Evaluation of a new point-of-care oral anti-HCV test for screening of hepatitis C virus infection

Author:

Liu Lili,Zhang Mingyuan,Hang Lei,Kong Fei,Yan Hongqing,Zhang Yumei,Feng Xiangwei,Gao Yuanda,Wang Chang,Ma Heming,Liu Xu,Zhan Mengru,Pan Yu,Xu Hongqin,Niu JunqiORCID

Abstract

Abstract Background Hepatitis C virus (HCV) infection is a public health issue for which an effective universal screening method is urgently needed. An oral anti-HCV test could provide a noninvasive and rapid screening strategy for HCV infection. This study evaluated the performance of a new point-of-care oral assay developed by Well for the detection of HCV antibody. Methods Individuals from three centers with and without HCV infection were enrolled. All participants were tested for oral HCV antibody using the Well assay and for serum HCV antibody using established tests (ARCHITECT i2000 anti-HCV assay and InTec serum anti-HCV assay). For participants who obtained positive results, HCV RNA was tested for verification. Some patients underwent the OraQuick HCV test at the same time, and some self-tested with the Well assay during the same period. Results A total of 1179 participants, including 486 patients with chronic HCV infection, 108 patients with other liver diseases, and 585 individuals who underwent physical examination, were enrolled. The Well anti-HCV test had a sensitivity of 91.88% (95% confidence interval [CI]: 88.97–94.09%) and a specificity of 98.00% (96.58–98.86%) for oral HCV antibody detection. The consistency between the Well and InTec assays was 97.02% (1138/1179). The consistency between the Well and OraQuick assays was 98.50% (197/200). Furthermore, the results of self-testing were highly consistent with those of researcher-administered tests (Kappa = 0.979). In addition, the HCV RNA results also showed that HCV RNA could only be detected on 1 of the 39 false-negative samples, and for 172 positive HCV RNA results, 171 could be detected by the Well oral anti-HCV assay. Conclusions The Well oral anti-HCV test offers high sensitivity and specificity and performed comparably to both the OraQuick assay and InTec assay for HCV diagnosis. Thus, the Well test represents a new tool for universal HCV screening to identify infected patients, particularly in regions with limited medical resources.

Funder

the National Basic Research Program of China

Publisher

Springer Science and Business Media LLC

Subject

Infectious Diseases,Virology

Reference28 articles.

1. World Health Organization. Hepatitis C, Fact sheet: WHO; 2019. Available at: https://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c (Accessed 9 Jul 2019).

2. World Health Organization. Draft Global Health sector strategies viral hepatitis 2016–2021: WHO; 2016. Available at: https://apps.who.int/iris/bitstream/handle/10665/246177/WHO-HIV-2016.06-eng.pdf;jsessionid=1E3961B87496DD1BAD171C54BF1B760F?sequence=1 (Accessed Jun 2016).

3. World Health Organization. Guidelines for the screening, care and treatment of persons with chronic hepatitis C infection. Updated version. WHO; [https://apps.who.int/iris/bitstream/handle/10665/205035/9789241549615_eng.pdf?sequence=1] (Accessed Apr 2016).

4. Ahmed M. Era of direct acting anti-viral agents for the treatment of hepatitis C. World J Hepatol. 2018;10:670–84.

5. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483–93.

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