Performance Evaluation of the Xpert® HCV test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States.
| Title: | Performance Evaluation of the Xpert® HCV test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States. |
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| Authors: | Havens JR; University of Kentucky College of Medicine, Lexington, KY, USA.; Fluker SA; Emory University School of Medicine, Atlanta, GA, USA.; Schimmel J; Mount Sinai Icahn School of Medicine, New York, NY, USA.; McCrary LM; Washington University School of Medicine, St. Louis, MO, USA.; Miller LS; Emory University School of Medicine, Atlanta, GA, USA.; Udo T; College of Integrated Health Sciences, University at Albany, Albany, NY, USA.; Manabe YC; Johns Hopkins University School of Medicine, Baltimore, MD, USA.; Luetkemeyer A; University of California San Francisco, San Francisco, CA, USA.; Burkholder G; University of Alabama Birmingham Heersink School of Medicine, Birmingham, AL, USA.; Moon AM; University of North Carolina School of Medicine, Chapel Hill, NC, USA.; Chastain CA; Vanderbilt University Medical Center, Nashville, TN, USA.; Price JC; University of San Francisco School of Medicine, San Francisco, CA, USA.; Cafardi J; The Christ Hospital, Cincinnati, OH, USA.; Gallegos-Orozco JF; University of Utah School of Medicine, Salt Lake City, UT, USA.; Young BA; University of Utah School of Medicine, Salt Lake City, UT, USA.; Young J; TriCore Reference Laboratories, Albuquerque, NM, USA.; Aparicio C; CLAS Automation, Inc., Miami, FL, USA.; Song Y; Cepheid, Sunnyvale, California, USA.; Lai E; PharmaDx, LLC, San Diego, California, USA.; Louw GE; Cepheid, Sunnyvale, California, USA. |
| Source: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2026 Mar 13. Date of Electronic Publication: 2026 Mar 13. |
| Publication Model: | Ahead of Print |
| Publication Type: | Journal Article |
| Language: | English |
| Journal Info: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| Imprint Name(s): | Publication: Jan. 2011- : Oxford : Oxford University Press; Original Publication: Chicago, IL : The University of Chicago Press, c1992- |
| Abstract: | Background: A major barrier to hepatitis C virus (HCV) elimination in the United States (U.S.) is the lack of a point-of-care (POC) test to confirm the presence of HCV RNA. The purpose of this clinical trial was to evaluate the performance of the Xpert® HCV test at CLIA-waived sites in the U.S.; Methods: Participants at risk and/or with signs/symptoms of HCV infection provided fingerstick blood that was tested on the Xpert® HCV test and venous blood tested using the cobas® HCV and Elecsys® Anti-HCV II tests. Fingerstick blood was collected at CLIA-waived sites by individuals self-trained on collection procedures.; Results: 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®, 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® HCV test demonstrated a positive percent agreement (PPA) of 93.4% (95% CI: 87.6-96.6) and a negative percent agreement (NPA) of 99.8% (95% CI: 99.2-99.9) relative to the patient infected status (PIS).; Conclusions: Data from this clinical trial showed that the Xpert® 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.; (© The Author(s) 2026. Published by Oxford University Press on behalf of Infectious Diseases Society of America.) |
| Grant Information: | U54 EB007958 United States EB NIBIB NIH HHS |
| Contributed Indexing: | Keywords: hepatitis C; point-of-care; viral RNA |
| Entry Date(s): | Date Created: 20260313 Latest Revision: 20260412 |
| Update Code: | 20260412 |
| DOI: | 10.1093/cid/ciag173 |
| PMID: | 41823658 |
| Database: | MEDLINE |
Journal Article