BD has secured U.S. and European authorizations for a new COVID-19 test that screens for the coronavirus as well as influenza A and B—and the company said it’s shown to work against the emerging variants first identified in the U.K. and South Africa.
The molecular laboratory test is designed to turn around results in two to three hours, and process hundreds of samples per day on the company’s BD MAX platform.
“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,” said Charles Cooper, BD’s diagnostics VP for medical and scientific affairs.
“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,” Cooper added.
To evaluate the test’s accuracy against new coronavirus mutations—including the fast-spreading B.1.1.7 and B.1.351 variants, first spotted in the U.K. and South Africa, respectively—BD performed computer analyses showing that 99.9% of the genetic sequences of these viruses would still match up to the molecular targets used in its tests, including its new combined diagnostic, as well as its standalone screeners for COVID-19.
The FDA recently said it believes the overall threat to diagnostic accuracy remains low—though viral mutations may affect certain products more than others—and that it has been working with developers to evaluate and re-evaluate the impact of different mutations on their tests.
The agency also said it is considering “expanding the role of in silico monitoring,” and the use of computer models to simulate how changes in the virus’ genome may affect a test’s performance.
In early January, the FDA warned that new mutations could trigger false negatives if a test solely relies on a specific, altered portion of the coronavirus’ genetic code.