Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid (HIVOF)
This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral fluids.
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids|
- Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity [ Time Frame: 1 to 3 days ] [ Designated as safety issue: No ]Known HIV status determined clinically or serologically. HIV reactivity for all 100 samples determined first by licensed EIA and then confirmed with Western Blot and/or NAT testing.
- The Effectiveness of MPC and Chembio Oral Fluid Collection Devices [ Time Frame: 1-3 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
oral fluid samples and venous blood
|Study Start Date:||March 2008|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
The objective of this study is to evaluate the feasibility of using fresh oral fluid specimens, from known HIV-positive individuals, to test for HIV-1 antibodies using both the DPP HIV 1/2 and HIV 1/2 STAT-PAK tests. Two oral fluid collection devices will be used and compared (MPC and Chembio collection devices) and the results obtained from oral fluids will be compared with those obtained from whole blood and plasma using paired samples from the same participants. The comparison between oral fluid, whole blood and plasma will be made in both Chembio devices (HIV 1/2 STAT-PAK and DPP HIV 1/2).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636220
|United States, Maryland|
|Evelyn Jordan Center, University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Niel Constantine, PhD||University of Maryland|