The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Becton, Dickinson and Company’s (BD) novel molecular diagnostic test for both SARS-CoV-2 and influenza A+B.
The BD SARS-CoV-2/Flu assay works on the BD MAX System and distinguishes between SARS-CoV-2 and influenza A+B, offering a positive or negative result for each virus using a single specimen.
It is also CE marked to the IVD Directive (98/79/EC) and can deliver results in two to three hours.
The new EUA has updated data in the test’s instructions for use in detecting variants of the SARS-COV-2 virus such as the UK and South African virus types.
A fully automated, molecular diagnostic platform, the BD MAX System is being used in many laboratories globally.
It lowers the chances of human error and increases the speed to result.
Additionally, the test can process 24 samples simultaneously and up to several hundred samples in 24 hours.
Each unit can perform tests for respiratory infections, enterics, hospital-acquired infections, and sexually transmitted infections.
Becton, Dickinson and Company Integrated Diagnostic Solutions Medical and Scientific Affairs vice-president Dr Charles Cooper said: “The guidelines from the US Centers for Disease Control and Prevention (CDC) recommend testing for both flu and SARS-CoV-2 for all patients who are hospitalised and for patients who will not be hospitalised but for whom a positive result will change clinical management.
“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 are now available in the US and Europe.
Last October, the company received CE mark for the CerTest Biotec VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit.
In November, BD received an order from the Dutch Ministry of Health for 9.2 million of its SARS-CoV-2 antigen tests for use on the BD Veritor Plus System.