NEW YORK – Chembio Diagnostics announced on Tuesday that it has received $3.2 million from the US Centers for Disease Control and Prevention to develop a rapid point-of-care test for syphilis.
The test will be intended to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies from fingerstick blood, serum, or plasma, with results provided in less than 20 minutes, Chembio said in a statement. The test and confirm assay will be based on the company's Dual Path Platform technology and its DPP Micro Reader II, an optical analyzer.
Hauppauge, New York-based Chembio's DPP platform allows eight tests to be run on a single patient sample and provides results in 15 to 20 minutes, it said.
"There is no rapid point-of-care test currently available to accomplish both screening and confirmation of active syphilis," Chembio said. "The development of such a test should allow for rapid diagnosis of an active infection and timely patient treatment, thus reducing the overall burden of syphilis in the US."
The firm's DPP HIV-Syphilis Assay, a rapid serologic test to detect antibodies to HIV and/or Treponema pallidum, the causative agent of syphilis, received premarket approval from the US Food and Drug Administration in 2020.