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

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).

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.