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.
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).
Study Type
OBSERVATIONAL
Enrollment
101
Evelyn Jordan Center, University of Maryland
Baltimore, Maryland, United States
Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity
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.
Time frame: 1 to 3 days
The Effectiveness of MPC and Chembio Oral Fluid Collection Devices
Time frame: 1-3
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