Multicenter Performance Study of QuadQuik Invitro Diagnostic Device

Status unconfirmed

Conditions studied: HIV Infections, Hepatitis C, Hepatitis B, Syphilis Infection

In brief

To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device

Key facts

Study ID

NCT05692505

Run by

Genlantis Diagnostics

People needed

200

Starts

2023-04-01

Expected to finish

2023-06-01

Last updated by the study team

2023-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).-

You may not qualify if…

• 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.-

Where it is running

• Genlantis Diagnostics — San Diego, California, United States

Full record on ClinicalTrials.gov

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