Chembio Diagnostics launched a rapid point-of-care COVID-19/Flu A&B test for use in decentralized and traditional testing settings, according to a news release.
The company said the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the product.
The rapid immunoassay test is approved for use in laboratories with a CLIA waiver license, produces results in 15 minutes and requires no instrumentation. The test simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections from a single swab.
“As COVID-19 converges with the flu, it is critical for physicians to be able to quickly differentiate between these viruses at the point-of-care, which present with nearly identical symptoms, in order to take appropriate clinical actions and maximize efficient use of healthcare resources,” said Charles Caso, Vice President of Sales and Marketing for Chembio. “Based on recent research, we expect that the spread of COVID-19 will eventually transition from a pandemic to an endemic state, with the virus surviving among the population at a lower incidence. In this scenario, coupled with the return to normalcy in society, we see COVID-19 testing remaining a crucial and integral component of broader respiratory testing.
