Evaluation of the Performance of Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 Rapid Test

Completed

Conditions studied: HIV Infections

In brief

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® HIV 1/2 rapid test. The device is intended to qualitatively detect the presence of antibodies against HIV-1/2 in oral fluid, whole blood (capillary and venous), serum or plasma. This study will assess the DPP® HIV 1/2 Screen assay's ability to detect HIV-1.

Key facts

Study ID: NCT01032902
Run by: Chembio Diagnostic Systems, Inc.
People needed: 2808
Starts: 2010-01-01
Expected to finish: 2012-04-01
Last updated by the study team: 2012-04-30

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Must be at least 2 years of age (no upper age limit).
Must be willing and able to receive post-test counseling, if applicable.
Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
Must be able to sustain fingersticks and venipuncture from the arm or hand only.

You may not qualify if…

Am in a life threatening condition at the time of enrollment
Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
Have participated or are participating in a clinical trial for an HIV vaccine.
Have previously participated in this clinical trial.

Where it is running

Univeristy of California, San Diego — La Jolla, California, United States
Therafirst — Fort Lauderdale, Florida, United States
University of Maryland — Baltimore, Maryland, United States
St. Christopher's Hospital for Children/ Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
University of Texas HSC — Houston, Texas, United States

Full record on ClinicalTrials.gov

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