Abstract
BackgroundHepatitis 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.MethodsIndividuals 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.ResultsA 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.ConclusionsThe 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.
Highlights
Hepatitis C virus (HCV) infection is a public health issue for which an effective universal screening method is urgently needed
Oral fluid samples from all participants were tested for HCV antibody using the Well oral anti-HCV assay, and blood samples were collected for serum HCV antibody detection as reference data
All participants were divided into three groups according to their primary disease history: 486 in the HCV infection group, 108 in the nonHCV-related liver disease group, and 585 in the healthy control group
Summary
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. Hepatitis C virus (HCV) infection is highly prevalent and a growing public health problem worldwide, especially in low- and middle-income areas. According to the World Health Organization (WHO), the prevalence of HCV infection ranges from 0.5–2.3%, and approximately 71 million people had chronic HCV infection in 2016. HCV-infected individuals develop an immune response to the virus, but the virus changes during replication and escapes, leaving 55–85% of patients with chronic infection [1]. Liu et al Virology Journal (2020) 17:14
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