This HEV IgG Antibody ELISA is to be used for the in vitro detection of IgG antibody to Hepatitis E Virus (HEV) in human serum or plasma. This kit is intended for laboratory research use only and is not for use in diagnostic or therapeutic procedures.
Introduction: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 characterized 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:H1927-02A: Microtiter Plate, 1x96 wells. Pre-coated with HEV antigens
H1927-02C: Non-reactive Control, 1x1ml. Inactivated normal human serum diluted in sample diluent
H1927-02D: Reactive Control, 1x1ml. Inactivated human serum
H1927-02E: Sample Diluent, 1x12ml. Buffered solution with animal serum and preservative. H1927-02F: Wash Buffer, 20X, 1x60ml. 20-fold concentrated solution of buffered surfactant. H1927-02G: Substrate A, 1x10ml. Buffered solution with H2O2. H1927-02H: Substrate B, 1x10ml. Buffered solution with TMB. H1927-02J: Stop Solution, 1x14ml. 2N sulfuric acid (H2SO4). Caution: Caustic Material! Storage and Stability:Store all kit components at 4°C. Kit is stable for 6 months after receipt when stored at 4ºC.
