ImmuDex Products
ImmuDex Business Division
Microwell Immunoassays still form the backbone technology for various clinical diagnostic analytes. In spite of being vastly popular and used across the diagnostic landscape, attaining high performance characteristics and delivering trustworthy analytical reports are still considered a key challenge.
ImmuDex product vertical focuses on microwell assays, be it ELISA or Chemiluminescence (CLIA) based parameters. Our LisaDex (ELISA) & LumiDex (CLIA) range of assay kits deliver excellent performance standards and offer truly innovative solutions towards practical considerations of customer centric operational demands. Hapten intends to introduce automated immunoassay analysers dedicated towards esoteric infectious diseases, autoimmunity, fertility and infertility related markers, endocrine functions and other relevant segments.
IgE (Immunoglobulin E)
Measurement of immunoglobulin E (IgE) in serum is widely used in the diagnosis of allergic diseases and parasitic infections. Before starting with any therapy, it is important to know whether the allergic reaction is IgE mediated or non-IgE mediated.
Measurement of total IgE in serum sample, along with other specific allergy diagnostic tests will help to make this clinical decision. Measurement of total circulating IgE may also be of value in the early detection of allergy in infants and as a means of predicting future atopic manifestations. Significant elevation of IgE levels is also observed in IgE myeloma, pulmonary aspergillosis and during the active stages of parasitic infections.
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 5, 25, 50, 150, 400 IU/ml |
Sensitivity | 0.125 IU/ml |
Linearity | 400 IU/ml |
Total Time | 75 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 5, 25, 50, 150, 400 IU/ml |
Sensitivity | 0.023 IU/ml |
Linearity | 400 IU/ml |
Total Time | 65 Minutes |
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Antibody-Coated Plate |
Calibrators | 0, 0.2, 0.5, 1.0, 5, 15 ng/ml |
Sensitivity | 0.044 ng/ml |
Linearity | 15 ng/ml |
Total Time | 80 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Antibody-Coated Plate |
Calibrators | 0, 0.2, 0.5, 1.0, 5, 15 ng/ml |
Sensitivity | 0.0242 ng/ml |
Linearity | 15 ng/ml |
Total Time | 65 Minutes |
AMH (Antimullerian Hormone)
Antimullerian hormone (AMH) is produced by Sertoli cells of the testis in males and by ovarian granulosa cells in females. During sexual differentiation in males, AMH is required for Mullerian duct regression. In females, AMH is not expressed during the period of sexual differentiation, assuring normal development of the female genital tract.
AMH levels accurately reflect the ovarian follicular reserve and is an extremely sensitive marker of ovarian aging and a valuable tool in the diagnosis and the recognition/recurrence of granulosa cell tumours. AMH evaluation is also of clinical importance in predicting the success of in vitro fertilization (IVF). Additionally, AMH is a diagnostic marker of polycystic ovary syndrome. Thus, clinical usefulness of AMH evaluation in different fields of gynaecological endocrinology, menopause, gynaecological oncology and assisted reproduction makes it the fastest growing diagnostic marker.
Ferritin
Ferritin is an intracellular storage protein that stores iron and releases it in a controlled mechanism. The ferritin test is typically ordered to assess iron stores in the body. Determination of ferritin is useful in the diagnosis of hypochromic, microcytic anaemias. Ferritin levels are decreased in iron deficiency anemia and are usually increased in iron overload.
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 10, 50, 150, 400, 800 ng/ml |
Sensitivity | 0.17 ng/ml |
Linearity | 800 ng/ml |
Total Time | 75 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 10, 50, 150, 400, 800 ng/ml |
Sensitivity | 0.011 ng/ml |
Linearity | 800 ng/ml |
Total Time | 65 Minutes |
CODE | ELISA (96 Tests) VAST Assay |
Principle | Competitive Assay, Streptavidin-Coated Plate |
Calibrators | Folate: 0, 1.0, 2.5, 5, 10, 25 ng/ml |
Calibrators | Vit B12: 0, 125, 250, 500, 1000, 2500 pg/ml |
Sensitivity | Folate: 0.52 ng/ml |
Sensitivity | Vit B12: 70.13 pg/ml |
Linearity | Folate: 25 ng/ml |
Linearity | Vit B12: 2500 pg/ml |
Total Time | Folate: 65 Minutes |
Total Time | Vit B12: 95 Minute |
CODE | CLIA (96 Tests) VAST Assay |
Principle | Competitive Assay, Streptavidin-Coated Plate |
Calibrators | Folate: 0, 1.0, 2.5, 5, 10, 25 ng/ml |
Calibrators | Vit B12: 0, 125, 250, 500, 1000, 2500 pg/ml |
Sensitivity | Folate: 0.23 ng/ml |
Sensitivity | Vit B12: 42.12 pg/ml |
Linearity | Folate: 25 ng/ml |
Linearity | Vit B12:2500 pg/ml |
Total Time | Folate: 50 Minutes |
Total Time | Vit B12: 80 Minutes |
Folate / Vitamin B12
Folate (Vitamin B9) and Vitamin B12 are two necessary vitamins which are very critical for the formation of RBC. Deficiency of one of these vitamins will lead to long term anaemia which is characterized by macrocytosis.
Early diagnosis of these disorders is dependent on accurate quantification of Folate and Vitamin B12. Anaemia Panel is the perfect paired analyte kit that offers a convenient product technology that combines both Folate and Vitamin B12. Anaemia VAST based assays are built on the Streptavidin-Biotin based advanced assay format. Streptavidin coated plates provide a generic surface for immobilization of any of the two analyte-specific antibodies such as biotinylated folate binding protein and biotinylated Anti-Vitamin B12 antibody. Streptavidin-Biotin offers multiple advantages and provides the flexibility to the user to perform multiple analytes from a single kit.
Folate
Folate plays an important role in brain development and therefore is vital during growth. The most common defects which results from folate deficiencies are neural tube defects.
With a vital role in nucleic acid synthesis, folate has been found to be beneficial as supplementation during pregnancy and other times of rapid tissue growth.
Folate also plays a vital role in maintaining proper balance of homocysteine, a contributing factor in occurrences of occlusive vascular diseases and stroke.
CODE | ELISA (96 Tests) |
Principle | Competitive Assay, Streptavidin-Coated Plate |
Calibrators | 0, 1, 2.5, 5, 10, 25 ng/ml |
Sensitivity | 0.52 ng/ml |
Linearity | 25 ng/ml |
Total Time | 65 Minutes |
CODE | CLIA (96 Tests) |
Principle | Competitive Assay, Streptavidin-Coated Plate |
Calibrators | 0, 1, 2.5, 5, 10, 25 ng/ml |
Sensitivity | 0.234 ng/ml |
Linearity | 25 ng/ml |
Total Time | 50 Minutes |
CODE | ELISA (96 Tests) |
Principle | Delayed-Competitive Assay, Streptavidin-Coated Plate |
Calibrators | 0, 100, 200, 400, 1000, 2000 pg/ml |
Sensitivity | 70.13 pg/ml |
Linearity | 2000 pg/ml |
Total Time | 95 Minutes |
CODE | CLIA (96 Tests) |
Principle | Delayed-Competitive Assay, Streptavidin-Coated Plate |
Calibrators | 0, 100, 200, 400, 1000, 2000 pg/ml |
Sensitivity | 37.92 pg/ml |
Linearity | 2000 pg/ml |
Total Time | 80 Minutes |
Vitamin-B12
Vitamin-B12 is one of the nine water soluble vitamins important for healthy body functioning. Vitamin-B12 (cobalamin) is necessary for hematopoiesis and normal neuronal function.
The most important roles Vitamin-B12 plays in the human body are in the formation of red blood cells and the formation of myelin sheath around the nerves. In humans, it is obtained only from animal proteins and requires intrinsic factor (IF) for absorption. Vitamin-B12 deficiency may arise due to lack of intrinsic factor secretion by gastric mucosa or intestinal malabsorption. Vitamin-B12 deficiency frequently causes macrocytic anemia, glossitis, peripheral neuropathy, weakness, hyperreflexia, ataxia, loss of proprioception, poor coordination and behavioural changes. Pernicious anemia is a macrocytic anemia caused by Vitamin-B12 deficiency that is due to a lack of IF secretion by gastric mucosa.
Vitamin-D
Vitamin-D a fat-soluble secosteroid hormone required for management of calcium and phosphorus concentrations required in the mineralization of bone. Vitamin D is important for calcium homeostasis and for optimal skeletal health. Vitamin D deficiency has been associated to diseases related to bone damage such as osteomalacia and rickets. The sum of the 25-OH Vitamin D in serum or plasma is referred to as Total 25OH Vitamin D. The accurate measurement of Total Vitamin D is necessary in monitoring deficient Vitamin D patients to achieve the optimum dosage and avoid excessive levels, which are considered to be toxic.
CODE | ELISA (96 Tests) |
Principle | Competitive Assay, Antibody-Coated Plate |
Calibrators | 0, 5, 10, 25, 46, 85, 150 ng/ml |
Sensitivity | 1.14 ng/ml |
Linearity | 150 ng/ml |
Total Time | 80 Minutes |
CODE | CLIA (96 Tests) |
Principle | Competitive Assay, Antibody-Coated Plate |
Calibrators | 0, 5, 10, 25, 46, 85, 150 ng/ml |
Sensitivity | 0.517 ng/ml |
Linearity | 150 ng/ml |
Total Time | 60 Minutes |
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Antibody-Coated Plate |
Calibrators | 0, 0.4, 1.25, 2.5, 7.5, 20 ng/ml |
Sensitivity | 0.0759 ng/ml |
Linearity | 20 ng/ml |
Total Time | 30 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Antibody-Coated Plate |
Calibrators | 0, 0.4, 1.25, 2.5, 7.5, 20 ng/ml |
Sensitivity | 0.0853 ng/ml |
Linearity | 20 ng/ml |
Total Time | 20 Minutes |
Troponin
Troponin is a complex that regulates the contraction of striated muscle. It consists of 3 subunits (C, T and I) that are located periodically along the thin filament of the myofibrils. The Cardiac (C) form of Troponin I is the only troponin isotope present in the myocardium and is not expressed during any developmental stage in skeletal muscles.
The cardiac specific isoforms of Troponin I (cTnI) has been known as a marker of heart damage and myocardial cell death, due to myocardial infarction. Cardiac Troponin I is released into the bloodstream within hours of the onset of symptoms of myocardial infarction or ischemic damage. It can be detected at 3 to 6 hours following onset of chest pain with peak concentrations at 12 to 16 hours and remains elevated for 5 to 9 days. The troponin test helps in diagnosing a heart attack, to detect and evaluate mild to severe heart injury and to separate it from chest pain that may be due to other causes. Raised cardiac troponin concentrations are now accepted as the standard biochemical marker for the diagnosis of myocardial infarction due to sensitivity and specificity.
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 5, 25, 100, 200, 400 ng/ml |
Sensitivity | 0.182 ng/ml |
Linearity | 400 ng/ml |
Total Time | 30 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 5, 25, 100, 200, 400 ng/ml |
Sensitivity | 0.5 ng/ml |
Linearity | 400 ng/ml |
Total Time | 20 Minutes |
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 0.5, 2.0, 5, 15, 30 µg/ml |
Sensitivity | 0.014 µg/ml |
Linearity | 30 µg/ml |
Total Time | 30 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 0.5, 2.0, 5, 15, 30 µg/ml |
Sensitivity | 0.007 µg/ml |
Linearity | 30 µg/ml |
Total Time | 20 Minutes |
hs-CRP
CRP is one of the acute phase proteins, the circulatory levels of which rises as a response to a wide variety of diseases. C-reactive protein (CRP) is a considered to be a biomarker of inflammation. Plasma CRP concentrations increase rapidly and dramatically (100-fold or more) in response to tissue injury or inflammation. Atherosclerosis is an inflammatory disease and thus measurement of high sensitivity CRP (hs-CRP) has been endorsed by multiple guidelines as a biomarker of atherosclerotic cardiovascular disease risk. With the advent of sensitive methodologies, the use of hs-CRP aids in the determination of inflammation due to cardiovascular trauma.
Myoglobin
Acute myocardial infarction (AMI) disrupts cardiac cell membranes, releasing intracellular cardiac proteins into the vascular system. Myoglobin, being the smallest of these markers, diffuses rapidly throughout the vascular system and provides the earliest indication of AMI. Myoglobin is one of the most important myocardial markers used in ruling AMI within 2 hours of admission because of chest pains. Myoglobin levels rise between 0.5-2.0 hours after the onset of chest pain and peak within 5-12 hours. The kidneys rapidly eliminate myoglobin from the system, restoring normal circulating concentrations within 16-36 hours.
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 10, 25, 50, 150, 400 ng/ml |
Sensitivity | 0.178 ng/ml |
Linearity | 400 ng/ml |
Total Time | 30 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 10, 25, 50, 150, 400 ng/ml |
Sensitivity | 0.03 ng/ml |
Linearity | 400 ng/ml |
Total Time | 20 Minutes |
CODE | ELISA (96 Tests) VAST Assay |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | Insulin: 0, 5, 25, 50, 100, 300 µlU/ml |
Calibrators | C-peptide: 0, 0.2, 1, 2, 5, 10 ng/ml |
Sensitivity | Insulin: 0.182 µlU/ml |
Sensitivity | C-peptide: 0.020 ng/ml |
Linearity | Insulin: 300 µlU/ml |
Linearity | C-peptide:10 ng/ml |
Total Time | 135 Minutes (for both assay) |
CODE | CLIA (96 Tests) VAST Assay |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | Insulin: 0, 5, 25, 50, 100, 300 µlU/ml |
Calibrators | C-peptide: 0, 0.2, 1, 2, 5, 10 ng/ml |
Sensitivity | Insulin: 0.114 µlU/ml |
Sensitivity | C-peptide: 0.012 ng/ml |
Linearity | Insulin: 300 µlU/ml |
Linearity | C-peptide:10 ng/ml |
Total Time | 65 Minutes (for both assay) |
C-Peptide & Insulin
C-Peptide and insulin test are performed to diagnose and differentiate between type 1 and type 2 diabetes. Diabetes Panel is the perfect paired analyte kit that offers a convenient product technology that can measure both C-Peptide and Insulin. Diabetes VAST based assays are built on Streptavidin-Biotin based advanced assay format.
Streptavidin coated plates provides a generic surface for immobilization of both biotinylated Anti-insulin Antibody and biotinylated Anti-C-Peptide antibody. Streptavidin-Biotin offers multiple advantages and provides the flexibility to the user to perform multiple analytes from a single kit.
C-Peptide
Insulin and C-Peptide are produced by enzymatic cleavage of proinsulin in the pancreas. C-Peptide is devoid of any biological activity but appears to be necessary to maintain the structural integrity of insulin. In-vitro determination of insulin and C-Peptide levels help in the differential diagnosis of liver disease, acromegaly, Cushing’s syndrome, familial glucose intolerance, insulinoma, renal failure, ingestion of accidental oral hypoglycemic drugs or insulin-induced factitious hypoglycemia. C-Peptide determination can help to evaluate the production of endogenous insulin. To distinguish insulinomas from factitious hypoglycemia due to insulin administration, serum C-peptide values are recommended.
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 0.2, 1, 2, 5, 10 ng/ml |
Sensitivity | 0.020 ng/ml |
Linearity | 10 ng/ml |
Total Time | 135 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 0.2, 1, 2, 5, 10 ng/ml |
Sensitivity | 0.012 ng/ml |
Linearity | 10 ng/ml |
Total Time | 65 Minutes |
CODE | ELISA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 5, 25, 50, 100, 300 µlU/ml |
Sensitivity | 0.182 µlU/ml |
Linearity | 300 µlU/ml |
Total Time | 135 Minutes |
CODE | CLIA (96 Tests) |
Principle | Sandwich Assay, Streptavidin-Coated Plate |
Calibrators | 0, 5, 25, 50, 100, 300 µlU/ml |
Sensitivity | 0.114 μIU/ml |
Linearity | 300 µlU/ml |
Total Time | 65 Minutes |
Insulin
Human insulin is a peptide produced in the beta cells of the pancreas and is responsible for the metabolism and storage of carbohydrates. As a result of biofeedback, the insulin levels increase with intake of sugars and decline when sugar content is low for absorption. In the diabetic patient, the mechanism of insulin production is impaired because of genetic predispositions (Type I) or because of lifestyle and/or hereditary factors (Type II). In such cases either the insulin production must be increased by medication, or it has to be supplemented by oral or intravenous methods. The quantitative determination of insulin can help in diagnosis, dose selection and appropriate treatment for a diabetic patient. On the other hand, the circulatory insulin levels are found at much higher in patients with pancreatic tumours causing hypoglycemia.
Triple Screen Panel - AFP, hCG, uE3
VAST Triple Screen Panel is a single kit for estimation of AFP, hCG, uE3. The Triple Screen VAST Panel combines critical markers for monitoring of foetal well-being during pregnancy. VAST Triple Screen kit enables the user to perform 3 different analytes from a single kit. Monitoring of hCG, AFP and uE3 concentrations, at regular intervals, is considered to be important to determine the status of foetal.
The collective information provide by these three assays (Triple Screen) provides the clinician with the comprehensive picture of the development of a healthy foetus and the health of the mother. Triple Screen provides the clinician with a single tool to monitor all three analytes in a single combination assay. VAST based assays are built on Streptavidin-Biotin based advanced assay format. Streptavidin coated plates provides a generic surface for immobilization of any of the four-analyte specific biotinylated antibodies. Streptavidin-Biotin offers multiple advantages and provides the flexibility to the user to perform 4 different analytes from a single kit.
CODE | ELISA (96 Tests) VAST Assay |
Principle | Competitive Assay, Streptavidin-Coated Plate |
Calibrators | AFP: 0, 10, 25, 75, 150, 400 ng/ml |
Calibrators | hCG: 0, 10, 25, 50, 100, 250 mlU/ml |
Calibrators | uE3: 0, 0.5, 1.0, 2.5, 10, 20 ng/ml |
Sensitivity | AFP: 1.0 ng/ml |
Sensitivity | hCG: 0.8 mlU/ml |
Sensitivity | uE3: 0.115 ng/ml |
Linearity | AFP: 400 ng/ml |
Linearity | hCG: 250 mlU/ml |
Linearity | uE3: 20 ng/ml |
Total Time | 75 Minutes (for all the assays) |
CODE | CLIA (96 Tests) VAST Assay |
Principle | Competitive Assay, Streptavidin-Coated Plate |
Calibrators | AFP: 0, 10, 25, 75, 150, 400 ng/ml |
Calibrators | hCG: 0, 10, 25, 50, 100, 250 mlU/ml |
Calibrators | uE3: 0, 0.5, 1.0, 2.5, 10, 20 ng/ml |
Sensitivity | AFP: 1.0 ng/ml |
Sensitivity | hCG: 0.8 mlU/ml |
Sensitivity | uE3: 0.115 ng/ml |
Linearity | AFP: 400 ng/ml |
Linearity | hCG: 250 mlU/ml |
Linearity | uE3: 20 ng/ml |
Total Time | 50 Minutes (for all the assays) |