Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Apr;28(4):657-663.
doi: 10.1111/jvh.13466. Epub 2021 Feb 2.

Evaluation of seven rapid diagnostic tests for detection of hepatitis C virus antibodies in China

Bing Chen  1   2 , Zhong-Hui Ma  1   3 , Bing Xu  1 , Hao Chang  1 , Xiao-Xia He  4 , Li-Jian Pei  1 , Ya-Nan Ren  1 , Wen-Ge Xing  1
Affiliations

Evaluation of seven rapid diagnostic tests for detection of hepatitis C virus antibodies in China

Bing Chen et al. J Viral Hepat. 2021 Apr.

Abstract

Rapid diagnostic tests as an attractive alternative to enzyme immunoassay could identify hepatitis C virus (HCV) infected persons more expeditiously. The availability of high performing and quality-assured rapid diagnostic tests are essential to scale-up HCV screening. The study was undertaken to evaluate the performance of seven domestic HCV rapid diagnostic tests kits. The kits were evaluated by using HCV serum panels, including HCV basic panel, analytical specificity panel, mixed titre performance panel, characteristic panel, seroconversion panel, and genotype qualification panel. The results showed that clinical sensitivity, clinical specificity and analytical specificity of seven rapid diagnostic tests kits ranged from 94% (95% CI: 83.2-98.6) to 100% (95% CI: 91.5-100). Furthermore, specimens with HCV genotypes 1b, 2a, 3a, 4a, 5a, 6 could be detected by HCV rapid diagnostic tests kits, whereas specimens with genotypes 1a and 2b could not be detected. Additionally, most HCV rapid diagnostic tests kits had great performance in diagnosing different titres and/or different bands samples, but some low S/CO value specimens may not be fully detected by few rapid diagnostic test kits. In conclusion, seven HCV rapid diagnostic tests reagents presented high sensitivity, specificity, good anti-interference and detection ability of early infection, which could meet the requirements of clinical HCV antibody screening.

Keywords: hepatitis C virus; rapid diagnostic test; sensitivity; serum panel; specificity.

PubMed Disclaimer

References

REFERENCES

    1. Zhang Y, Chen LM, He M. Hepatitis C virus in mainland China with an emphasis on genotype and subtype distribution. Virol J. 2017;14(1):41.
    1. Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013;57(4):1333-1342.
    1. Easterbrook PJ, Group WHOGD. Who to test and how to test for chronic hepatitis C infection - 2016 WHO testing guidance for low- and middle-income countries. J Hepatol. 2016;65(1 Suppl):S46-S66.
    1. Chen Y, Yu C, Yin X, Guo X, Wu S, Hou J. Hepatitis C virus genotypes and subtypes circulating in Mainland China. Emerg Microbes Infect. 2017;6(11):e95.
    1. Cha YJ, Park Q, Kang ES, et al. Performance evaluation of the OraQuick hepatitis C virus rapid antibody test. Ann Lab Med. 2013;33(3):184-189.

Publication types

Substances

LinkOut - more resources