[Development and assessment of a chemiluminescence assay kit for detecting anti-HEV IgG].
OBJECTIVE
To develop an anti-hepatitis E virus (anti-HEV) IgG chemiluminescence assay kit and assess its clinical application.


METHODS
The HEV recombinant antigen was used as coating antigen, horseradish peroxidase (HRP)-conjugated monoclonal anti-human IgG as the secondary antibody, and the luminol chemiluminescent reaction system as a substrate. The sensitivity, specificity, precision and other technical indicators of the kit were evaluated using the HEV national reference product, and a contrast experiment was conducted on 1012 serum samples by the kit developed in this research and a commercialized anti-HEV IgG chemiluminescence assay kit.


RESULTS
The sensitivity, specificity, precision and stability of all the three batches of kit reached national standard. In the detection of 1012 clinical serum samples, the positive coincidence rate of both kits was 97.4%, the negative coincidence rate was 99.4%, and the total coincidence rate reached 98.4%.


CONCLUSIONS
An anti-HEV IgG chemiluminescence assay kit has been successfully developed. The kit is of high sensitivity and specificity, easy to operate. It is applicable to the clinical diagnosis and epidemiological survey of HEV infection.
Chinese PLA Medical School, Beijing 100853; Center for Therapeutic Research of Hepatocellular Carcinoma, 302 Military Hospital of China, Beijing 100039, China.
Minna
M
Zhang
Research and Technology Service Center, 302 Military Hospital of China, Beijing 100039, China.
Yan
Y
Hu
Research and Technology Service Center, 302 Military Hospital of China, Beijing 100039, China.
Jun
J
Hou
Research and Technology Service Center, 302 Military Hospital of China, Beijing 100039, China.
Rong
R
Gao
Beijing KEWEI Clinical Diagnostic Reagents Co, LTD, Beijing 100043, China.
Sujuan
S
Shi
Beijing KEWEI Clinical Diagnostic Reagents Co, LTD, Beijing 100043, China.
Baojun
B
Wang
Beijing KEWEI Clinical Diagnostic Reagents Co, LTD, Beijing 100043, China.
Weijun
W
Ou
Center for Therapeutic Research of Hepatocellular Carcinoma, 302 Military Hospital of China, Beijing 100039, China.
Yongping
Y
Yang
Chinese PLA Medical School, Beijing 100853; Research and Technology Service Center, 302 Military Hospital of China, Beijing 100039, China.
Panyong
P
Mao
D016752:Hepatitis E virus / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis* / Q000097:blood / Q000276:immunology*; D007202:Indicators and Reagents / Q000737:chemistry; D007700:Kinetics; D008163:Luminescent Measurements / Q000379:methods*; D015203:Reproducibility of Results
D007074:Immunoglobulin G; D007202:Indicators and Reagents