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

Details

• Alternative Title:
  Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America, 2026, v. 83, no. 1: Performance Evaluation of the Xpert® HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States.
• Journal Article:
  Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America
• Personal Author:
  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.
• Description:
  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.
  
  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 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.
  
  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).
• Content Notes:
  Author manuscript
• Subjects:
  • Humans
  • Hepatitis C
  • Prospective Studies
  • United States
  • Female
  • Hepacivirus
  • Male
  • Adult
  • RNA, Viral
  • Middle Aged
  More +
• Keywords:
  • hepatitis C
  • viral RNA
  • point-of-care
• Source:
  Clinical Infectious Diseases : An Official Publication of the Infectious Diseases Society of America, 2026, v. 83, no. 1
• DOI:
  https://doi.org/10.1093/cid/ciag173
• ISSN:
  1058-4838 ; 1537-6591
• Pubmed ID:
  41823658
• Pubmed Central ID:
  PMC13320264
• Document Type:
  Text
• Funding:
  75N92022F00004/NH/NIH HHSUnited States/ ; 75N92022D00014/NH/NIH HHSUnited States/ ; 75N94023F00001/HD/NICHD NIH HHSUnited States/ ; 75N92022D00015/OD/NIH HHSUnited States/ ; 75N92022D00014/HL/NHLBI NIH HHSUnited States/ ; 75N92023F00001/NH/NIH HHSUnited States/ ; FD/FDA HHSUnited States/ ; 75N92022F00003/NH/NIH HHSUnited States/ ; 75N92022D00013/OD/NIH HHSUnited States/ ; Centers for Disease Control (CDC)/ ; U54 EB007958/EB/NIBIB NIH HHSUnited States/ ; UM1 AI068613/AI/NIAID NIH HHSUnited States/
• Genre:
  Journal Article
• Pages in Document:
  e71-e78 (17 pdf pages)
• Volume:
  83
• Issue:
  1
• Download URL:
  https://stacks.cdc.gov/view/cdc/260742/cdc_260742_DS1.pdf
• File Type:
  [PDF - 505.98 KB]
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:6fb33cd9f59aa81f5a35c83520f0db1492bf5ddf7ed3561db46e92c28f99e80d3448048ee16e3ae1ac47b243423060a87bd17cc307d3adbc802170015fd7842b