Single Molecular Diagnostic Combination Test Identifies and Differentiates Multiple Respiratory Infectious Diseases

Last year, the risk of a 'tripledemic' was a major concern as COVID-19, influenza, and Respiratory Syncytial Virus (RSV) were all in circulation at the same time, presenting with nearly identical symptoms in patients. In response to this continued threat for the upcoming respiratory season, a new combined testing panel now allows healthcare professionals to rapidly and accurately diagnose, differentiate, and treat COVID-19, influenza, and RSV, aiding in controlling the spread of these respiratory infections.

Becton, Dickinson and Company’s (BD Franklin Lakes, NJ, USA) BD Respiratory Viral Panel (RVP) for BD MAX System is a single molecular diagnostic test that can identify and differentiate between SARS-CoV-2, influenza A, influenza B, and RSV in roughly two hours. The test requires just a single nasal or nasopharyngeal swab sample to ascertain if a patient has COVID-19, the flu, or RSV. The BD RVP test mitigates the need for multiple separate tests or doctor appointments, enabling clinicians to quickly implement appropriate treatment plans. This co-testing method also helps to increase testing capacity during the hectic flu season and accelerate the time for diagnosis.

The BD MAX System, a molecular diagnostic platform already being utilized in thousands of hospitals and medium-capacity labs globally, can analyze hundreds of samples within a 24-hour period. The BD MAX RVP test is an RT-PCR assay capable of detecting and differentiating the RNA of SARS-CoV-2, flu A, flu B, and RSV in about two hours, with the BD MAX System's simple and automated "walkaway workflow" that necessitates minimal human interaction. The respiratory viral panel further adds to the wide range of assays available on the BD MAX System, including those for respiratory infections, sexually transmitted infections, gastrointestinal infections, women's health, and healthcare-associated infections. The BD MAX open system also allows customers to quickly address emerging needs by using research use only (RUO) assays and user-defined protocols (UDP).

The BD Respiratory Viral Panel for BD MAX System received CE marking under the IVD directive 98/79/EC in May 2022 and has been available in the United States since February via an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The BD Respiratory Viral Panel (RVP) for BD MAX System has now been granted FDA 510(k) clearance. Consequently, BD will discontinue the BD RVP EUA version and replace it with the 510(k) version, ensuring no interruption in the test's availability.

"Last year, we experienced a threat of a 'tripledemic' with COVID, flu and RSV circulating simultaneously, and that threat remains for the coming respiratory season," said Nikos Pavlidis, vice president and general manager for Diagnostics at BD. "As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients, and help manage the spread of the infections. The advanced robotic architecture of the BD MAX System automates manual, time-intensive processes, which has never been more important than in today's environment of staffing shortages and laboratory scientist burnout."

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