FDA Grants EUA to Combination Test for COVID-19, RSV, Influenza

The FDA has granted Emergency Use Authorization (EUA) to Becton, Dickinson and Company’s BD MAX Molecular Diagnostic System combination test for SARS-CoV-2, influenza A + B, and respiratory syncytial virus (RSV).¹

The test involves a single nasal swab or nasopharyngeal swab sample to determine whether a patient has COVID-19, influenza, RSV, or a combination of the 3 viruses. The system is an RT-PCR assay that detects and differentiates the nucleic acid of SARS-CoV-2, flu A, flu B, and RSV in as little as 2 hours for the initial test result.

"While fears of a 'tripledemic' this respiratory season have largely diminished, accurately differentiating influenza and RSV from COVID-19 and providing appropriate treatment remains a challenge for our customers," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD, in the press release. "This diagnostic test provides the ability to identify multiple pathogens using a single sample and can quickly pinpoint the causative virus or viruses and enable clinicians to administer appropriate treatment early in the course of infection."

The new molecular diagnostic combination test may eliminate the need for multiple tests or visits to a physician and may enable providers to initiate the correct course of treatment more quickly, according to BD. Co-testing can also help to improve testing capacity during peak seasons for transmission of respiratory illnesses and to speed the time to diagnosis.

The BD MAX System has already been used at thousands of hospitals and laboratories throughout the world, and can analyze hundreds of samples over a 24-hour period, according to BD. Under the EUA, the test has not yet been cleared or approved by the FDA but is authorized for emergency use by authorized laboratories.

The test is authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2, influenza A, influenza B, and RSV, and is not to be used for detection of any other viruses or pathogens.

The test follows the launch of Roche’s new COVID-19 polymerase chain reaction (PCR) test that specifically targets the XBB.1.5 Omicron sub-variant and runs on the real-time PCR platforms LightCycler 480 II and cobas z480.²

The test, called VirSNiP SARS-CoV-2 Spike F486P, is for research use only and specifically targets the unique mutation F486P found within the XBB.1.5 Omicron sub-variant. Typical clinical samples are throat and nasopharyngeal swabs, sputum, saliva, or gargle solution.

Being able to test for and differentiate the new COVID-19 sub-variant will help experts make predictions about the spread and respond with appropriate treatment strategies. The XBB.1.5 variant, in particular, is prevalent in the United States and is quickly spreading throughout other countries

These new testing options could help providers to more quickly quell outbreaks from the combined impact of all 3 seasonal illnesses.

References

1. BD Receives FDA Emergency Use Authorization for COVID-19, Influenza A/B, RSV Combination Test. Becton, Dickinson and Company. News release. February 7, 2023. https://news.bd.com/2023-02-08-BD-Receives-FDA-Emergency-Use-Authorization-for-COVID-19,-Influenza-A-B,-RSV-Combination-Test

2. Antrim, A. New COVID-19 PCR Test Launched to Detect XBB.1.5 Omicron Sub-Variant. Pharmacy Times. January 31, 2023. https://www.pharmacytimes.com/view/new-covid-19-pcr-test-launched-to-detect-xbb-1-5-omicron-sub-variant