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

Chembio Diagnostic Systems, Inc.2,808 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,808

Conditions

HIV Infections

Interventions

In Vitro Diagnostic DeviceDEVICE

For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (5)

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

Outcomes

Primary Outcomes

The device detects HIV-1 antibodies in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant), oral fluid, serum and plasma (with EDTA or heparin anticoagulant).

Time frame: 20 minutes

Secondary Outcomes

The device provides a qualitative screen for the detection of antibodies to HIV-1 compared to an FDA approved HIV-1/2 EIA, with sensitivity and specificity equal to or greater than 98% at the lower 95% confidence interval boundary.

Time frame: 20 minutes

Data from ClinicalTrials.gov

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