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Point-of-Care Syphilis Test Developed

Tuesday July 21, 2009
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The U.S. Centers for Disease Control and Prevention, in collaboration with Chembio Diagnostic Systems Inc., has developed a point-of-care test for syphilis that is expected to receive FDA clearance and CLIA waiver by summer of 2010. The test, called the DPP Syphilis Screen & Confirm, uses as small as a 5 ml sample of whole blood from a finger stick and can be read on a handheld reader within 15 minutes.

Traditional serologic testing is based on a two-step process of identifying antibodies to a non-treponemal marker of infection (RPR and/or VDRL) followed by a reflex test to a true T. pallidum specific antibody (FTA-ABS and/or TP-PA). While rapid diagnostic assays for the treponemal-specific antibodies exist, none are available in the U.S. and none are for the non-treponemal (cardiolipin) antibodies. Chembio’s product incorporates its patented DPP technology, enabling direct binding between the sample and the two markers (Trep. and N. Trep) in two diagnostic strips located on one assay tray. The test also combines optional point-of-care readers, which measure the reflectance of individual test lines and results in less subjectivity in the reading of the test, particularly in settings with poor lighting.

In 2007, primary and secondary syphilis cases reported to the CDC increased 17.5% and the rate of syphilis in the United States was 15.2% higher in 2007 (3.8 cases per 100,000) than in 2006 (3.3 cases per 100,000).

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