Status:
COMPLETED
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
Lead Sponsor:
MedMira Laboratories Inc.
Conditions:
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined ...
Detailed Description
This clinical trial is a multi-center study to assess the performance characteristics of a rapid in vitro diagnostic assay, the Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4). Specifically, the objec...
Eligibility Criteria
Inclusion
- All subjects must be at least 18 years of age, able to sign consent form, complete the risk assessment questionnaire, and provide the required blood samples: fingerstick sample (1 drop), venous whole blood sample (1 K2 EDTA tube).
- Population 1 - Individuals at risk of HIV infection (n ≥ 500) Subjects must meet have at least one risk factor for infection with HIV
- Population 2 - Known HIV-1 positive individuals (n ≥ 500) Subjects must be a known HIV-positive individual (previous positive HIV test result)
- Population 3 - Individuals at low risk of HIV infection (n ≥ 500) Subjects must not have any risk factors for infection with HIV
Exclusion
- Subjects do not meet inclusion criteria
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
1649 Patients enrolled
Trial Details
Trial ID
NCT02190578
Start Date
July 1 2014
End Date
March 1 2015
Last Update
April 24 2015
Active Locations (4)
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1
Preventive Medicine, University of Southern California (Los Angeles)
Los Angeles, California, United States, 90007
2
Therafirst Medical Center
Fort Lauderdale, Florida, United States, 33308
3
New York City Department of Health and Mental Hygiene
Queens, New York, United States, 11101
4
Biological Specialty Corporation
Reading, Pennsylvania, United States, 19602