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Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test

NCT02190578 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1649

Last updated 2015-04-24

No results posted yet for this study

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 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.

Conditions

  • HIV Infections

Interventions

DEVICE

Reveal G4

All subjects tested with the investigational device, Reveal G4, plus with an algorithm of approved assays for HIV.

Sponsors & Collaborators

  • MedMira Laboratories Inc.

    lead INDUSTRY

Principal Investigators

  • Fabienne Laraque, MD · New York City Department of Health and Mental Hygiene

  • Peter Kerndt, MD · University of Southern California - Los Angeles

  • Cheryl Berne, MD · Biological Specialties Corporation

  • Anthony LaMarca, MD · Therafirst Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02190578 on ClinicalTrials.gov