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

Abstract

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. 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. 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). 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.