{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T01:21:12Z","timestamp":1784856072562,"version":"3.55.0"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T00:00:00Z","timestamp":1773360000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["75N92022D00015"],"award-info":[{"award-number":["75N92022D00015"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["75N92022F00003"],"award-info":[{"award-number":["75N92022F00003"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["75N92022D00013"],"award-info":[{"award-number":["75N92022D00013"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["75N92022F00004"],"award-info":[{"award-number":["75N92022F00004"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["75N92022D00014"],"award-info":[{"award-number":["75N92022D00014"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["75N92023F00001"],"award-info":[{"award-number":["75N92023F00001"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000030","name":"Centers for Disease Control","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000030","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100009210","name":"Food and Drug Administration","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009210","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>A major barrier to hepatitis C virus (HCV) elimination in the United States is the lack of a point-of-care test to confirm the presence of HCV RNA. The purpose of this clinical trial was to evaluate the performance of the Xpert\u00ae HCV test at CLIA-waived sites in the United States.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Participants at risk and\/or with signs\/symptoms of HCV infection provided fingerstick blood that was tested on the Xpert\u00ae HCV test and venous blood tested using the cobas\u00ae HCV and Elecsys\u00ae Anti-HCV II tests. Fingerstick blood was collected at CLIA-waived sites by individuals self-trained on collection procedures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Participants (N = 1279) were enrolled across 15 sites; 1015 (79.3%) were deemed eligible for further evaluation. Specimens from 985 (97.0%) participants with valid results for Xpert\u00ae, cobas and Elecsys were included in the performance analysis. The prevalence of HCV antibodies and HCV RNA was 34.6% and 12.4%, respectively. The Xpert\u00ae HCV test demonstrated a positive percent agreement of 93.4% (95% CI: 87.6\u201396.6) and a negative percent agreement of 99.8% (95% CI: 99.2\u201399.9) relative to the patient infected status.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Data from this clinical trial showed that the Xpert\u00ae HCV test was sensitive, specific, and acceptable for use to detect HCV RNA in human EDTA fingerstick blood from individuals at risk and\/or with signs\/symptoms of HCV infection.<\/jats:p>\n                    <jats:p>Clinical Trials Registration. This study, Pro0075996, was approved by Advarra IRB (Columbia, Maryland, 21044) and registered on ClinicalTrials.gov (NCT06508996).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag173","type":"journal-article","created":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T12:54:02Z","timestamp":1773233642000},"page":"e71-e78","source":"Crossref","is-referenced-by-count":1,"title":["Performance Evaluation of the Xpert\u00ae HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States"],"prefix":"10.1093","volume":"83","author":[{"given":"Jennifer R","family":"Havens","sequence":"first","affiliation":[{"name":"University of Kentucky College of Medicine Department of Behavioral Science, , Lexington, Kentucky 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Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0911-1578","authenticated-orcid":false,"given":"Anne","family":"Luetkemeyer","sequence":"additional","affiliation":[{"name":"University of California SanFrancisco Department of Medicine, , San Francisco, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Greer","family":"Burkholder","sequence":"additional","affiliation":[{"name":"University of Alabama Birmingham Heersink School of Medicine Department of Medicine, , Birmingham, Alabama ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7163-2062","authenticated-orcid":false,"given":"Andrew M","family":"Moon","sequence":"additional","affiliation":[{"name":"University of North Carolina School of Medicine Department of Medicine, , Chapel Hill, North Carolina 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