Development and evaluation of a rapid point-of-care test for detecting the hepatitis E virus antigen
Development and evaluation of a rapid point-of-care test for detecting the hepatitis E virus antigen
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用于检测戊型肝炎病毒抗原的快速现场检测的开发和评估
DOI：
10.1016/j.clinbiochem.2018.03.001
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发表时间：
2018
影响因子：
2.8
通讯作者：
Xia Ningshao
中科院分区：
文献类型：
--
作者：
Ying Dong;Hong Congming;Wen Guiping;Tang Zimin;Wang Siling;Zhang Xu;Liu Chang;Ge Shengxiang;Zheng Zizheng;Xia Ningshao
BackgroundHepatitis E virus (HEV)-caused acute viral hepatitis is a major threat to public health worldwide. Recently, an enzyme linked immunosorbent assay (ELISA) kit detecting the HEV antigen was reported to have good concordance with the HEV RNA load and showed good clinical performance. But the ELISA kits can barely satisfy the needs of community clinics. In this study, a fluorescent microbead-based immunoassay (FMIA) for detecting the HEV antigen was developed and evaluated.MethodsA mouse anti-HEV monoclonal antibody (mAb) conjugated with fluorescent microbeads was used as capturing antibody and another mouse mAb was used as detection antibody. Overall, 150 serum samples were collected from HEV-infected patients (n = 50) and non-HEV cases (n = 100) to evaluate the performance of the FMIA.ResultsThe FMIA results showed a strong linear correlation with the viral RNA load. The diagnostic sensitivity and specificity of the HEV antigen FMIA were 92.0% (46/50) and 100.0% (100/100), respectively, and the test was consistent (kappa = 0.937,p= 0.627) with the commercial HEV antigen ELISA. The FMIA also showed good consistency with the PCR results (kappa = 0.939,p= 0.134).ConclusionsAs a rapid point-of-care (POC) test, a FMIA that is developed with acceptable performance is suitable for acute hepatitis E diagnosis, especially in developing countries and regions, because of its reduced time and simplified operation.
