Performance Evaluation of the Xpert® HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States

Authors

• Jennifer R. Havens, University of KentuckyFollow
• Shelly Ann Fluker, Emory University
• Jonathan Schimmel, Icahn School of Medicine at Mount Sinai
• L. Madeline McCrary, Washington University School of Medicine in St. Louis
• Lesley S. Miller, Emory University
• Tomoko Udo, State University of New York
• Yukari C. Manabe, Johns Hopkins University School of Medicine
• Anne Luetkemeyer, University of California San Francisco
• Greer Burkholder, University of Alabama at Birmingham
• Andrew M. Moon, University of North Carolina at Chapel Hill
• Cody A. Chastain, Vanderbilt University
• Jennifer C. Price, University of SanFrancisco School of Medicine
• John Cafardi, Health Alliance
• Juan F. Gallegos-Orozco, University of Utah
• Brittany A. Young, University of Utah
• Jesse Young, University of Utah
• Carlos Aparicio, Inc.
• Yu Song, Danaher
• Eric Lai, LLC
• Gail E. Louw, Danaher

Abstract

Background: 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® HCV test at CLIA-waived sites in the United States. 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 of 93.4% (95% CI: 87.6–96.6) and a negative percent agreement of 99.8% (95% CI: 99.2–99.9) relative to the patient infected status. 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. Clinical Trials Registration. This study, Pro0075996, was approved by Advarra IRB (Columbia, Maryland, 21044) and registered on ClinicalTrials.gov (NCT06508996).

Document Type

Article

Publication Date

7-1-2026

Notes/Citation Information

Publisher Copyright: © The Author(s) 2026. Published by Oxford University Press on behalf of Infectious Diseases Society of America. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

Digital Object Identifier (DOI)

10.1093/cid/ciag173

Archival?

Archival

Repository Citation

Havens, Jennifer R.; Fluker, Shelly Ann; Schimmel, Jonathan; McCrary, L. Madeline; Miller, Lesley S.; Udo, Tomoko; Manabe, Yukari C.; Luetkemeyer, Anne; Burkholder, Greer; Moon, Andrew M.; Chastain, Cody A.; Price, Jennifer C.; Cafardi, John; Gallegos-Orozco, Juan F.; Young, Brittany A.; Young, Jesse; Aparicio, Carlos; Song, Yu; Lai, Eric; and Louw, Gail E., "Performance Evaluation of the Xpert® HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States" (2026). Epidemiology and Environmental Health Faculty Publications. 108.
https://uknowledge.uky.edu/epidemiology_facpub/108