HDV IgM, BioAssay(TM) ELISA Kit

What causes Hepatitis D virus is an agent known as Delta agent (a defective 36nm-43nm RNA virus) which puts it into the classification of Hepatitis delta virus. Hepatitis D can only reproduce when it is linked with Hepatitis B virus (HBV). The disease is transmitted through the skin or through sexual contact with infected blood. Generally, the relationship of HDV and HBV involves some of the most acute and chronic HBsAg carriers. Because of this co-infection, it is important to know whether the HDV and HBV developed at the same time, or if the patient was already a carrier of HBsAg. The co-infection, especially super-infected HDV, can develop into severe acute hepatitis disease. Chronically infected HBV patients infected with HDV have a 70-80% chance of developing cirrhosis of the liver. \nSerologically, it is important to know the specific HDV antibodies (anti-HDV) or antigens. The first antibody to appear at the acute stage is IgM anti-HDV, which is transient and quickly replaced by IgG anti-HDV. If the IgM anti-HDV infection persists, a chronic HDV infection develops and continues to reproduce. Through the course of HBV-HDV co-infection, and after the tenth week of exposure, identifiable concentrations of HDV antibodies appear. If cleared up during convalescence, then evidence of recovery is shown. An important marker for diagnosis and post treatment of patients during early infection stage is the serological detection of IgM class antibodies. Early recovery during HDV co-and-acute super infection is shown by decreasing or low titers of IgM; chronic carrier stage is signaled by elevated levels of IgM. \n\nIntended Use:\nThe purpose of the HDV IgM, BioAssay(TM) ELISA Kit is for clinical lab diagnosis and treatment of patients who are suspected of having a hepatitis D virus infection. HDV IgM, BioAssay(TM) ELISA Kit is an enzyme-linked immunosorbent assay for qualitative identification of IgM-class antibodies to hepatitis D virus in human serum/plasma. \n\nSensitivity:\n100%\n\nSpecificity:\n100%\n\nRange:\nQualitative positive; negative control & cut off\n\nTest Principle:\nThe HDV IgM, BioAssay(TM) ELISA Kit employs the solid phase, two-step incubation, antibody capture assay. Antibodies directed to human IgM (anti-u chain) are pre-coated on the polystyrene microwell strips. During the first incubation stage, and after the patient's serum or plasma is diluted, any IgM antibodies present will be captured in the wells. Next, all other components of the sample are washed out, especially any IgG antibodies. What becomes visible after adding purified HDV antigens conjugated to horseradish peroxidase (HRP), is the distinct HDV IgM captured on the solid phase. In the course of the second incubation stage, conjugated antigens will individually react solely with the specific HDV IgM antibodies. Washing the wells to remove unbound conjugates is important at this juncture so that the conjugated antigens can individually react only with the specific HDV IgM antibodies. At this point, when (anti-u)-(HDV-IgM)-(HDV antigen-HRP) immunocomplex is present, a blue-colored product appears which is the result of colorless chromogens hydrolyzed by the bound HRP conjugate. After stopping the reaction with sulfuric acid, the blue color turns yellow. The color intensity can be gauged proportionally to the amount of antibody in the sample. Colorless wells appear when samples are negative for HDV-IgM. \n\nKit Components:\n1. Microwell Plate, 1x96 wells\n2. Negative Control, 1x0.5ml\n3. Positive Control, 1x0.5ml\n4. HRP-conjugate Reagent, 1x12ml\n5. Specimen Diluent, 1x12ml\n6. Stock Wash Buffer, 1x50ml \n7. Chromogen Solution A, 1x7ml\n8. Chromogen Solution B, 1x7ml\n9. Stop Solution, 1x7ml\n10. Sealable Bag, 1 unit\n11. Plate Cover, 2 sheets\n\nStorage and Stability:\nStore components at 4 degrees C. Stable for 6 months. For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.

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SPECIFICATIONS

Catalog Number

138775

Size

1Kit

Applications

ELISA

References

1. Purcell, R.H. and Gerin, J.L., Hepatitis Delta virus. In: Fields Virology, 3rd ed. Philadelphia, Lippincott-Raven, 1996. 2. Hadziyannis, S.J., Hepatitis delta: an overview. In: Rizzetto M, Purcel RH, Gerin JL, and Verme G,eds. Viral hepatitis and liver disease, Turin, Edizoni Minerva medica, 1997.\n3. Lai, M.C.C., The molecular biology of hepatitis Delta virus. Annual Review of Biochemistry, 64: 259- 286 (1995). 4. Centers for Disease Control and Prevention. Epidemiology and Prevention of Viral Hepatitis A to E: An Overview 2000.