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Chembio Diagnostics Announces Approval of Zika, Dengue and Chikungunya Point-of-Care Multiplex Test by Brazil’s Health Regulatory Agency

Chembio Diagnostics, Inc., a leading point-of-care diagnostics company focused on infectious diseases, today announced the approval of its DPP Zika/Dengue/Chikungunya System by Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health regulatory agency, in collaboration with Bio-Manguinhos/Fiocruz.

Chembio’s DPP Zika/Dengue/Chikungunya multiplex test allows simultaneous and discrete detection of antibodies for both active (IgM) and prior exposure (IgG) to the Zika, dengue, and chikungunya viruses, which is important for both treatment and surveillance. The test is performed using a small (10µL) drop of fingertip blood and provides quantitative results in approximately 15 minutes when used with the company’s handheld DPP Micro Reader. An evaluation of the multiplex test by Brazil’s Instituto Nacional de Controle de Qualidade em Saúde (INCQS) demonstrated outstanding analytical performance using patient samples in this highly endemic region, with all six results yielding sensitivity between 95.2% - 100% and specificity between 96.6% - 100%.

“Brazil faces a complex epidemiological scenario, characterized by simultaneous circulation of three arboviruses - Zika, dengue, and chikungunya - all transmitted by the Aedes aegypti mosquito,” stated John Sperzel, Chembio’s Chief Executive Officer. “Co-circulation hampers clinical differential diagnoses, as those arboviruses share common signs and symptoms. This ANVISA approval paves the way for commercialization in Brazil, and we believe our multiplex test will be an important tool in combating these serious diseases.”

This ANVISA approval advances Chembio’s previously announced commercial agreement with Bio-Manguinhos, a Brazilian government agency and supplier of diagnostic products to Brazil’s Ministry of Health, to develop and supply high-quality, rapid diagnostic tests for Zika, dengue, and chikungunya using Chembio’s DPP technology platform.

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