Trabajo

DPP SYPHILIS
®

SCREEN & CONFIRM

The Only Assay to Detect Both Disease Markers Simply at the Point of Care A rapid assay for the
detection of non-treponemal and treponemal antibodies tosyphilis in whole blood (venous or fingerstick), serum or plasma
FDA Clearance & CLIA waiver anticipated 2010 No Return Visits for 2nd Test Needed Enables treatment at Point of Care Optional PortableReader Available

Chembio has developed the first dual nontreponemal & treponemal POC syphilis test. Utilizing Chembio’s patented Dual Path Platform technology, DPP® Syphilis Screen & Confirm permits thesimultaneous yet separate detection of both markers at the point of care. DPP® Syphilis Screen & Confirm provides the most conclusive evidence, at the point of care, of active, untreated disease ascompared with current methods, thereby enabling diagnosis and treatment in a single visit to a clinic. The test, which will be eligible for a CLIA waiver, therefore represents a considerable advance indiagnosis as well as in time-to-result and ease of use.

The rate of primary and secondary (P&S) syphilis reported in the United States increased during 2000-2007. In 2007, P&S syphilis casesreported to the CDC increased 17.5% and the rate of P&S syphilis in the United States was 15.2% higher in 2007 (3.8 cases per 100,0000) than 2006 (3.3 cases per 100,000). Syphilis remains a significantglobal public health problem with WHO estimating 12 million new cases of the disease worldwide each year, including 100,000 per year in the UnitedStates and 140,000 per year in Western Europe. Standarddiagnosis of syphilis employs two separate central laboratory-based serologic tests, namely a nontreponemal screening test (RPR, VDRL) followed by a more specific confirmatory treponemal assay.Internal Studies: DPP® Syphilis Screen & Confirm Treponemal assay component has a sensitivity of 97% (32/33) and a specificity of 92% (24/26). The Non-Treponemal assay component has a sensitivity of...