Performance comparison of four IgM antibody diagnostic kits for hepatitis E virus in an outbreak
10.3760/cma.j.cn112866-20191116-00180
- VernacularTitle:4种戊型肝炎病毒IgM抗体诊断试剂在一起暴发疫情中的性能比较
- Author:
Wenjiao YIN
1
;
Hongtu LIU
;
Fachun JIANG
;
Jingyuan CAO
;
Wenbo XU
;
Shengli BI
Author Information
1. 中国疾病预防控制中心病毒病预防控制所 国家卫生健康委员会医学病毒和病毒病重点实验室，北京 102206
- Keywords:
Hepatitis E;
Enzyme-linked immunosorbent assay;
Immunoglobulin M;
Performance comparison
- From:
Chinese Journal of Experimental and Clinical Virology
2020;34(2):207-211
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the diagnostic performance of four IgM antibody diagnostic kits for hepatitis E virus (HEV) in an outbreak.Methods:Four reagent kits were used to detect the IgM antibody to HEV in serum samples of the subjects in an outbreak of hepatitis E, and the HEV RNA was detected; statistical analysis was carried out.Results:The detection rates of HEV IgM antibody with MP, Kehua, Wantai and Beier′s reagent kits were 40.00% (108/270), 29.26% (79/270), 28.52% (77/270) and 20.37% (55 /270), respectively, with a consistency rate of 78.52% (212/270). For HEV RNA positive samples, the sensitivity of MP, Kehua and Wantai’s reagents was 66.67% (32/48) and that of Beier’s reagent was 58.33% (28/48). The sensitivity of MP, Kehua and Wantai’s reagents was 69.81% (37/53) and that of Beier’s reagent was 60.38% (32/53) for sera from patients with acute hepatitis E. The detection rates of HEV IgM antibody in serum samples of RNA positive or acute hepatitis E clinical diagnosis cases of Beier-Kehua and Beier-Wantai were significantly different (McNemar’s test: P<0.05), but there was no significant difference between the detection rates of other reagents (McNemar’s test: P>0.05); for serum samples of HEV RNA negative or clinically excluded cases of acute hepatitis E, the detection rates of HEV IgM antibody of Kehua and Wantai’s reagents were the most similar (McNemar’s test: P>0.05), but the detection result of other reagents were significantly different (McNemar’s test: P<0.05). Conclusions:The diagnostic kits of MP, Kehua and Wantai for HEV IgM antibody have high sensitivity and are suitable for the early serological screening of acute hepatitis E. In the outbreak of hepatitis E, comprehensive diagnosis should be made by combining the detection result of HEV IgM antibody and HEV RNA.
