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NCT05692505
Multicenter Performance Study of QuadQuik Invitro Diagnostic Device
Conditions: HIV Infections, Hepatitis C, Hepatitis B, Syphilis Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 200
Sponsor: Genlantis Diagnostics
Location: United States
Summary
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
Eligibility Criteria
Inclusion Criteria:a documented medical history of HIV, HBV, HCV or syphilis.
A combination of 2 or 3 conditions is acceptable.HbsAg patients need to have a HbsAg on file < 2 years.
HIV and HCV patients only need one antibody test in their medical chart.
no documented medical history of HIV, HBV, HCV or syphilis and are considered normal.Male or female subjects, ages ≥18 years.
Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).-Exclusion Criteria:Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.-
Source: ClinicalTrials.gov (NCT05692505). StuddyBuddy aggregates publicly available trial information.