Chembio Diagnostics, Inc., a leader in point-of-care diagnostic tests for infectious diseases, reported that data from a study evaluating performance characteristics (sensitivity and specificity) of the Company's patented Dual Path Platform (DPP(R)) rapid point-of-care (POC) test for syphilis was recently published online in Clinical Infectious Diseases and is expected to be published in the upcoming print edition. DPP(R) Syphilis Screen and Confirm is the first dual non-treponemal (screen for infection) and treponemal (confirms an active syphilis infection if non-treponemal is reactive) POC syphilis test that permits the simultaneous yet separate detection of both markers at the POC. The study authors concluded that DPP(R) Syphilis Screen and Confirm demonstrated good sensitivity and specificity in detecting treponemal and non-treponemal antibodies in three kinds of blood specimens. The complete article, "A dual point-of-care test shows good performance in simultaneously detecting nontreponemal and treponemal antibodies in patients with syphilis -- A multi-site evaluation study in China," can be accessed online at http://cid.oxfordjournals.org/content/early/2012/10/29/cid.cis928.abstract.
The study was supported by a grant from the Rapid Syphilis Test Introduction Project (UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases A70577 through a grant from the Bill & Melinda Gates Foundation).
Lawrence Siebert, Chembio's Chief Executive Officer, noted, "These data independently confirm the high sensitivity and specificity of our DPP(R) Syphilis Screen and Confirm rapid assay in patients with syphilis. The simultaneous detection of treponemal and non-treponemal antibodies offers the opportunity to increase coverage of syphilis screening and treatment. Currently, there is no single FDA-approved point-of-care test for syphilis that differentiates between active and past, or previously treated cases, and there continues to be a substantial interest in this product by public health groups in the United States and abroad."
According to the U.S. Centers for Disease Control and Prevention (CDC), "The use of only one type of serologic test is insufficient for diagnosis because each type of test has limitations, including the possibility of false-positive test results in persons without syphilis. False-positive nontreponemal test results can be associated with various medical conditions unrelated to syphilis, including autoimmune conditions, older age and injection-drug use; therefore, persons with a reactive nontreponemal test should receive a treponemal test to confirm the diagnosis of syphilis."
Mr. Siebert added, "We believe these positive data will be helpful in supporting our U.S. regulatory filing for DPP Syphilis Screen and Confirm, for which we are pursuing a de novo 510(k) regulatory pathway with the U.S. Food and Drug Administration (FDA). We are in discussion with the FDA to review these and other data and then to re-initiate clinical trials and submit our application by the middle of 2013."
According to the CDC, syphilis is a sexually transmitted disease caused by the bacterium Treponema pallidum. Syphilis can cause long-term complications and/or death if not adequately treated. In 2010 there were 45,834 new cases of syphilis in the U.S., of which, 13,774 were primary and secondary syphilis, the earliest and most transmissible stages of syphilis. The World Health Organization estimated that 11 million new cases of syphilis occurred in adults in 2005, the majority of them in developing countries.
The study was supported by a grant from the Rapid Syphilis Test Introduction Project (UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases A70577 through a grant from the Bill & Melinda Gates Foundation).
Lawrence Siebert, Chembio's Chief Executive Officer, noted, "These data independently confirm the high sensitivity and specificity of our DPP(R) Syphilis Screen and Confirm rapid assay in patients with syphilis. The simultaneous detection of treponemal and non-treponemal antibodies offers the opportunity to increase coverage of syphilis screening and treatment. Currently, there is no single FDA-approved point-of-care test for syphilis that differentiates between active and past, or previously treated cases, and there continues to be a substantial interest in this product by public health groups in the United States and abroad."
According to the U.S. Centers for Disease Control and Prevention (CDC), "The use of only one type of serologic test is insufficient for diagnosis because each type of test has limitations, including the possibility of false-positive test results in persons without syphilis. False-positive nontreponemal test results can be associated with various medical conditions unrelated to syphilis, including autoimmune conditions, older age and injection-drug use; therefore, persons with a reactive nontreponemal test should receive a treponemal test to confirm the diagnosis of syphilis."
Mr. Siebert added, "We believe these positive data will be helpful in supporting our U.S. regulatory filing for DPP Syphilis Screen and Confirm, for which we are pursuing a de novo 510(k) regulatory pathway with the U.S. Food and Drug Administration (FDA). We are in discussion with the FDA to review these and other data and then to re-initiate clinical trials and submit our application by the middle of 2013."
According to the CDC, syphilis is a sexually transmitted disease caused by the bacterium Treponema pallidum. Syphilis can cause long-term complications and/or death if not adequately treated. In 2010 there were 45,834 new cases of syphilis in the U.S., of which, 13,774 were primary and secondary syphilis, the earliest and most transmissible stages of syphilis. The World Health Organization estimated that 11 million new cases of syphilis occurred in adults in 2005, the majority of them in developing countries.