FDA approves test that can detect flu as well as COVID-19, including U.K., South African variants

The U.S. Food and Drug Administration this week approved a new diagnostic test that can detect both the coronavirus and influenza, according to a global medical technology company. 

Becton, Dickinson and Company announced Friday that the approved BD Max molecular test can return results within two to three hours and also detect the coronavirus variants from the U.K. and South Africa with a 99% accuracy. 

The test distinguishes between SARS-CoV-2, the virus that causes COVID-19 disease, and influenza A and B strains, offering a test result for each virus using a single specimen, the company says. Thousands of labs worldwide are already using the testing platform, and each unit reportedly can analyze hundreds of samples within a 24-hour period. 

“The guidelines from the U.S. Centers for Disease Control and Prevention (CDC) 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 Dr. Charles K. Cooper, vice president of Medical and Scientific Affairs for Integrated Diagnostic Solutions at BD. “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 BD MAX System kits now can be ordered in the United States and Europe. 

As of Saturday, COVID-19 has infected more than 27.5 million and claimed the lives of more than 481,000 in the U.S. The CDC estimates that the flu causes between 9 million and 45 million illnesses and between 12,000 and 61,000 deaths in the country each year. 

The U.K. coronavirus variant has been detected in 981 people in 37 states while 13 people in five states have tested positive for the South African strain as of Thursday, the latest data shows. 

Some common symptoms of COVID-19 and flu include fever, cough, shortness of breath, fatigue, sore throat, runny or stuffy nose, muscle pain, headache, vomiting and diarrhea.