Chembio Diagnostics received approval of Zika, Dengue and Chikungunya point-of-care multiplex test by Brazil’s Health Regulatory Agency

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On Apr. 9, 2019, Chembio Diagnostics announced the approval of its DPP Zika/Dengue/Chikungunya System by Agencia Nacional de Vigilancia Sanitaria (ANVISA), Brazilis 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 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.

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Source: 360Dx
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