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.
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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.