ArticlePloS one2025
Independent assessment of a point of care HCV RNA test by laboratory analytical testing and a prospective field study in the U.S.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Informing the Equitable Implementation of Hepatitis C Interventions: Cost-Effectiveness Modeling in Rural Populations of People Who Inject Drugs.PharmacoEconomics · 2026Article
- Performance Evaluation of the Xpert® HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Observational
- A Turning Point for Hepatitis C Care: Point-of-Care Hepatitis C Virus RNA Authorization as a Critical First Step Toward Integrated Test-and-Treat Models in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- More than a drop of blood: the paradigm shift of a large-volume capillary sample for point-of-care clinical diagnostics.Journal of clinical microbiology · 2026Review
- Independent Testing to Accelerate the Development of Lateral Flow Assays for Influenza A, Influenza B and SARS-COV-2.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Improvements in HCV testing, including Point of Care (POC) HCV RNA tests, are necessary to eliminate HCV. With this goal in mind, we established methods to collect capillary whole blood (CWB) via fingerstick, ensured its stability in a microtainer, and determined limit of detection (LoD) for various HCV genotypes. Next, we conducted a prospective study where CWB samples were collected from a cohort of 109 adult subjects at a safety-net hospital and tested for HCV RNA using the Xpert® HCV test on the GeneXpert® Xpress system and the cobas® HCV platform. We consistently obtained 250 μl CWB which was stable for up to 5 hours in the microtainer. Laboratory LoD studies demonstrated that the Xpert® HCV test could detect most HCV genotypes to <100 IU/ml in CWB. In the prospective clinical study, 89 subjects (82%) with valid Xpert® and cobas® HCV comparator results were analyzed. Using Xpert®, 16 out of 89 (18%) subjects had detectable HCV RNA and 73 (82%) had undetectable HCV RNA. Using cobas, 17 out of 89 (19%) participants had detectable HCV RNA, and 72 (81%) were undetectable. One sample was detectable on cobas but not Xpert®, yielding a sensitivity of 94% and specificity of 100%. This study demonstrates the feasibility of HCV RNA testing at POC using CWB obtained by fingerstick and provides preliminary data on the accuracy of the Xpert® HCV test performed by untrained operators in a CLIA-waived setting.
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