Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
Performance Evaluation of the Xpert® HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States.
СтатьяНаблюдательное исследованиеОценочное исследованиеПоддержка NIH: внешняя программаНазвание и аннотация: Перевод пока не подготовлен
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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, Louw Gail E
Аннотация
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).
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).