BD today said it received FDA emergency use authorization and CE mar approval for its rapid molecular diagnostic test for both SARS-CoV-2 and Influenza A+B test.
The test can return results in two to three hours and the FDA EUA includes updated information in the test’s instructions for use that addresses variants of the SARS-CoV-2 virus, including the variants from the U.K. and South Africa. A computer analysis showed that 99.9% of the genetic sequences of the new variants are an identical match to at least one of the two molecular targets for the test.
The ability to detect the new variants applies to the standalone SARS-CoV-2 test for the BD Max System.
BD’s SARS-CoV-2/Flu assay runs on the BD Max System and distinguishes between SARS-CoV-2 and Influenza A+B from a single specimen.
“The guidelines from the U.S. Centers for Disease Control and Prevention recommend testing for both Flu and SARS-CoV-2 for all patients who are hospitalized and for patients who will not be hospitalized but for whom a positive result will change clinical management,” Charles Cooper, BD’s VP of medical and scientific affairs for integrated diagnostic solutions, said in a news release. “Since COVID-19 and Flu often present with similar symptoms, such as fever and dry cough, having a single specimen for accurate diagnosis speeds time to results and helps clinicians determine the right care more quickly to help prevent community transmission.”
The BD SARS-CoV-2/Flu for the BD Max System kits are available for order in the U.S. and Europe.
“Our diagnostic solutions for COVID-19 and Flu will help inform timely diagnosis and, ultimately, may contribute to faster and clinically appropriate patient management and treatment,” BD life sciences president Dave Hickey said. “In addition, the new information provided on the test’s ability to detect the U.K. and South African variants provides helpful guidance to health care practitioners as we look to identify and contain these new strains.”
The tests have not been FDA cleared or approved.