Chembio Diagnostics, a point-of-care diagnostics company focused on infectious diseases, announced the submission to the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DPP HIV-Syphilis System.

“We are pleased to communicate that our DPP HIV-Syphilis System has been submitted to FDA for CLIA waiver. Upon receipt of CLIA waiver, we believe this will represent a large step forward in rapid testing for sexually transmitted infections. We appreciate the collaboration with the FDA on this submission and look forward to continued dialog regarding our CLIA waiver application,” says Richard L. Eberly, Chembio’s president and CEO.

HIV & Syphilis

Co-infection rates of HIV and syphilis are on the rise, according to the CDC, and individuals with an active syphilis infection have an estimated two- to five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that untreated syphilis in pregnant women who contracted the disease during the four years prior to delivery can lead to infection of the fetus in up to 80% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing of women of childbearing age and treatment of infected pregnant women.

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 system is a multiplex, single-use, 15-minute test that is designed, in combination with our 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 Rapid Test Platform

Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests.