The manufacturer Becton, Dickinson and Company (BD) announced that the company received EUA from the FDA for its novel molecular diagnostic combination test for SARS-CoV-2, Influenza A/ B, and RSV. This test will hopefully combat illnesses in the current and upcoming seasons for respiratory viruses.

The manufacturer indicated that the test for use on the BD MAX Molecular Diagnostic System requires a single nasal swab or a single nasopharyngeal swab sample to recognize and distinguish if a patient has COVID-19, the flu, RSV, or some combination of the three viruses.

The BD MAX System is already in usage at thousands of hospitals and laboratories worldwide, and each unit is able to evaluate hundreds of samples over a 24-hour period. The Respiratory Viral Panel for BD MAX System is a reverse transcription polymerase chain reaction assay that detects and differentiates the nucleic acid of SARS-CoV-2, influenza A/B, and RSV in as little as 2 hours for the first result, with the simplified and automated workflow of the BD MAX System.

BD also indicates that this novel combination test assists in eliminating the need for multiple tests or office visits and provides prescribers with key clinical information that will enable them to obtain a diagnosis and initiate the proper therapy in a timely manner. The cotesting approach also facilitates an increase in testing capacity during the busy influenza/RSV season and accelerates the time to obtaining a diagnosis.

Nikos Pavlidis, vice president of molecular diagnostics at BD, stated, “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. 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 development of this novel combination test has been funded in whole or in part with federal funds from the Department of Health and Human Services, Office of the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority.

The BD Respiratory Viral Panel for BD MAX System has not been FDA cleared or approved but has been authorized for emergency use by FDA under EUA for use by authorized laboratories. Moreover, this product has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus, not for any other viruses or pathogens. The EUA of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S. Code section 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.

« Click here to return to COVID-19 update.