Under the agreement between FIOCRUZ and Chembio on 30 November 2010 they planned to cover two DPP Syphilis tests.
The first DPP Syphilis product now approved by ANVISA is a single parameter Treponemal test for the detection of antibodies specific to Syphilis.
The second product, Chembio’s DPP Syphilis Screen & Confirm Assay is a multiplex test that incorporates the Treponemal as well as a Non-Treponemal parameter, thereby better enabling the detection and differentiation of active infections from past infections in one rapid, point-of-care device.
Currently two separate complex clinical laboratory tests are performed in order to detect the presence of these two markers required to confirm an active syphilis infection.
An evaluation of this multiplex product was commenced during the first quarter in China in collaboration with the WHO, and the company is preparing for the initiation of US clinical trials in support of a Section 510(k) pre-market notification for this product.
The clinical trials are anticipated to begin next month.
