Hepatitis E Virus, IgM BioAssay™ ELISA Kit (HEV)

This HEV IgM Bioassay ELISA kit is to be used for the in vitro detection of IgM antibody to Hepatitis E Virus (HEV) in human serum or plasma. ||Hepatitis resulting from infection with viruses other than Hepatitis A Virus (HAV) and Hepatitis B (HBV) virus was previously referred to as non-A, non-B hepatitis. The first characterised non-A, non-B hepatitis agent was that responsible for parentally transmitted non-A, non-B hepatitis, or what is now called Hepatitis C Virus. This was followed by the cloning of a portion of the fecal-orally-transmitted agent, the Hepatitis E Virus (HEV).|Hepatitis E Virus has been referred to as enterically transmitted non-A, non-B hepatitis. Epidemics of enterically transmitted Hepatitis E Virus have been recognised worldwide but |occur principally in developing countries. They have been reported in Southeast Asia, central Asia, Africa, Mexico, and Central America. In these areas, contaminated water has been implicated as the principal vehicle of virus transmission. Although HEV and HAV are transmitted in a similar manner, there are major differences in the clinical, pathological, and epidemiological courses of these two viruses. In particular, the mortality rate for HEV infection is 1 to 2%, or approximately 10-fold greater than that seen for HAV. Infection with HEV is particularly fatal for pregnant women, for whom the mortality rate can be as high as 10 to 20%. This HEV Antibody ELISA is an immunoassay, which employs synthetic and recombinant HEV antigens, for the detection of antibodies to HEV in human serum or plasma. These antigens, which correspond to the structure regions of HEV, constitute the solid phase antigenic adsorbent. Samples with O.D. values greater than or equal to the Cut-off value are defined as initially reactive. Initially reactive specimens are to be re-tested in duplicate. Samples, which do not react in either of the duplicate, repeat tests are considered non-reactive for antibodies to HEV. Samples, which are reactive in either of the duplicates tests, are considered repeatedly reactive.||Kit Components:|H1927-03A: Microtiter Plate, pre-coated with HEV antigens, 1x96 wells |H1927-03B: Pab (HRP) Conjugate, goat anti-human IgM antibody, 1x12ml |H1927-03C*: Non-Reactive Control, Inactivated normal human serum, 1x1ml|H1927-03D*: Reactive Control, Inactivated human serum, 1x1ml|H1927-03E: Sample Buffer, Buffered solution with animal serum and preservative, 1x12ml |H1927-03F: Wash Buffer, 20X, 1x60ml|H1927-03G: Substrate A, contains H2O2,1x10ml|H1927-03H: Substrate B, contains TMB, 1x10ml|H1927-03J: Stop Solution, 2N sulfuric acid (H2SO4), 1x14ml||Storage and Stability:|Store *H1927-03C and *H1927-03D at -20°C. Store other components at 4°C. Stable for 6 months after receipt. For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.