[Development of a diagnostic kit of enzyme-linked immunoassay for detecting serum anti-hepatitis E virus IgG].
OBJECTIVE
To develop a diagnostic kit for detecting serum anti-hepatitis E virus (HEV) IgG with enzyme-linked immunoassay (ELISA).


METHODS
The diagnostic kit of detecting anti-HEV IgG with ELISA was prepared by two synthetic HEV peptides used for coating the solid-phase to capture the antibody against HEV in serum, and then by horseradish peroxidase antihuman IgG (gamma chain) added as the second antibody to bind the anti-HEV IgG in serum. Its sensitivity, specificity, precision and stability were measured and clinically evaluated.


RESULTS
The sensitivity, specificity, and precision of the diagnostic kit detected by the China National Institute for the Control of Pharmaceutical and Biological Products were 90% (1/10), 100% (0/30) and < 15%, respectively, meeting the national standards for detecting serum anti-HEV IgG with ELISA. The ELISA Kit is stable for 1 year at least under 4 degrees C. The total consistency rates were 100% (43/43) and 96.6% (86/89), as compared with Genelabs and Singaporean DBL kits. This diagnostic kit for detecting serum anti-HEV IgG with ELISA was evaluated and approved by the State Drug Administration, China and a certificate was conferred in 1998.


CONCLUSIONS
The diagnostic kit for detecting anti-HEV IgG with ELISA can be used for epidemiological studies and clinical diagnosis of HEV infection.
Zhuang
H
H
Department of Microbiology, Peking University Health Science Center, Beijing 100083, China.
Cui
Y
Y
Zhu
W
W
D000914:Antibodies, Viral / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay / Q000592:standards; D016751:Hepatitis E / Q000175:diagnosis*; D016752:Hepatitis E virus / Q000737:chemistry / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood*; D010455:Peptides / Q000138:chemical synthesis / Q000276:immunology; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000914:Antibodies, Viral; D007074:Immunoglobulin G; D010455:Peptides; D011933:Reagent Kits, Diagnostic