What type of study is this?

This is a Human Clinical Trial study.

What question did this study set out to answer?

This research aims to evaluate the performance of the Xpert HCV test using fingerstick blood samples.

March 15, 2026Clinical Infectious Diseases1 citationsOpen Access

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

JHJennifer R. HavensUniversity of Kentucky SFShelly-Ann Fluker JSJonathan SchimmelMount Sinai Hospital

Key Points

This research aims to evaluate the performance of the Xpert HCV test using fingerstick blood samples.
Prospective observational study design
Conducted at CLIA-waived sites in the United States
Participants included individuals at risk for HCV infection
Xpert HCV test demonstrated high sensitivity and specificity
Test was acceptable for detecting HCV RNA in fingerstick blood
Findings suggest suitability for use in clinical practice

Abstract

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.

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

Key Points

Abstract

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