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[Development of a diagnostic kit of enzyme-linked immunoassay for detecting serum anti-hepatitis E virus IgG]
1Department of Microbiology, Peking University Health Science Center, Beijing 100083, China.
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.
