Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Performance Evaluation of the Xpert® HCV Test on Fingerstick Blood in a Prospective Observational Clinical Study at CLIA-Waived Sites in the United States.
Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06508996 (Clinical Evaluation of the Xpert® HCV Test on the GeneXpert® Xpress System), which is not on this map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Evaluation of the Xpert® HCV Test on the GeneXpert® Xpress System
Who cites it
2 citing papers in PubMed.
- A Turning Point for Hepatitis C Care: Point-of-Care Hepatitis C Virus RNA Authorization as a Critical First Step Toward Integrated Test-and-Treat Models in the United States.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Article
- More than a drop of blood: the paradigm shift of a large-volume capillary sample for point-of-care clinical diagnostics.Journal of clinical microbiology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
Abstract
backgroundA 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.
methodsParticipants 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.
resultsParticipants (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.
conclusionsData 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).
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.