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NOT YET RECRUITING
NCT07904416
NA

Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use

Sponsor: bioLytical Laboratories

View on ClinicalTrials.gov

Summary

multicenter prospective study to evaluate the clinical performance, usability and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with signs or symptoms of hepatitis or participants at risk for hepatitis C infection, by untrained operators at CLIA Waived settings.

Official title: A Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use in Individuals at Risk for HCV Infection or Presenting With Signs and Symptoms of HCV Infection by Untrained Operators in the United States

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

388

Start Date

2026-11-01

Completion Date

2027-07-01

Last Updated

2026-10-29

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

INSTI HCV Antibody Test

The INSTI® HCV Antibody test is a manual, rapid, flow-through immunoassay for the detection of HCV-specific antibodies. It is intended for use as an aid in the diagnosis of HCV infection in adults over 18 years of age.