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

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.

Inclusion Criteria:

• Must be at least 2 years of age (no upper age limit).
• Must be willing and able to receive post-test counseling, if applicable.
• Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
• Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion Criteria:

• Am in a life threatening condition at the time of enrollment
• Have a suppressed immune systems (i.e. transplant patients, individuals diagnosed with non-HIV immunosuppressive illness, etc.).
• Have participated or are participating in a clinical trial for an HIV vaccine.
• Have previously participated in this clinical trial.