Chembio Diagnostics announce receipt of CLIA waiver for DPP HIV-Syphilis system

Chembio Diagnostics 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. "The DPP HIV-Syphilis System represents an exciting advancement in rapid testing for sexually transmitted infections. We are excited that the 200,000+ CLIA waived point-of-care testing sites in the U.S. now have access to the DPP HIV-Syphilis System where its use can help save lives and minimize the spread of both HIV and syphilis," said Richard Eberly, Chembio’s President and CEO. "Rapid HIV and syphilis combination testing is now even more important to community health as the U.S. Centers for Disease Control and Prevention’s most recent sexually transmitted disease surveillance data reports that STDs in the U.S. have reached all-time highs for the sixth consecutive year. Most importantly, the DPP HIV-Syphilis System offers actionable information to better manage two of the most critical threats posed by syphilis infections: the potentially lethal mother to child transmission and the increased risk of contracting HIV." 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.