The Centers for Disease Control and Prevention (CDC) has awarded $3.2 million to Chembio Diagnostics for the development and validation of a point-of-care (POC) diagnostic test for active syphilis, the firm said Tuesday.
Under the contract, Chembio will develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and DPP Micro Reader II. The assay will be designed to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies.
The test should require only 10 uL of fingerstick blood, serum, or plasma and should produce results in less than 20 minutes, Chembio said.
The firm noted that serologic tests are currently available in clinical laboratories for the detection of active syphilis. These laboratory-based tests require shipping samples to perform tests of moderate or high complexity.
However, there is no rapid point-of-care test currently available to accomplish both screening and confirmation of active syphilis, the firm said, adding that 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 U.S.
