Independent assessment of a point of care HCV RNA test by laboratory analytical testing and a prospective field study in the U.S Article Swipe
Lesley Miller
,
Anuradha Rao
,
Karlyn Tunnell
,
Yun F. Wang
,
Richard Parsons
,
Kaleb McLendon
,
Leda Bassit
,
Madhukar S. Patel
,
Heather B. Bowers
,
Courtney Sabino
,
Thanuja Ramachandra
,
Fahad Saeed
,
Raymond F. Schinazi
,
Wilbur A. Lam
,
Julie Sullivan
,
Shelly‐Ann Fluker
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1371/journal.pone.0324088
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1371/journal.pone.0324088
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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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1371/journal.pone.0324088
- OA Status
- gold
- Cited By
- 1
- References
- 19
- Related Works
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- OpenAlex ID
- https://openalex.org/W4412560499
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4412560499Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1371/journal.pone.0324088Digital Object Identifier
- Title
-
Independent assessment of a point of care HCV RNA test by laboratory analytical testing and a prospective field study in the U.SWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
-
2025Year of publication
- Publication date
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2025-07-22Full publication date if available
- Authors
-
Lesley Miller, Anuradha Rao, Karlyn Tunnell, Yun F. Wang, Richard Parsons, Kaleb McLendon, Leda Bassit, Madhukar S. Patel, Heather B. Bowers, Courtney Sabino, Thanuja Ramachandra, Fahad Saeed, Raymond F. Schinazi, Wilbur A. Lam, Julie Sullivan, Shelly‐Ann FlukerList of authors in order
- Landing page
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https://doi.org/10.1371/journal.pone.0324088Publisher landing page
- Open access
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YesWhether a free full text is available
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-
goldOpen access status per OpenAlex
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https://doi.org/10.1371/journal.pone.0324088Direct OA link when available
- Concepts
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Fingerstick, Medicine, Point-of-care testing, Point of care, Prospective cohort study, Hepatitis C, Internal medicine, Virology, Immunology, Pathology, Diabetes mellitus, EndocrinologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
1Total citation count in OpenAlex
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2025: 1Per-year citation counts (last 5 years)
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19Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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