On May 7, 2019, Chembio Diagnostics announced the approval of its DPP Dengue System by Agência Nacional de Vigilância Sanitária (ANVISA), Brazil’s health regulatory agency, in collaboration with Bio-Manguinhos, a Brazilian government agency and supplier of diagnostic products to Brazil’s Ministry of Health.

Chembio’s DPP Dengue test allows simultaneous and discrete detection of antibodies against all four dengue serotypes for both active infection by dengue virus (IgM) and prior exposure to the dengue virus (IgG), 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 dengue 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, yielding sensitivity of 96.6% and 100% and specificity of 99.0% and 99.0%, for IgM and IgG antibody detection respectively.

Dengue is a mosquito-borne virus that is transmitted by female mosquitoes, mainly the species Aedes aegypti and, to a lesser extent, Aedes albopictus, which also transmit chikungunya, yellow fever and Zika viruses. Dengue is caused by a virus of the Flaviviridae family and there are 4 distinct, but closely related, serotypes of the virus that cause dengue (DEN-1, DEN-2, DEN-3 and DEN-4). According to the World Health Organization, there are nearly 400 million annual dengue infections and 3.9 billion people, in 128 countries, are at risk of infection with dengue viruses. According to the Pan American Health Organization (PAHO), Brazil has reported nearly 600,000 cases of dengue during 2019, including nearly 400 cases of severe dengue, and 169 dengue-related deaths.