[Evaluation of the ELISA diagnostic kits for hepatitis E virus antibody in the reference serum, the suspect patients of hepatitis E and normal persons' sera].
OBJECTIVE
To evaluate the quality of the ELISA diagnostic kits for detecting hepatitis E virus (HEV) specific IgG antibody.


METHODS
Five diagnostic kits (WT, GD, HM, GeneLabs and KH) for anti-HEV IgG were assayed by detecting HEV IgG in the HEV diagnostic reference sera from 24 positive cases and 30 negative cases. 42 cases clinical suspect patients with hepatitis E from Ditan hospital in Beijing in 1994 to 1995 and 230 normal persons' sera from Chengdu city, Sichuan province in September in 2005.


RESULTS
The conformity rates of positive and negative sera was 95.83% (23) and 96.67% (29) for WT kit, 87.50% (21) and 100% (30) for GD kit, 87.50% (21) and 96.67% (29) for HM kit, 66.67% (16) and 100% (30) for GeneLabs kit, 45.83% (11) and 100% (30) for KH kit for detecting anti-HEV positive and negative reference sera, respectively. The five kits were used to detect anti-HEV IgG among 42 clinical suspect patients with hepatitis E and 230 normal persons' sera, The positive rate was 97.62% (41) and 31.74% (73) by WT, 100% (42) and 17.39% (40) by GD kit, 97.62% (41) and 23.91% (55) by HM kit, 90.48% (38) and 7.83% (18) by GeneLabs kit, 90.48% (38) and 3.48% (8) by KH, respectively.


CONCLUSIONS
The positive rates of all the 5 kits were over 90% and had a very high conformity in detecting anti-HEV IgG in clinical patient with hepatitis E, positive rates of 3.48% to 31.74% were found in detecting the normal persons' sera. The research showed insufficiency of the ELISA kits for epidemiological survey of HEV infection in population.
Jiang
Yong-zhen
YZ
Research Laboratory of Hepatitis, Institute for Viral Disease Control and Prevention, Chinese Center For Disease Control and Prevention, Beijing 100052, China. JiangYzms@sina.com
Tian
Rui-guang
RG
Lu
Jian
J
Bi
Sheng-li
SL
D000293:Adolescent; D000328:Adult; D002681:China; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation / Q000379:methods; D006508:Hepatitis Antibodies / Q000097:blood*; D016751:Hepatitis E / Q000097:blood / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
D006508:Hepatitis Antibodies; D007074:Immunoglobulin G; D011933:Reagent Kits, Diagnostic