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

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.

Inclusion Criteria: * 18 years of age or older * Operator/study staff must be able to obtain data to complete the participant's Enrollment Questionnaire * Participant can provide a history of HCV treatment if applicable * Participant is able and willing to give informed consent * Participant is willing and able to provide the required fingerstick and venous whole blood samples * Participant must meet at least one of the following categories: 1. Having signs or symptoms of hepatitis, or 2. Are at risk of HCV infection Exclusion Criteria: * Participant unwilling or unable to provide the required volume of fingerstick and venous whole blood * Participant unwilling or unable to provide HCV treatment history, if applicable * Participant is already enrolled and participating in another clinical study that would interfere with the study activities and/or data integrity * Known bleeding disorder or any other medical condition that, in the opinion of the Investigator or Operator, contraindicates fingerstick or venipuncture procedures * Any other conditions which, in the opinion of the Investigator or Operator, would make the participant unsuitable or unsafe for enrollment or could interfere with the completion of study assessments