ArticleVirology journal2020
Evaluation of a new point-of-care oral anti-HCV test for screening of hepatitis C virus infection.
Article in Virology journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 33 citations in OpenAlex.
- Ameliorative effects of HGF-overexpressed exosomes derived from ADMSCs on oxidative stress in hepatic fibrosis.Histology and histopathology · 2025Article
- Evaluating effectiveness and comparative costs of hepatitis C virus self-testing service delivery models in Vietnam: A cross-sectional study.PLOS global public health · 2025Article
- Hepatitis C virus care continuum: integrating point of care RNA assay and direct acting antivirals.EXCLI journal · 2025Article
- Review
- Quality Assurance for Hepatitis C Virus Point-of-Care Diagnostics in Sub-Saharan Africa.Diagnostics (Basel, Switzerland) · 2023Review
- Logarithmic confidence estimation of a ratio of binomial proportions for dependent populations.Journal of applied statistics · 2023Article
- Usability and acceptability of oral fluid hepatitis C self-testing among people who inject drugs in Coastal Kenya: a cross-sectional pilot study.BMC infectious diseases · 2022Article
- Morphological Changes in the Oral Mucous Membrane in Viral Hepatitis C Patients: A Cross-Sectional Study.International journal of environmental research and public health · 2022Article
- Article
- A Look Inside: Oral Sampling for Detection of Non-oral Infectious Diseases.Journal of clinical microbiology · 2021Article
- Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises.Diagnostics (Basel, Switzerland) · 2021Review
- Values and preferences for hepatitis C self-testing among people who inject drugs in Kyrgyzstan.BMC infectious diseases · 2021Article
- Usability and acceptability of self-testing for hepatitis C virus infection among the general population in the Nile Delta region of Egypt.BMC public health · 2021Observational
- A Lay-User Assessment of Hepatitis C Virus Self-Testing Device Usability and Interpretation in Johannesburg, South Africa.Diagnostics (Basel, Switzerland) · 2021Article
- Article
Corrections and comments
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Authors and funding
15 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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