NCT01032902

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

Study to Establish the Ability of the Chembio Diagnostics Systems, Inc. DPP HIV 1/2 Rapid Test to Qualitatively Detect the Presence of Antibodies Against HIV-1 in Oral Fluid, Whole Blood (Capillary and Venous), Serum and Plasma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,808 (actual)
• Sponsor: Chembio Diagnostic Systems, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DEVICE	In Vitro Diagnostic Device	For the detection of antibodies to HIV in serum, plasma, blood and oral fluid

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2009-12-16
• Last updated: 2012-04-30

Locations

5 sites across 1 country: United States