Chembio’s test for Zika, dengue and chikungunya approved by Brazil health regulator
Chembio Diagnostics’ (NASDAQ:CEMI) Zika/dengue/chikungunya multiplex test has been approved by Brazil’s health regulatory agency, ANVISA.
The test uses Chembio’s DPP technology platform to detect both active infection with, and prior exposure to the Zika, dengue, and chikungunya viruses. The test requires a small drop of fingertip blood and provides results in approximately 15 minutes.
“Co-circulation [of Zika, dengue, and chikungunya] 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,” John Sperzel, Chembio’s CEO, said in a statement.
Brazil’s National Institute of Health Quality Control determined the test’s sensitivity to be between 95.2% and 100%, and its specificity to be between 96.6% and 100%.