Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid (HIVOF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636220
Recruitment Status : Completed
First Posted : March 14, 2008
Results First Posted : February 15, 2010
Last Update Posted : August 17, 2015
University of Maryland
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.

March 10, 2008
March 14, 2008
January 8, 2009
February 15, 2010
August 17, 2015
March 2008
July 2008   (Final data collection date for primary outcome measure)
Number of Fresh Oral Fluid Samples With Known HIV (+) Status and HIV Reactivity [ Time Frame: 1 to 3 days ]
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 DPP HIV test and HIV Stat Pak tests will provide a 100% agreement with known HIV(+) status using fresh oral fluid samples [ Time Frame: 1 to 3 days ]
Complete list of historical versions of study NCT00636220 on Archive Site
The Effectiveness of MPC and Chembio Oral Fluid Collection Devices [ Time Frame: 1-3 ]
Compare the effectiveness of MPC and Chembio Oral Fluid collection devices [ Time Frame: 1-3 ]
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Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid
Evaluation of the DPP HIV Test With Reader and the HIV 1/2 Stat-Pak Test Using Oral Fluids
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).
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Retention:   Samples Without DNA
oral fluid samples and venous blood
Non-Probability Sample
The study population consists of 100 participants with known (clinically or serologically) confirmed HIV infection. The participants, recruited by the staff of the Laboratory of Vial Diagnostics from the Evelyn Jordan Center, may be males or females (including pregnant women) at least 12 years of age from any ethnic and racial background.
HIV Infections
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A, Observational
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2008
July 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants with known HIV infection who are willing to participate in the study and who sign an informed consent (or assent), will be included in the study.
  • Patients on HAART treatment for HIV will be included, but this information as well as the dates (duration) of treatment will be obtained through the interview of study participants; a medical record review is not necessary or required. The study participant's responses will be recorded by study staff on a Data Collection Form.
  • Patients with immunosuppressive conditions other than HIV will be included if available, but will be limited to < 25% of the total test population. Immunosuppression will also be assessed through interview of study participants and/or through verbal confirmation by the treating physician; a medical record/chart review is not required.
  • Patients must be willing to undergo venipuncture to donate one tube of EDTA whole blood (not more than 10cc), and to provide three oral fluid samples.

Exclusion Criteria:

  • Patients who do not consent, withdraw consent, or for whom the investigator determines that venipuncture or gum swabbing may create a health risk will be excluded from the study.
  • Participants who have been enrolled in HIV vaccine studies will be excluded from the study. This will be ascertained through interview of study participants.
  • Participants who have been enrolled once in this study will be excluded from repeat enrollment.
  • Participants must not have introduced any substance into their oral cavity (gum, food, beverage, candy, lozenges, mouthwash, etc.) for 30 minutes prior to providing an oral fluid sample. This will be ascertained through interview of study participants.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
UMB Protocol # H-29110
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Chembio Diagnostic Systems, Inc.
Chembio Diagnostic Systems, Inc.
University of Maryland
Principal Investigator: Niel Constantine, PhD University of Maryland
Chembio Diagnostic Systems, Inc.
July 2015