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16th February 2021 Product update: rapidvirology staff writer
New Test for SARS-CoV-2 & Influenza Now Authorized in US and Europe
BD (Becton, Dickinson and Company) has announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new molecular diagnostic test for both SARS-CoV-2 and Influenza A+B that can return results in two to three hours. The new test also has been CE marked to the IVD Directive (98/79/EC).
The new EUA includes updated information in the test's instructions for use that addresses variants of the SARS-COV-2 virus, including variants from the U.K. and South Africa.
A computer analysis showed that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for the test. This ability to detect these new variants also applies to the standalone SARS-CoV-2 test for the BD MAX™ System.
The BD® SARS-CoV-2/Flu assay is run on the BD MAX™ System and distinguishes between SARS-CoV-2 and Influenza A+B, providing a positive or negative result for each virus using a single specimen.
The BD MAX™ System, a molecular diagnostic platform, is already in use at thousands of laboratories worldwide, and each unit is capable of analyzing hundreds of samples over 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," said Cooper.
The BD® SARS-CoV-2/Flu for BD MAX™ System kits are now available for order in the United States and Europe. The test is the latest addition to the company's comprehensive COVID-19 diagnostics response.
In October 2020, BD announced the CE-mark for the CerTest Biotec VIASURE SARS-CoV-2 (N1 + N2) Real-Time PCR Detection Kit, which allows BD MAX™ System users to combine as a single test the VIASURE Flu A, Flu B & Respiratory Syncytial Virus (RSV) Real-Time PCR Detection Kit and report concurrently.
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Date Published: 16th February 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
Point-of-Care Rapid Flu and SARS-CoV-2/