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| Performance validation and clinical application of hepatitis B e antigen quantitative detection |
| GUO Yifei1, HU Yao2, JIANG Qirong1, HUANG Mingying2, LIU Aiping2, ZHANG Jiming1 |
| 1. Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200040, China; 2. Department of laboratory medicine, Huashan Hospital, Fudan University, Shanghai 200040 |
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Abstract The study validated the relevant performance of the quantitative detection system for hepatitis B e antigen (HBeAg), compared the correlation and consistency between quantitative and qualitative tests of HBeAg, and discussed the relationship between the hepatitis B virus DNA (HBV DNA) and the quantitative analysis of HBeAg, in order to provide the evidence of quantitative analysis of HBeAg in clinical diagnosis. A total of 710 patients with chronic hepatitis B who were treated at Huashan Hospital，Fudan University，from March to May 2019 were collected. According to requirements of Clinical and Laboratory Standards Institute (CLSI), the precision, analytical sensitivity, linear range/reportable range, and carrying contamination rate of the HBeAg quantitative reagent tested on Abbott ARCHITECTi4000SR automated immunoassay analyzer were verified and evaluated. The chemiluminescence microparticle immunoassay (CMIA) was used for qualitative and quantitative detection of HBeAg in 618 patients. Fluorescent quantitative PCR was applied to the quantitative of HBV DNA in patients with chronic hepatitis B, and the correlation between HBV DNA and HBeAg quantitative results was analyzed.This study confirms that HBeAg quantitative reagent test performance verification results were good, and the verified performances was content with the manufacturer’s instructions and the requirements of our laboratory. HBeAg quantitative and qualitative tests had a good correlation. 126 cases who had both HBeAg quantitative detection and HBV DNA test results showed that the two methods had a satisfactory agreement and were positively correlated. HBeAg quantitative tests can be used in routine laboratory testing to assist the clinical diagnosis and treatment of HBV infection.
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Received: 27 July 2020
Published: 25 December 2021
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Corresponding Authors:
LIU Aiping
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2021, Vol. 16 
