Rapid POC Diagnostic Test for Syphilis Could Produce Results in Under 20 Minutes

Syphilis infections continue to be a significant health problem and are particularly threatening in high-risk groups and in people who are pregnant, where congenital syphilis can severely affect pregnancy outcome and infant morbidity. According to the Centers for Disease Control and Prevention (CDC), the rate of primary and secondary syphilis (the most infectious stages of the disease) has increased almost every year since the historic low in 2001–2002, increasing 25.4% during 2020–2021, according to preliminary data. The timely identification and treatment of syphilis can decrease the transmission to others and result in better patient outcomes. Serologic tests are currently available in clinical laboratories for the detection of active syphilis, which require shipping samples to perform tests of moderate or high complexity. There is no rapid point-of-care test currently available to accomplish both screening and confirmation of active syphilis. Now, 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.

Chembio Diagnostics, Inc. (Hauppauge, NY, USA) has been awarded a USD 3.2 million contract from the CDC for the development and clinical validation of a rapid point-of-care (POC) diagnostic test for syphilis. Chembio will undertake to develop a syphilis test and confirm assay based on its Dual Path Platform (DPP) technology and proprietary DPP Micro Reader II. The assay will be intended to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies. The test should require only 10 µL of fingerstick blood, serum, or plasma and produce results in under 20 minutes.

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. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.

Additionally, Chembio has previous experience in the field of rapid syphilis diagnostics through its successful development, validation, and commercialization of DPP HIV-Syphilis. The Chembio DPP HIV-Syphilis Assay is a rapid serologic test for the detection of antibodies to HIV and/or the causative agent of syphilis, Treponema pallidum. Additionally, Chembio has worked to develop a DPP Syphilis Screen and Confirm test, using a CDC licensed reagent with improved liposomal preparation on the nontreponemal test line.

“We are excited to continue expanding our core sexually transmitted disease portfolio with the syphilis screen and confirm assay,” said Javan Esfandiari, Chembio’s Chief Science and Technology Officer. “We look forward to developing a highly sensitive and highly specific test that will potentially enable physicians to diagnose and treat active syphilis in a timely manner. Early and reliable diagnosis and timely treatment can prevent transmission of syphilis as well as the development of severe complications. We are honored to have been selected by the CDC for this award.”

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Chembio Diagnostics, Inc.