Chembio Diagnostics, Inc. announced receipt of a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the DPP HIV-Syphilis System. Chembio's DPP HIV-Syphilis System assists clinicians in diagnosing both HIV and syphilis while patients are still under care at the testing location. The DPP HIV-Syphilis System is a multiplex, single-use, 15-minute test that is designed, in combination with Chembio's Micro Reader analyzer, to simultaneously detect antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis.

The test uses a small, 10-microliter sample of fingerstick whole blood, venous whole blood, or plasma. The DPP HIV-Syphilis System is highly sensitive and specific, has a built-in procedural control, can be stored at room temperature, and has a 24-month shelf life.