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Chembio Diagnostics Gets Brazilian Regulatory Approval for POC Multiplex Flavivirus Test

NEW YORK (360Dx) – Chembio Diagnostics said today that it has received Brazilian health agency approval for its DPP Zika/Dengue/Chikungunya point-of-care system in collaboration with Bio-Manguinhos/Fiocruz, a Brazilian government agency and supplier of diagnostic products to the country's Ministry of Health.

The approval granted by Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health regulatory agency, advances Chembio’s previously announced commercial agreement with Bio-Manguinhos to develop and supply rapid diagnostic tests for the flaviviruses Zika, dengue, and chikungunya using Chembio’s DPP technology platform.

Chembio said that its DPP Zika/Dengue/Chikungunya multiplex test allows simultaneous and discrete detection of both active IgM antibodies and prior-exposure IgG antibodies to the Zika, dengue, and chikungunya viruses, which is important for both treatment and surveillance.

The company’s DPP technology, a chromatographic immunoassay, uses a drop of blood and provides results in around 15 minutes when it is used with Chembio's handheld DPP Micro Reader.

In a demonstration of its analytical performance using patient samples, the multiplex test yielded sensitivity between 95.2 percent and 100 percent as well as specificity between 96.6 percent and 100 percent, Chembio said.

In a statement John Sperzel, Chembio’s CEO, said that "Brazil faces a complex epidemiological scenario, characterized by simultaneous circulation of three arboviruses — Zika, dengue, and chikungunya —all transmitted by the Aedes aegypti mosquito."

Co-circulation hampers clinical differential diagnoses because these arboviruses share common signs and symptoms, he noted, adding, "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."