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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
Sponsor: bioLytical Laboratories
Summary
A 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 trained operators at point of care (POC) settings. POC settings are locations where medical diagnostic testing is performed at or near the site of patient care.
Official title: A Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection by Trained Operators in the United States
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1660
Start Date
2026-11-01
Completion Date
2027-07-01
Last Updated
2026-10-29
Healthy Volunteers
Yes
Conditions
Interventions
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.