Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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 by comparing the results with patient infected status for HIV-1 (human immunodeficiency virus type 1). The study will consist of a single one-hour visit, at which time blood samples will be collected and tested with the investigational device (Reveal G4) and FDA approved comparator assays for detection of HIV-1 antibodies.

Key facts

Study ID

NCT02190578

Run by

MedMira Laboratories Inc.

People needed

1649

Starts

2014-07-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects do not meet inclusion criteria

Where it is running

• Preventive Medicine, University of Southern California (Los Angeles) — Los Angeles, California, United States
• Therafirst Medical Center — Fort Lauderdale, Florida, United States
• New York City Department of Health and Mental Hygiene — Queens, New York, United States
• Biological Specialty Corporation — Reading, Pennsylvania, United States

Full record on ClinicalTrials.gov

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