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

Completed

• Conditions: HIV Infections

• Registration Number: NCT01032902
• Lead Sponsor: Chembio Diagnostic Systems, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Study Start: 2010-01
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2808

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).	20 minutes

Secondary Outcome Measures

Name	Time	Method
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.	20 minutes

Trial Locations

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

University of Texas HSC; 🇺🇸 Houston, Texas, United States