Chembio gets approval in Brazil for dengue POC test

2019 05 07 23 35 0376 Brazil Flag 400

Chembio Diagnostics has received approval from Brazilian regulatory authorities for a blood test to detect the dengue virus at the point of care (POC).

Brazil's Agência Nacional de Vigilância Sanitária (ANVISA) approved Chembio's DPP Dengue system, giving the company clearance to market the test in the country.

DPP Dengue enables the detection of antibodies against all four serotypes of the dengue virus, detecting both active infection (immunoglobulin M, IgM) and prior exposure to the dengue virus (immunoglobulin G, IgG), which is important for treatment and surveillance.

DPP Dengue is performed using a 10-µL drop of blood from the fingertip and delivers quantitative results in about 15 minutes when used with the company's handheld DPP Micro Reader. An evaluation study of the test performed in Brazil found that it had sensitivity of 96.6% and 100% and specificity of 99% and 99% for IgM and IgG antibody detection, respectively.