Chembio Diagnostics has received a Clinical Laboratory Improvement Amendments (CLIA) waiver from the U.S. Food and Drug Administration (FDA) for the DPP HIV-Syphilis System, the company announced on Friday.
As a result, more than 200,000 CLIA-waived point-of-care testing sites in the U.S. can now use the system to detect HIV and syphilis, Richard Eberly, Chembio’s president and CEO, said in a statement. Immunoassay Lab Test
“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 [STD] surveillance data reports that STDs in the U.S. have reached all-time highs for the sixth consecutive year,” he said. “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.”
Co-infection rates of HIV and syphilis are on the rise and individuals with an active syphilis infection have an estimated two- to five-fold increased risk of contracting HIV if exposed to that virus, Chembio noted, citing the U.S. Centers for Disease Control and Prevention (CDC).
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.
Inflammatory Marker The test uses a small, 10-microliter sample of fingerstick whole blood, venous whole blood, or plasma.