Status:
UNKNOWN
Multicenter Performance Study of TriQuik Invitro Diagnostic Device
Lead Sponsor:
Genlantis Diagnostics
Collaborating Sponsors:
Northwestern University
Conditions:
To Demonstrate Clinical Performance of the TriQuik Invitro Diagnostic Device
Eligibility:
All Genders
18+ years
Brief Summary
This prospective and historical clinical study is designed to test the performance of the Genlantis TriQuik test kit (Cassette). The primary goal is to establish the sensitivity and specificity (i.e. ...
Detailed Description
Study Objective To demonstrate clinical performance of the TriQuik Invitro Diagnostic device. Measurement Methodology Whole blood samples are collected by fingerstick. Samples should be tested immedi...
Eligibility Criteria
Inclusion
- a documented medical history of HIV, HBV or HCV. 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 or HCV 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
- 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.
- \-
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05293821
Start Date
April 1 2023
End Date
November 1 2023
Last Update
January 13 2023
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