BARDA to collaborate with Chembio Diagnostics on two COVID-19 rapid antigen tests

With flu season looming, the Biomedical Advanced Research and Development Authority (BARDA) announced plans this week to work with Chembio Diagnostics, Inc. to develop two rapid point-of-care antigen tests capable of detecting and differentiating between COVID-19 and influenza.

Both tests — the DPP SARS-CoV-2 Antigen test system and DPP Respiratory Panel Antigen test system — utilize the New York-based Chembio’s proprietary Dual Path Platform to operate and are capable of turning results out in under 20 minutes. They also use Chembio’s Micro Reader 1 and Micro Reader 2 analyzers, the former of which was cleared by the Food and Drug Administration (FDA) previously for use with tests of HIV, syphilis, and Zika virus.

The DPP SARS-CoV-2 Antigen test allows rapid detection of SARS-CoV-2 antigen through nasal swabs. SARS-CoV-2 is the virus that causes COVID-19. Originally funded by BARDA in July, the test has already been submitted for emergency use authorization (EUA). However, with the additional help from BARDA, Chembio intends to push for 510(k) clearance and develop and request an EUA for an expanded respiratory panel diagnostic.

The second test, the DPP Respiratory Panel, uses a single nasal or nasopharyngeal sample to detect and differentiate between influenza A and B and the SARS-CoV-2 virus. BARDA funding will enable Chembio to push it toward an EUA for use during the 2020-2021 flu season.

As both flu and COVID-19 present respiratory symptoms, healthcare professionals have stressed the importance of rapid testing capable of deciphering between the two. The results could affect treatment and cut the spread of COVID-19.