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# Chembio Expects HIV/Syphilis Approval in 2 Months
- URL: https://www.fdaweb.com/chembio-expects-hiv-syphilis-approval-in-2-months/
- Published: 2020-01-03T12:00:00.000Z
- Updated: 2026-09-14T15:57:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145753

Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System. The single-use, 15-minute screening test simultaneously detects antibodies to HIV Types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum. It uses a 10 microliter sample of fingerstick whole blood, venous whole blood, or plasma, according to the company. It also has a built-in procedural control, can be stored at room temperature, and has up to a 24-month shelf life.

The company says its clinical study, which included the prospective enrollment of over 2,500 subjects, demonstrated that the device met FDA-established performance requirements. It also says it provided additional requested studies, which included data on pregnant women.

According to Chembio, co-infection rates of HIV and syphilis are on the rise and those with an active syphilis infection have an estimated two-to-five-fold increased risk of contracting HIV if exposed to the virus. Further, it says about two million pregnancies annually are affected by mother-to-child-transmission of HIV and/or syphilis, resulting in high rates of stillbirth, spontaneous abortion, low birth weight, and perinatal death.