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NCT07904416
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
Conditions: HCV Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 388
Sponsor: bioLytical Laboratories
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07904416). StuddyBuddy aggregates publicly available trial information.