FDA Gives 510(k) Clearance to Respiratory Viral Panel Test for Rapid RSV, COVID-19 Detection

The FDA granted 510(k) clearance to Becton, Dickinson and Company’s (BD) Respiratory Viral Panel (RVP) test, a novel polymerase chain reaction (PCR) assay that can quickly determine whether a patient has COVID-19, influenza A, influenza B, or respiratory syncytial virus (RSV), according to a recent BD press release.¹

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The BD RVP is a single molecular diagnostic combination test that uses a single nasal swab sample to detect or determine the presence of COVID-19, influenza A, influenza B, or RSV. BD anticipates that the test will mitigate the need for separate tests or physician visits and contribute to faster treatment.

The BD RVP diagnostic test serves as an additional assay to The BD MAX System. The BD MAX System is a molecular diagnostic platform that can analyze hundreds of samples at once during a 24-hour period.

“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," Pavlidis said in the press release.

Current assays in the BD MAX System test for respiratory infections, sexually transmitted infections (STIs), gastrointestinal infections, women's health, and health care-associated infection. The system also includes research use only (RUO) assays and user-defined protocols (UDP).

The FDA already approved the BD RVP assay in February under emergency use authorization (EUA). With 510(k) clearance, the BD RVP diagnostic test will replace the BD RVP EUA version and be available for everyone.

The novel assay will be available prior to the start of flu season, which experts believe will be a “tripledemic” of COVID-19, influenza, and RSV all in circulation.

“That threat remains for the coming respiratory season," Pavlidis said in the press release.

To treat flu during the 2023-2024 season, the Advisory Committee on Immunization Practices’ (ACIP) recommends anyone in the United States aged 6 months and older receive an annual influenza vaccination—the Centers for Disease Control and Prevention (CDC) support this recommendation. It is also recommended that people get vaccinated in September and October for optimal protection against the flu.²

The CDC updated their COVID-19 vaccine recommendations as well, requesting that everyone aged 6 years and older get a bivalent (booster) mRNA vaccine. The update recommends multiple doses for young children depending on age and vaccine, and it allows adults ages 65 years and older or immunocompromised individuals to receive a booster dose.³

"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,” said Nikos Pavlidis, vice president and general manager for Diagnostics at BD, in the press release.¹

References

1. BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test. BD. News Release. August 1, 2023. Accessed on August 1, 2023. https://news.bd.com/2023-08-01-BD-Receives-510-k-Clearance-for-COVID-19,-Influenza-A-B,-RSV-Molecular-Combination-Test
2. 2023-2024 CDC Flu Vaccination Recommendations Adopted | CDC. CDC. News Release. Accessed August 1, 2023. https://www.cdc.gov/flu/spotlights/2022-2023/flu-vaccination-recommendations-adopted.htm#:~:text=The%202023%2D2024%20season%20U.S.,cell%2Dbased%20or%20recombinant%20vaccines.
3. CDC simplifies COVID-19 vaccine recommendations, allows older adults and immunocompromised adults to get second dose of the updated vaccine. CDC. April 19, 2023. Accessed on August 1, 2023. https://www.cdc.gov/media/releases/2023/s0419-covid-vaccines.html