintenance of metabolic activities and the development of the skeletal and organ system.  The hormones T4 (thyroxine) and T3 (3, 5, 3’-triiodothyronine) circulate in the bloodstream, mostly bound to the plasma protein, TBG (thyroxine binding globulin) . The concentration of T3 is much less than that of T4, but its metabolic potency is much greater. T3 determination is an important factor in the diagnosis of thyroid diseases. Its measurement has uncovered a variant of hyperthyroidism in thyrotoxic patients with elevated T3 levels and normal T4 levels. An increase in T3 without an increase in T4 is frequently a forerunner of recurrent thyrotoxicosis in previously treated patients. The clinical significance of T3 is also evident in patients in whom euthyroidism is attributable only to normal T3, although their T4 values are subnormal. T3 determination is also useful in monitoring both patients under treatment for hyperthyroidism and patients who have discontinued anti-thyroid drug therapy. It is especially valuable in distinguishing between euthyroid and hyperthyroid subjects. In addition to hyperthyroidism, T3 levels are elevated in women who are pregnant, and in women receiving oral contraceptives or estrogen treatment, paralleling TBG increases in a manner analogous to T4 levels. Likewise, a reduction in TBG concentration decreases T3 concentration. These changes in the T3 level, however, are not a true reflection of thyroid status.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, T3 derivant coated microparticles and enzyme labeled anti-T3 are combined. During the incubation, T3 derivant coated on microparticles and T3 present in the sample compete for binding to the enzyme labeled antibodies. After washing, a complex is generated between the solid phase and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of T3 in the samples.

Introduction

T4 (thyroxine or 3, 5, 3’, 5’-tetraiodo-L-thyronine) is the major hormone produced by the thyroid gland. It has a molecular weight of 777 daltons and is synthesized by iodination of tyrosine residues on thyroglobulin. Proteolytic cleavage of follicular thyroglobulin releases T4 into the bloodstream. Greater than 99% of T4 is reversibly bound to three plasma proteins in the blood, TBG (thyroxine binding globulin) binds 70%, TBPA (thyroxine binding pre-albumin) binds 20%, and albumin binds 10%. Approximately 0.03% of T4 is in the free, unbound state in blood at any time. Diseases effecting thyroid function may present a wide array of confusing symptoms. Measurement of total T4 by immunoassay is the most reliable and convenient screening test available to determine the presence of thyroid disorders in patients. Increased levels of T4 have been found in hyper-thyroidism due to Grave’s disease and Plummer’s disease and in acute and subacute thyroiditis. Low levels of T4 have been associated with congenital hypothyroidism, myxedema, chronic thyroiditis (Hashimoto’s disease), and with some genetic abnormalities.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, anti-T4 coated microparticles and enzyme labeled T4 are combined. During the incubation, T4 labeled on Enzyme Conjugate and T4 present in the sample compete for binding to antibodies coated on microparticles. After washing, a complex is generated between the solid phase and enzyme-linked antigens by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of T4 in the samples.

Introduction

FT3 (free triiodothyronine) is the physiologically active form of the T3. Despite FT3 levels are not the most accurate indicator of thyroid function, and have limited applicability, but the determination of FT3 has the advantage of being independent of changes in the concentrations and binding properties of the binding proteins. FT3 measurements, like FT4 (free thyroxine), measure the hormone that is not bound to binding proteins such as TBG. Free hormone measurements are difficult since concentrations measured are very small – in fact the measurements actually estimate the free levels rather than measuring them directly. Compared with FT4 and TSH (thyrotropin), FT3 concentration is not frequently determined. First its concentration remains normal until hypothyroidism is severe, and FT3 is restricted to particular diagnosis where hyperthyroidism needs to be confirmed, finally, determinations of FT3 are frequently restricted to specialized departments.T3 (triiodothyronine) circulates in blood almost completely bound (>99.5%) to carrier proteins. Further, the concentrations of the carrier proteins are altered in many clinical conditions, such as pregnancy. For clinical studies of protein effects, FT3 is independent of serum protein concentration for TBG and TBPA binding proteins. In normal thyroid function, as the concentrations of the carrier proteins alter, the total T3 level changes so that the FT3 concentration remains constant. Thus, measurements of FT3 concentrations correlate more reliably with clinical status than total T3 levels. For example, the increase in total T3 levels associated with pregnancy, oral contraceptives and estrogen therapy result in higher total T3 levels while the FT3 concentration remains basically unchanged. In addition, it has been found that the mean FT3 value has a gradient decreasing from young to older.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, T3 derivant coated microparticles and enzyme labeled anti-T3 are combined. During the incubation, T3 derivant coated on microparticles and FT3 present in the sample compete for binding to the enzyme labeled antibodies. After washing, a complex is generated between the solid phase and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of FT3 in the samples.

Introduction

FT4 (free thyroxine) is an indicator of thyroxine activity in the body. It can also be measured as total thyroxine, which also depends on the thyroxine that is bound to TBG (thyroxine-binding globulin).Under normal thyroid condition, as the concentrations of the carrier proteins alter, the total T4 level changes but the FT4 concentration remains constant. Thus, measurement of FT4 concentrations correlates better with clinical status than total T4 levels. FT4 immunoassays depend upon serum protein-bound T4 dissociation to stabilize the FT4 concentration during assay perturbations, interassay differences in perturbations combined with variation in serum protein-bound T4 concentrations could produce discordant FT4 measurements.For example, the increase in total T4 associated with pregnancy, oral contraceptives and estrogen therapy occasionally result in total T4 levels over the limits of normal while the FT4 concentration remains within the normal reference range. Masking of abnormal thyroid function can also occur in both hyper and hypothyroid conditions by alterations in the TBG concentration.  The total T4 can be elevated or lowered by TBG changes such that the normal reference levels result is observed. Again, the FT4 concentration typically uncovers the patient’s actual clinical status. Neither FT4 immunoassay accurately reflects established free T4 changes during pregnancy. TT4 and the FT4 retained an appropriate inverse relationship with TSH throughout pregnancy and appear to provide a more reliable free T4 estimate.

Measurement Principle 

This assay is based upon the one-step competitive method. The sample, T4 derivant coated microparticles and enzyme labeled anti-T4 are combined. During the incubation, T4 derivant coated on microparticles and FT4 present in the sample compete for binding to the enzyme labeled antibodies. After washing, a complex is generated between the solid phase and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is inversely proportional to the amount of FT4 in the samples.

Introduction

TG (thyroglobulin) is a dimeric protein produced by and used entirely within the thyroid gland, and it is used by the thyroid gland to produce the T4 (thyroxine) and T3 (triiodothyronine). Measurements of TG antibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.. Antibodies to thyroglobulin have been shown to be characteristically present in patients with thyroiditis and primary thyrotoxicosis.This has led to the clinical measurement becoming a valuable tool in the diagnosis of thyroid dysfunction. PHA (Passive Hemaglutination) methods have been employed in the past for measurements of antibodies to TG. However, PHA tests do not have the sensitivity of enzyme immunoassay and are limited by subjective interpretation. This product, with the enhanced sensitivity of chemiluminescence immunoassay, permits the detection of subclinical levels of antibodies to TG. In addition, the results are quantitated by a luminometer, which eliminates subjective interpretation.

Measurement Principle 

This assay is based upon the two-step indirect method. In the first step, the diluted sample and the TG coated microparticles are combined. During the incubation, the anti-TG present in the sample binds to the antigen coated on the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the anti-TG present in the reaction mixture reacts with enzyme labeled anti-human IgG. Then a complex is generated between the solid phase and enzyme-linked anti-human IgG by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of anti-TG in the samples.

Introduction

TPO is an enzyme expressed mainly in the thyroid that liberates iodine for addition onto tyrosine residues on thyroglobulin for the production of T4 (thyroxine) or T3 (triiodothyronine), thyroid hormones. In humans, thyroperoxidase is encoded by the TPO gene. Antibodies to thyroid peroxidase have been shown to be characteristically present from patients with Hashimoto thyroiditis (95%), idiopathic myedema (90%) and Graves’ Disease (80%).In fact 72% of patients positive for anti-TPO exhibit some degree of thyroid dysfunction. This has led to the clinical measurement becoming a valuable tool in the diagnosis of thyroid dysfunction. Measurements of antibodies to TPO have been done, in the past, by PHA (Passive Hemaglutination). However, PHA tests do not have the sensitivity of enzyme immunoassay and are limited by subjective interpretation. This product, with the enhanced sensitivity of chemiluminescence immunoassay, permits the detection of subclinical levels of antibodies to TPO. In addition, the results are quantitated by a luminometer, which eliminates subjective interpretation. The assay of serum anti-TPO by chemiluminescence immunoassy is useful in the differential diagnosis of autoimmune thyroid disease.

Measurement Principle 

This assay is based upon the two-step indirect method. In the first step, the diluted sample and the TPO coated microparticles are combined. During the incubation, the anti-TPO present in the sample binds to the antigen coated on the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the anti-TPO present in the reaction mixture reacts with enzyme labeled anti-human IgG. Then a complex is generated between the solid phase and enzyme-linked anti-human IgG by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of anti-TPO in the samples.

Introduction

Parathyroid hormone (PTH), para-thormone or parathyrin, is secreted by the chief cells of the parathyroid glands as a polypeptide containing 84 amino acids. It acts to increase the concentration of calcium in the blood, whereas calcitonin (a hormone produced by the para-follicular cells (C cells) of the thyroid gland) acts to decrease calcium concentration. PTH acts to increase the concentration of calcium in the blood by acting upon the parathyroid hormone 1 receptor (high levels in bone and kidney).PTH half-life is approximately 4 minutes. It has a molecular mass of 9.4 kDa. Hyperparathyroidism, the presence of excessive amounts of parathyroid hormone in the blood, occurs in two very distinct sets of circumstances. Primary hyperparathyroidism is due to autonomous, abnormal hyper-secretion of PTH from the parathyroid gland, while secondary hyperparathyroidism is an appropriately high PTH level seen as a physiological response to hypocalcaemia. A low level of PTH in the blood is known as hypo-parathyroidism and is most commonly due to damage to or removal of parathyroid glands during thyroid surgery. In osteoporotic women, administration of an exogenous parathyroid hormone analogue (teriparatide, by daily injection) superimposed on estrogen therapy produced increases in bone mass and reduced vertebral and non-vertebral fractures by 45 to 65%.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-PTH coated microparticles and enzyme labeled anti-PTH are combined. During the incubation, PTH present in the sample is allowed to react simultaneously with the two antibodies, resulting in PTH being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated among the microparticles, the PTH within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of PTH in the patient sample.

Introduction

TG (thyroglobulin) is a dimeric protein with a molecular weight of approximately 660 kDa; it is used by the thyroid gland to produce the T4 (thyroxine) and T3 (triiodothyronine), each TG molecule forms approximately 10 thyroid hormone molecules. Elevated TG concentrations have been reported in different thyroid conditions such as thyroid adenoma and thyroid carcinoma. The determination of TG can also be helpful to distinguish between sub-acute thyroiditis and factitious thyrotoxicosis. TG testing is mainly for the post‑operative follow‑up of patients with differentiated thyroid carcinoma (DTC). As the TG is entirely produced by thyroid gland, the serum TG level will drop to a very low or undetectable concentration after total or near‑total thyroidectomy and successful radioiodine ablation of the residual thyroid tissue. Detectable levels of serum TG after total thyroidectomy are indicative of persistent or recurrent DTC. In consequence significantly increasing TG levels are interpreted as a sign of recurrence of the disease.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-TG coated microparticles and enzyme labeled anti-TG are combined. During the incubation, TG present in the sample is allowed to react simultaneously with the two antibodies, resulting in the TG being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is generated between the solid phase, the TG within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of TG in the samples.

Introduction

CMV (cytomegalovirus) is a species of virus that belongs to the viral family known as Herpesviridae. It causes severe and fatal diseases in immune-compromised individuals, including organ transplant recipients and individuals with AIDS. It is also a leading cause of virus-associated birth defects and is associated with atherosclerosis and coronary restenosis.  Most healthy people who are infected by CMV after birth have no symptoms.Some develop a syndrome similar to infectious mononucleosis or glandular fever, with prolonged fever, and a mild hepatitis. Most infections with CMV are not diagnosed because the virus usually produces few, if any, symptoms and tends to reactivate intermittently without symptoms. IgM antibodies are the first to be produced by the body in response to a CMV infection. They are present in most individuals within a week or two after the initial exposure. IgM antibody production rises for a short time period and then declines. After several months, the level of CMV IgM antibody usually falls below detectable levels. Additional IgM antibodies are produced when latent CMV is reactivated.

Measurement Principle

This assay is based upon the two-step capture method. In the first step, sample and mouse monoclonal anti-human IgM coated microparticles are combined. During the incubation, the antibodies present in the sample bind to the anti-human IgM coated on the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the HPR-conjugated CMV antigen in the Enzyme Conjugate is allowed to react with the CMV IgM already bound to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, antibodies in the sample and enzyme-linked antigens by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of CMV IgM in the sample.

Introduction

HSV (Herpes simplex virus) is an enveloped, DNA-containing virus morphologically similar to the other members of the Herpetoviridae family. HSV-1 and HSV-2 (Herpes simplex virus 1 and 2), also known as HHV-1 and -2 (Human herpes virus 1 and 2), are two members of the herpes virus family, Herpesviridae, that infect humans.Active virus excretion in genital secretions of pregnant women may result in severe neonatal HSV infection contracted when the infant passes through an infected genital tract. When HSV lesions are present during delivery, 40% to 60% of the neonates can be affected. Transmission of HSV infection to neonates is associated with high morbidity and mortality rates if untreated.The first humoral immune response to infection is the synthesis of specific anti-HSV IgM antibody which becomes detectable one week after infection. Normally this is a proof of recent or recurrent infection. Detection of IgG allows assessment of the patient’s immune status and provides serological evidence of prior exposure to HSV. This may aid in the diagnosis of recent (primary or recurrent) HSV infection in paired sera by the presence of seroconversion to HSV-1 or HSV-2 antibody.

Measurement Principle

This assay is based upon the two-step capture method. In the first step, sample and mouse monoclonal anti-human IgM coated microparticles are combined. During the incubation, the antibodies present in the sample bind to the anti-human IgM coated on the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the HSV-1 antigen in the Enzyme Conjugate is allowed to react with the HSV-1 IgM already bound to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, antibodies in the sample and enzyme-linked antigens by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HSV-1 IgM in the sample.

Introduction

HSV (Herpes simplex virus) is an enveloped, DNA-containing virus morphologically similar to the other members of the Herpetoviridae family. HSV-1 and HSV-2 (Herpes simplex virus 1 and 2), also known as HHV-1 and -2 (Human herpes virus 1 and 2), are two members of the herpes virus family, Herpesviridae, that infect humans.  Active virus excretion in genital secretions of pregnant women may result in severe neonatal HSV infection contracted when the infant passes through an infected genital tract. When HSV lesions are present during delivery, 40% to 60% of the neonates can be affected. Transmission of HSV infection to neonates is associated with high morbidity and mortality rates if untreated. The first humoral immune response to infection is the synthesis of specific anti-HSV IgM antibody which becomes detectable one week after infection. Normally this is a proof of recent or recurrent infection. Detection of IgG allows assessment of the patient’s immune status and provides serological evidence of prior exposure to HSV. This may aid in the diagnosis of recent (primary or recurrent) HSV infection in paired sera by the presence of seroconversion to HSV-1 or HSV-2 antibody.

Measurement Principle

This assay is based upon the two-step capture method. In the first step, sample and mouse monoclonal anti-human IgM coated microparticles are combined. During the incubation, the antibodies present in the sample bind to the anti-human IgM coated on the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the HSV-2 antigen in the Enzyme Conjugate is allowed to react with the HSV-2 IgM already bound to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, antibodies in the sample and enzyme-linked antigens by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HSV-2 IgM in the sample.

Introduction

Rubella is a disease caused by the Rubella virus, and has a single-stranded RNA genome. It is caused by a virus that is spread through the air or by close contact. The illness follows a typically benign clinical course with rare complications and is subclinical in a large proportion of cases. Symptomatology is generally mild, characterized by fever, malaise, a maculopapular rash of three to five days duration and, possibly, coryza and conjunctivitis. The disease is usually accompanied by lymphadenopathy. Infection confers lifelong immunity. Infection from Rubella virus is particularly disastrous if contracted during the first four months of gestation.If not immunologically protected, women infected during pregnancy run a high risk of embryo-foetal damage. Congenital Rubella causes a wide range of severe defects, many of which are permanent and adversely affect later development (cataract, deafness, hepatosplenomegaly, psychomotor retardation, bone alterations, cardiopathies, neuropathies).Rubella infection of children and adults is usually mild, self-limiting and often asymptomatic. The prognosis in children born with congenital Rubella syndrome is poor. The detection of Rubella-specific IgM antibodies is used as an aid in the diagnosis of acute Rubella infection. The ELISA method for Rubella antibody is most common and is the test done to see if a woman who is pregnant or planning to get pregnant is immune to Rubella.

Measurement Principle 

This assay is based upon the two-step capture method. In the first step, sample and mouse monoclonal anti-human IgM coated microparticles are incubated. During the incubation, the antibodies present in the sample bind to the anti-human IgM coated on the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the HRP-conjugated Rubella antigen in the Enzyme Conjugate is allowed to react with the Rubella IgM already bound to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, antibodies in the sample and enzyme-linked antigens by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of Rubella IgM in the sample.

Introduction

Toxoplasmosis is a quite widespread infectious disease caused by an intracellular protozoan parasite, called Toxoplasma gondii.The disease, affecting both man and warm blooded animals, can be transmitted by ingestion of food infected;direct contagion from domestic animals; or transplacental infection. In the normal adult population, toxoplasmosis has a generally benign course, being largely asymptomatic; sometimes mildly symptomatic (headache, sore throat, asthenia); or in rare cases accompanied by lymphadenitis. Exceptionally, severer disorders may be present, like myocarditis, hepatitis, pneumonia, meningoencephalitis and retinochoroiditis. The prevalence of positive serological tests increases with age, indicating past exposure. If the infection occurs in pregnant women, toxoplasmosis can cause a threat to the fetus with possible spontaneous abortion, prematurity or stillbirth, as the pathogen can be transmitted to the fetus via the placenta. The fetus whose mother is exposed to Toxoplasma infection during the first trimester of pregnancy develops severe lesions to the central nervous system that generally lead to fetal demise. Toxoplasma infection acquired during the second trimester may cause hydrocephalus, mental and psychomotor retardation, blindness and cerebral calcifications. Toxoplasma infection, however, is commonest during the third trimester, causing retinochoroiditis and other ocular lesions, lesions to the central nervous system and latent asymptomatic infection which may eventually develop into full-blown disease. Specific IgM antibodies to Toxoplasma develop two to four weeks after the onset of clinical signs and gradually decline thereafter, disappearing in three to nine months. Therefore, the presence of IgM and IgA in the absence of IgG or in the presence of low IgG levels is a strong evidence of acute toxoplasmosis. The differential diagnosis of acute toxoplasmosis made possible by the specific IgM assay allows adequate treatment which reduces the risks of the disease both in immune-compromised patients and in pregnant women. Specific IgG antibodies to Toxoplasma rise gradually and peak two to five months after the onset of clinical signs. Therefore, the presence of IgG is useful in distinguishing subjects having acquired the disease from those who have not. This is particularly important in order to adopt suitable prophylaxis in susceptible women of child-bearing age.

Measurement Principle 

This assay is based upon the two-step capture method. In the first step, sample and mouse monoclonal anti-human IgM coated microparticles are combined. During the incubation, the IgM antibodies present in the sample are captured by the anti-human IgM coated on the microparticles. After washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the Toxo antigen in the Enzyme Conjugate is allowed to react with the Toxo IgM already bound to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, antibodies in the sample and enzyme-linked antigens by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of Toxo IgM in the sample.

Introduction 

HSV (Herpes simplex virus) is an enveloped, DNA-containing virus morphologically similar to the other members of the Herpetoviridae family. HSV-1 and HSV-2 (Herpes simplex virus 1 and 2), also known as HHV-1 and -2 (Human herpes virus 1 and 2), are two members of the herpes virus family, Herpesviridae, that infect humans.  Active virus excretion in genital secretions of pregnant women may result in severe neonatal HSV infection contracted when the infant passes through an infected genital tract. When HSV lesions are present during delivery, 40% to 60% of the neonates can be affected. Transmission of HSV infection to neonates is associated with high morbidity and mortality rates if untreated. The first humoral immune response to infection is the synthesis of specific anti-HSV IgM antibody which becomes detectable one week after infection. Normally this is a proof of recent or recurrent infection. Detection of IgG allows assessment of the patient’s immune status and provides serological evidence of prior exposure to HSV. This may aid in the diagnosis of recent (primary or recurrent) HSV infection in paired sera by the presence of seroconversion to HSV-1 or HSV-2 antibody. Since HSV-1 and HSV-2 share common antigenic determinants, antibody directed against one viral type may cross react with the other viral type. Truly type-specific antibody tests are based on glycoprotein G1 (from HSV-1) and glycoprotein G2 (from HSV-2), as these proteins exhibit very limited homology. The CDC recommends the use of type-specific glycoprotein G based assays when serology is performed.

Measurement Principle

This assay is based upon the two-step indirect method. In the first step, sample and recombinant HSV-1 antigens coated microparticles are combined. During the incubation, the antibodies present in the sample bind to the HSV-1 antigens coated on the microparticles. After washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the mouse anti-human IgG in the Enzyme Conjugate is allowed to react with the antibodies already bound to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, antibodies in the sample and enzyme-linked mouse anti-human IgG by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HSV-1 IgG in the sample.

Introduction

HSV (Herpes simplex virus) is an enveloped, DNA-containing virus morphologically similar to the other members of the Herpesviridae family. HSV-1 and HSV-2 (Herpes simplex virus 1 and 2), also known as HHV-1 and -2 (Human herpes virus 1 and 2), are two members of the herpes virus family, Herpesviridae, that infect humans. Active virus excretion in genital secretions of pregnant women may result in severe neonatal HSV infection contracted when the infant passes through an infected genital tract. When HSV lesions are present during delivery, 40% to 60% of the neonates can be affected. Transmission of HSV infection to neonates is associated with high morbidity and mortality rates if untreated.The first humoral immune response to infection is the synthesis of specific anti-HSV IgM antibody which becomes detectable one week after infection. Normally this is a proof of recent or recurrent infection. Detection of IgG allows assessment of the patient’s immune status and provides serological evidence of prior exposure to HSV. This may aid in the diagnosis of recent (primary or recurrent) HSV infection in paired sera by the presence of seroconversion to HSV-1 or HSV-2 antibody. Since HSV-1 and HSV-2 share common antigenic determinants, antibody directed against one viral type may cross react with the other viral type. Truly type-specific antibody tests are based on glycoprotein G1 (from HSV-1) and glycoprotein G2 (from HSV-2), as these proteins exhibit very limited homology. The CDC recommends the use of type-specific glycoprotein G based assays when serology is performed.

Measurement Principle

This assay is based upon the two-step indirect method. In the first step, sample and recombinant HSV-2 antigens coated microparticles are combined. During the incubation, the antibodies present in the sample bind to the HSV-2 antigens coated on the microparticles. After washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, the mouse anti-human IgG in the Enzyme Conjugate is allowed to react with the antibodies bound to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, antibodies in the sample and enzyme-linked mouse anti-human IgG by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HSV-2 IgG in the sample.

Introduction

Rubella is a disease caused by the rubella virus, and has a single stranded RNA genome. It is caused by a virus that is spread through the air or by close contact. The illness follows a typically benign clinical course with rare complications and is subclinical in a large proportion of cases. Symptomatology is generally mild, characterized by fever, malaise, a maculopapular rash of three to five days duration and, possibly, coryza and conjunctivitis. The disease is usually accompanied by lymphadenopathy. Infection confers lifelong immunity. Infection from rubella virus is particularly disastrous if contracted during the first four months of gestation. If not immunologically protected, women infected during pregnancy run a high risk of embryo fetal damage. Congenital rubella causes a wide range of severe defects, many of which are permanent and adversely affect later development (cataract, deafness, hepatosplenomegaly, psychomotor retardation, bone alterations, cardiopathies, neuropathies). Rubella infection of children and adults is usually mild, self-limiting and often asymptomatic. The prognosis in children born with congenital rubella syndrome is poor. This test is helpful to determine if you have sufficient rubella antibodies to protect you from the rubella virus; to verify a past infection or detect a recent infection. The ELISA method for rubella antibody is most common and is the test done to see if a woman who is pregnant or planning to get pregnant is immune to rubella.

Measurement Principle 

This assay is based upon the two-step indirect method. The sample and natural rubella coated microparticles are combined. The rubella IgG present in the sample bind to the antigen coated on the microparticles. After washing, Enzyme Conjugate is added to the reaction mixture. During the incubation, the mouse anti-human IgG in the Enzyme Conjugate are allowed to react with the rubella IgG attached to the solid phase. Then a complex is generated between the solid phase, the rubella IgG in the sample and the mouse anti-human IgG in the Enzyme Conjugate by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of rubella IgG in the sample.

Introduction

Toxoplasmosis is a quite widespread infectious disease caused by an intracellular protozoan parasite, called Toxoplasma gondii. The disease, affecting both human and warm blooded animals, can be transmitted by ingestion of food infected; direct contagion from domestic animals; or transplacental infection. In the normal adult population, toxoplasmosis has a generally benign course, being largely asymptomatic; sometimes mildly symptomatic (headache, sore throat, asthenia); or in rare cases accompanied by lymphadenitis. Exceptionally, severer disorders may be present, like myocarditis, hepatitis, pneumonia, meningoencephalitis and retinochoroiditis.The prevalence of positive serological tests increases with age, indicating past exposure. If the infection occurs in pregnant women, toxoplasmosis can cause a threat to the fetus with possible spontaneous abortion, prematurity or stillbirth, as the pathogen can be transmitted to the fetus via the placenta. The fetus whose mother is exposed to Toxoplasma infection during the first trimester of pregnancy develops severe lesions to the central nervous system that generally lead to fetal demise. Toxoplasma infection acquired during the second trimester may cause hydrocephalus, mental and psychomotor retardation, blindness and cerebral calcifications. Toxoplasma infection, however, is commonest during the third trimester, causing retinochoroiditis and other ocular lesions, lesions to the central nervous system and latent asymptomatic infection which may eventually develop into full-blown disease.Specific IgM antibodies to Toxoplasma develop two to four weeks after the onset of clinical signs and gradually decline thereafter, disappearing in three to nine months.Therefore, the presence of IgM and IgA in the absence of IgG or in the presence of low IgG levels is a strong evidence of acute toxoplasmosis. Conversely, the presence of IgM in the presence of decreasing or constant IgG levels indicates sub-acute infection. The differential diagnosis of acute toxoplasmosis made possible by the specific IgM assay allows adequate treatment which reduces the risks of the disease both in immune-compromised patients and in pregnant women. Specific IgG antibodies to Toxoplasma rise gradually and peak two to five months after the onset of clinical signs. Therefore, the presence of IgG is useful in distinguishing subjects having acquired the disease from those who have not.This is particularly important in order to adopt suitable prophylaxis in susceptible women of child-bearing age.

Measurement Principle 

This assay is based upon the two-step indirect method. The sample, Toxo antigen coated microparticles are combined. IgG antibodies to Toxoplasma present in the sample bind to the Toxo antigens coated on the microparticles. After washing, Enzyme Conjugate is added. During the incubation, a complex is generated among the solid phase, the Toxo IgG within the sample and HRP-conjugated anti-human IgG by immunological reactions. The complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of Toxo IgG in the sample.

Introduction

AFP (alphafetoprotein) is a glycoprotein with a molecular weight of approximately 70,000 Daltons. AFP is produced mainly by the fetal yolk sac and fetal liver and to a lesser extent by the fetal gastrointestinal tract and kidneys. Elevation of serum AFP to abnormally high values occurs in several malignant diseases, most notably primary hepatocellular carcinoma and nonseminomatous testicular cancer. Approximately 70% of patients with primary hepatocellular carcinoma show elevated levels of AFP.In the case of testicular teratoma, a direct relationship has been observed between incidence of elevated AFP levels and the stage of disease. No increased AFP levels are found in testicular seminomas. The application of AFP measurement to the management of carcinoma patients has been well documented.In addition, elevated serum AFP concentrations have been measured in patients with other non-cancerous diseases, including ataxia telangiectasia, hereditary tyrosinemia, neonatal hyperbilirubinemia, acute viral hepatitis, chronic active hepatitis, and cirrhosis. Elevated serum AFP concentrations are also observed in pregnant women. Therefore, AFP measurements are not recommended for use as a screening procedure to detect the presence of cancer in the general population.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and AFP antibody coated microparticles are combined. During the incubation, AFP antigen present in the sample binds to the antibody coated microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the AFP antigen within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of AFP in the samples.

Introduction

CEA (carcinoembroyonic antigen) is a cell-surface 200kD glycoprotein. It was first described by Gold and Freedman in 1965 as a complex immunoreactive glycoprotein found in epithelial adenocarcinomas of the colon and fetal colon. Increased levels of CEA are observed in more than 30% of patients with cancer of the lung, liver, pancreas, breast, colon, head or neck, bladder, cervix, and prostate. Elevated plasma levels are related to the stage and extent of the disease, the degree of differentiation of the tumor, and the site of metastasis. Its main use is in the monitoring of cancer patients after surgery, chemotherapy or radiotherapy.Successful removal of the tumor is usually followed by a decrease in the concentration of circulating CEA,whereas recurrence of the primary tumor or metastasis is accompanied by increasing concentrations.Elevated serum levels of CEA may be found in a variety of benign and malignant conditions other than carcinoma of the colon. Conditions that may cause elevated levels of CEA include hepatic cirrhosis, hepatitis, heavy smoking, bronchitis, pancreatitis, gastritis, inflammatory bowel disease and renal disease.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, CEA antibody coated microparticles and enzyme labeled Anti-CEA are combined. CEA present in the sample is allowed to react simultaneously with the two antibodies, resulting in the CEA being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated among the microparticles, the CEA within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of CEA in the samples.

Introduction

Tumor cells express substances in the cell membrane which are not usually produced in healthy cell membranes. The determination of these tumor-associated structures is a valuable tool in the diagnosis of malignant disorders. CA50 (cancer antigen 50), a cancer associated carbohydrate marker, is not organ-specific and its elevated levels in serum can be observed in a variety of malignancies, especially gastrointestinal cancers (e.g. pancreatic, stomach, hepatic and colorectal cancers). Benign liver and biliary diseases also are associated with increased CA50 serum levels. The mechanism whereby CA50 increases in these patients is unclear. CA50 is a tumor marker defined by the monoclonal antibody CA50 that recognizes two different structures: sialylated Lewis ganglioside antigen and sialylated lacto-N-tetraose. The CA50 antigens occur in the cell membrane in a lipid-bound form (as ganglioside) and in a form bound to a high molecular weight protein (as glycoprotein). The CA50 antigens are released by the tumors into the blood stream where they can be specifically detected by means of immunological techniques based on CA50 MAB.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and CA50 antibody coated microparticles are combined. During the incubation, CA50 antigen present in the sample binds to the antibody coated microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the CA50 antigen within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of CA50 in the samples.

Introduction

CA125 (Cancer Antigen 125) is a surface antigen associated with epithelial ovarian cancer. In serum, CA125 is associated with a high molecular weight glycoprotein. Published studies have indicated that elevated serum CA125 levels can be found in individuals with serious endometroid, clear-cell and undifferentiated ovarian carcinoma. Serum CA125 levels higher than normal can also be found in individuals with adenocarcinoma of the fallopian tube endometrium, certain non-gynecologic malignancies and some non-malignant conditions.   Serum CA125 assay values are useful for monitoring the course of disease in patients with invasive epithelial ovarian cancer. In a review of nine published studies, the overall correlation reported between CA125 serum levels and the course of the disease was 87%.Serum levels of CA 125 greater than 35 units per mL, combined with pelvic examination increases the test specificity. Serial determinations of serum CA125 further enhances the positive predictive value of the test for ovarian cancer. Serum CA125 concentration may be useful in monitoring patients with diagnosed ovarian cancer. Persistently rising CA125 assay values may be associated with malignant disease and poor response to therapy, whereas decreasing CA125 assay values may indicate a favorable response to therapy.In women with primary epithelial ovarian carcinoma who had undergone first-line therapy and were candidates for diagnostic second-look procedures, a CA125 assay value greater than or equal to 35 U/mL was found to be indicative of the presence of residual tumor. However, a CA125 assay value below 35 U/mL does not indicate the absence of residual ovarian cancer because patients with histopathologic evidence of ovarian carcinoma may have CA125 assay values within the range of normal individuals. Elevations of CA125 assay values have been reported in approximately 1- 2% of healthy individuals, and in individuals with nonmalignant conditions such as cirrhosis, hepatitis, endometriosis, first trimester pregnancy, ovarian cysts, and pelvic inflammatory disease. Elevations of CA125 assay values during the menstrual cycle have also been reported. Non-ovarian malignancies in which elevated CA125 assay values have been reported include cervical, liver, pancreatic, lung, colon, stomach, biliary tract, uterine, fallopian tube, breast, and endometrial carcinomas.  To date, CA125 is the most sensitive marker for residual epithelial ovarian cancer.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, anti-CA125 coated microparticles and enzyme labeled CA125 antibody are combined. CA125 present in the sample is allowed to react simultaneously with the two antibodies, resulting in the CA125 being sandwiched between the microparticles and enzyme-linked antibodies. After washing, a complex is generated between the solid phase, the CA125 within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of CA125 in the samples.

Introduction

Breast cancer is the most common life-threatening malignant lesion in women of many developed countries today, with approximately 180,000 new cases diagnosed every year. Roughly half of these newly diagnosed patients are node-negative, however 30% of these cases progress to metastatic disease.  Research studies have indicated that CA15-3 assay values are frequently elevated in patients with breast cancer. These studies have suggested that the CA15-3 assay may be of clinical value for monitoring the response of patients undergoing therapy because increasing and decreasing values correlated with disease progression and regression, respectively. Additional published studies have suggested that increasing CA15-3 assay values in patients at risk for breast cancer recurrence after primary therapy may be indicative of recurrent disease before it can be detected clinically.Elevations of CA15-3 assay values have been reported in individuals with nonmalignant conditions such as cirrhosis, hepatitis, autoimmune disorders, and benign diseases of the ovary and breast. Non-mammary malignancies in which elevated CA15-3 assay values have been reported include lung, colon, pancreatic, primary liver, ovarian, cervical, and endometrial. CA15-3 assay values are not elevated in most normal individuals. The CA15-3 assay is not recommended as a screening procedure to detect cancer in the general population; however, use of the CA15-3 assay as an aid in the management of breast cancer patients has been reported.

Measurement Principle   

This assay is based upon the one-step sandwich method. The sample, CA15-3 antibody coated microparticles and enzyme labeled CA15-3 antibody are combined. CA15-3 present in the sample reacts simultaneously with the two antibodies, resulting in the CA15-3 being sandwiched between the microparticles and enzyme-linked antibody. After washing, a complex is generated among the microparticles, the CA15-3 within the sample and enzyme-linked antibody by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of CA15-3 in the samples.

Introduction

The CA19-9 is a carbohydrate antigen predominantly associated with gastrointestinal malignancies; pancreatic, colorectal, gastric and hepatic carcinomas. The main application of CA19-9 is in the management of diagnosed pancreatic and colorectal cancers. Immunochemically, CA19-9 antigen is the sialylated form of the blood group antigen Lewis. Clinical studies indicate that CA19-9 assay levels have been found elevated in the serum with carcinomas of the exocrine pancreas, the colon and rectum, the stomach and lung cancer. It has been shown that a persistent elevation in CA19-9 assay value following treatment may be indicative of occult metastatic and/or residual disease. A persistently rising CA19-9 assay value may be associated with progressive malignant disease and poor therapeutic response. A declining CA19-9 assay value may be indicative of a favorable prognosis and a good response to treatment.Increased serum CA19-9 assay values have also been observed in patients with nonmalignant conditions such as hepatitis, cirrhosis, pancreatitis, and other gastrointestinal disease. The CA19-9 concentration should always be interpreted taking into consideration other clinical data and should not be used as a cancer screening test.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and CA19-9 antibody coated microparticles are combined. During the incubation, CA19-9 antigen present in the sample binds to the antibody coated the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the CA19-9 antigen within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of CA19-9 in the samples.

Introduction

Beta-2-microglobulin (β2-Microglobulin) is expressed by the nucleated cells of the body and on many tumor lines. Human β2-Microglobulin is a low molecular weight protein consisting of a single polypeptide chain of 99 amino acids . It is identical to the small chain of the HLA-A, HLA-B, and HLA-C major histocompatibility complex antigens . β2-Microglobulin normally is filtered out of the blood by the kidney’s glomeruli, it is reabsorbed and catabolized by the proximal tubular cells through endocytosis. It is found at low levels in the serum of normal individuals. Elevated β2-Microglobulin level in serum is associated with certain kinds of cancer affecting white blood cells including chronic lymphocytic leukemia, non-Hodgkin’s lymphoma, and multiple myeloma or kidney disease . In patients with rheumatoid arthritis, systemic lupus erythematosus, sarcoidosis and some viral diseases including cytomegalovirus, the β2-Microglobulin serum level changes in relation to disease activity.

Measurement Principle 

This assay is based upon one-step sandwich method. The sample β2-Microglobulin antibody coated microparticles and enzyme labeled β2-Microglobulin antibody are combined. β2-Microglobulin present in the sample reacts simultaneously with the two antibodies, resulting in the β2-Microglobulin being sandwiched between the microparticles and enzyme labeled antibody. After washing, a complex is generated among the microparticles, the β2-Microglobulin within the sample and enzyme-linked antibody by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of β2-Microglobulin in the sample.

Introduction

CA72-4 (Cancer antigen 72-4) is a high molecular weight glycoprotein complex termed TAG-72 (tumor-associated antigen 72) and recognized as antigenic determinant by B72.3 and CC49, which are murine monoclonal antibodies raised against a membrane extract of mammary carcinoma metastases. Elevated CA72-4 levels in serum have been reported in various malignant diseases including carcinomas of pancreas, stomach, gall, colon, mamma, ovaries, cervix and endometrium . Although some benign diseases such as rheumatic diseases or ovary cysts may also result in elevated levels of CA72-4, clinical studies demonstrated diagnostic specificities of more than 95% for gastrointestinal and ovarian malignancies . CA72-4 levels have a good correlation with tumor stage and size; it is the marker of choice for the therapeutic monitoring and follow-up care of gastrointestinal and ovarian cancer patients .

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and CA72-4 antibodies coated microparticles are combined. During the incubation, CA72-4 present in the sample binds to the antibody coated microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the CA72-4 within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of CA72-4 in the sample.

Introduction

Squamous cell carcinoma (SCC) is the second most common skin cancer. It is typically characterized by a red papule or plaque with a scaly or crusted surface , it may be suspected whenever a small, firm reddish-colored skin lesion, growth or bump appears on the skin, but it may also be a flat growth with a curly and crusted surface . Most often these growths are located on the face, ears, neck, hands and/or arms, but they may occur on the lips, mouth, tongue, genitalia or other area.  Squamous cell carcinoma antigen (SCCA) is a glycoprotein with a molecular weight between 42 to 48 kDa . It is a member of the serine protease inhibitor (serpin) family, is widely used as a serum marker in cancers of the uterine cervix, the head and neck, lung and esophagus. Total SCCA in the circulation comprises 2 nearly identical, approximately 45 kDa proteins, SCCA1 and SCCA2 . They are co-expressed in normal and malignant squamous epithelium, but it is mainly the acidic isoform SCCA2 that is present in the circulation of cancer patients. In patients responding to initial therapy, an elevated SCCA2/SCCA1 mRNA ratio in the primary tumor predicted recurrence independent of clinical stage. The relative risk of developing a recurrence was 7.2 in patients with elevated vs. normal SCCA2/SCCA1 mRNA ratios. SCCA2/SCCA1 mRNA ratio in primary tumors could be useful for individual selection of treatment strategy for patients with head and neck cancer.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and SCCA antibody coated microparticles are added. During the incubation, SCCA present in the sample binds to the antibodies coated microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the SCCA within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of SCCA in the sample.

Introduction

The glycolytic enzyme enolase (2-phosph-D-glycerate hydrolyase) exists as several dimeric isoenzymes (αα, αβ, αγ and γγ) composed of three distinct subunits, α, β, and γ. Three isoenzymes are found in human brain: αα, αγ and γγ. The αγ and γγ-enolase isoenzymes are also known as neuron-specific enolase (NSE) as these isoenzymes initially were detected in neurons and neuronendocrine cells.

Elevated levels of NSE are commonly found in patients with malignant tumors with neuronendocrine differentiation, especially small cell lung cancer and neuroblastoma . Approximately 20% of the lung cancer is small cell lung cancer. Patients with small cell lung cancer show various proportions of αγ and γγ isoenzyme .

NSE is reported to be useful diagnostic marker for lung cancer, neuroblastoma, melanoma, seminoma  and in injury of central nervous system. In addition to the above, NSE can be a valuable tool in following-up the effect of chemotherapy of small cell lung cancer, in prognostic evaluation of patients with small cell lung cancer, and in differential diagnosis between cell lung cancer and non-small cell lung cancer.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and anti-NSE coated microparticles are combined. During the incubation, NSE present in the sample binds to the antibodies coated microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the NSE within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of NSE in the sample.

Introduction

Cytokeratin 19 is a subunit of cytokeratin intermediate filament expressed in simple epithelia and their malignant counterparts. Therefore, it is expressed by respiratory epithelium cells and has been detected in lung cancer specimens . CYFRA 21-1 is a fragment of cytokeratin 19 which can be determined by two mouse monoclonal antibodies KS19.1 and BM19.21. Although CYFRA 21-1 expressed in all body fluids, its major presence is in the lung, its levels in serum have already been evaluated as a useful tumor marker for lung cancer, especially non-small-cell lung cancer (NSCLC) . As the most sensitive tumor marker in NSCLC, CYFRA 21-1 is used in NSCLC diagnosis and prognosis, particularly for squamous cell tumors . Besides in lung cancer, CYFRA 21-1 proved valuable for uterine carcinomas, head and neck carcinomas, gastric cancer, and recently for SCC of the esophagus in vitro and in vivo.

Measurement Principle 

This assay is based upon two-step sandwich method. In the first step, the sample and CYFRA 21-1 antibody coated microparticles are combined. During the incubation, CYFRA 21-1 present in the sample binds to the antibodies coated microparticles. After washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the CYFRA 21-1 within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the concentration of CYFRA 21-1 in the patient sample.

Introduction

tPSA (prostate specific antigen), a glycoprotein with a molecular weight of 34,000D, was first isolated by Wang et.al. in 1979. tPSA is a kallikrein-like serine protease that is produced exclusively by the epithelial cells of the prostate. tPSA is immunologically specific for prostatic tissue, it is present in normal, benign hyperplastic, and malignant prostatic tissue, in metastatic prostatic carcinoma, and also in prostatic fluid and seminal plasma. It may serve as an accurate marker for assessing response to treatment in patients with prostatic cancer. Therefore, measurement of serum tPSA concentrations can be an important tool in monitoring patients with prostatic cancer and in determining the potential and actual effectiveness of surgery or other therapies. 30-50% of patients with benign prostatic hyperplasia have elevated serum tPSA concentrations, depending on the size of the prostate and the degree of obstruction, and the concentrations are increased in 25~92% of patients with prostate cancer, depending on tumor volume. Elevated levels have not been reported for cancers of the lung, breast, colon, rectum, stomach, pancreas or thyroid. Digital rectal examination, cystoscopic examination and prostate biopsy all can cause elevations of the serum tPSA concentration2. Conditions such as bacterial prostatitis and acute urinary retention also can increase the serum tPSA level.  Recent studies also indicate that tPSA measurements can enhance early prostate cancer detection when combined with DRE (digital rectal examination). When compared to PAP (prostatic acid phosphatase), tPSA is a more precise and useful marker in all clinical situations.

Measurement Principle 

This assay is based upon the one-step sandwich method. The sample, Anti-PSA coated microparticles and enzyme labeled Anti- PSA are combined. During the incubation, tPSA present in the sample is allowed to react simultaneously with the two antibodies, resulting in the tPSA being sandwiched between the solid phase and enzyme-linked antibodies. After washing, a complex is generated between the solid phase, the tPSA within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of tPSA in the samples.

Introduction

PSA (prostate specific antigen), a glycoprotein with a molecular weight of 34,000D, was first isolated by Wang et. al. in 1979. It is mainly found in the cytoplasm of prostate acinar cells and ductal epithelium. In addition to being present in normal tissue, PSA is also present in prostatic cancerous tissue, benign hyperplastic tissue, in prostatic fluid and seminal plasma, and is therefore a useful clinical marker for prostate cancer. Two immunoreactive forms of PSA are found in serum: free and complexed PSA. The complexed form is given by the binding of ACT (alpha-1-antichymotrypsin) to the active site of PSA. The PSA molecule which is not bound to the serine protease inhibitor ACT, named Free PSA, is found in lower concentrations than the complexed form.  Current methods of screening men for prostate cancer utilize the detection of the major PSA-ACT form. Levels of 4.0 ng/ml or higher are strong indicators of the possibility of prostatic cancer. However, elevated serum PSA levels have also been attributed to benign prostatic hyperplasia and prostatitis, leading to a large percentage of false positive screening results. A potential solution to this problem involves the determination of free PSA levels. Preliminary studies have suggested that the percentage of free PSA is lower in patients with prostate cancer than those with benign prostatic hyperplasia. Thus, the measurement of free serum PSA in conjunction with total PSA, can improve specificity of prostate cancer screening in selected men with elevated total serum PSA levels, which would subsequently reduce unnecessary prostate biopsies with minimal effects on cancer detection rates. The proportion, or percent, of free PSA determined by comparing the concentration of free PSA to the concentration of total PSA has been proposed as a way to improve the discrimination between BPH and prostate cancer, especially in those men with intermediate levels of total serum PSA.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, sample and anti-fPSA coated microparticles and sample diluent are combined. During the incubation, fPSA antigen present in the sample binds to the antibody coated on the paramagnetic microparticles. After the washing, in the second step, enzyme conjugate is added to the reaction mixture. During the incubation, the enzyme labeled anti-fPSA reacts with the antigens attached to the solid phase in the first step. After a second washing, a complex is generated among the solid phase, the fPSA antigen within the sample and the antibodies in the enzyme conjugate by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of fPSA in the samples

Introduction

Human epididymis protein 4(HE4) belongs to the family of whey acidic four-disulfide core(WFDC) proteins with suspected trysin inhibitor properties. The HE4 gene codes for a 13kD protein, although in its mature glycosylated form the protein is approximately 20-25kD, and consists of a single peptide containing 2 WFDC domains. HE4 was first determined in the epithelium of the distal epididymis. It shows low expression in epithelia of respiratory and reproductive tissues including ovary, but high expression in ovarian cancer tissue. High secreted levels can also be found in the serum of ovarian cancer patients. HE4 is helpful in the risk assessment of epithelial ovarian cancer. As a single tumor marker, HE4 had the highest sensitivity for detecting ovarian cancer, especially in stage I disease, the early non-symptomatic stage. Combined with other markers such as CA125, HE4 can help determining whether a pelvic mass is benign or malignant in pre-and post-menopausal women.

Measurement Principle 

This assay is based upon the two-step sandwich method. In the first step, the sample and HE4 antibody coated microparticles are combined. During the incubation, HE4 antigen present in the sample binds to the antibody coated the microparticles. After the washing, in the second step, Enzyme Conjugate is added to the reaction mixture. During the incubation, a complex is generated among the microparticles, the HE4 antigen within the sample and enzyme-linked antibodies by immunological reactions. Chemiluminescent Substrate is added and the complex catalyzes substrate, resulting in a chemiluminescent reaction. The resulting chemiluminescent reaction is measured as RLUs. The RLU is proportional to the amount of HE4 in the samples.

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