FDA Grants 501(k) Clearance to Triple Assay for Influenza, RSV, and COVID-19

The US Food and Drug Administration (FDA) on Tuesday granted 510(k) clearance to Becton, Dickinson and Company’s (BD) Respiratory Viral Panel (RVP) test, a single molecular diagnostic combination test that quickly identifies—and distinguishes—SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), according to a company statement.¹

Based on a single nasal or nasopharyngeal swab, the RT-PCR assay-based test returns results in approximately 2 hours, according to BD. Eliminating the need for multiple individual assays or clinic visits, the combination diagnostic test has the potential to reduce the time between testing and treatment initiation and, importantly, to increase testing capacity during the typically hectic respiratory virus season.

"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.”¹

The BD RVP diagnostic test works with the BD MAX molecular diagnostic platform already in use worldwide, according to the statement. With health care staff shortages still widespread and laboratory scientists putting in extra hours, the automation of manual and time-intensive procedures has never been more important, adds Pavlidis. The BD MAX system, he notes, has the capacity to analyze hundreds of samples simultaneously in a 24-hour period.

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.

Current assays in the BD MAX System test for other respiratory infections, sexually transmitted infections, gastrointestinal infections, women's health, and health care-associated infections.

The FDA approved the BD RVP assay in February under an emergency use authorization (EUA). With 510(k) clearance, the BD RVP diagnostic test will replace the BD RVP EUA with no gaps in availability of the test, said BD.¹

The novel assay will be available prior to the start of the 2023-2024 respiratory virus season, which, like last season, has the potential to tax the health care system with COVID-19, influenza, and RSV all in circulation at approximately the same time.

Vaccination recommendations 2023-2024

Influenza. To protect against severe illness or hospitalization related to influenza, the Advisory Committee on Immunization Practices recommends that all US residents aged ≥6 months be vaccinated with the ideal administration period between September and October. For adults aged ≥65 years, either Fluzone High-Dose Quadrivalent inactivated, FluBlok Quadrivalent recombinant, or Fluad Quadrivalent adjuvanted inactivated flu vaccines are preferentially recommended.²

Vaccine recommendations 2023-2024

COVID-19. While it remains to be seen how the CDC will recommend use this season of the monovalent COVID-19 vaccines against the XBB1.5 variant (ie, specific populations, timing), currently the guidelines recommend a single bivalent (booster) dose for most persons aged ≥6 years; bivalent vaccines for children 6 months to 5 years, and optional additional bivalent booster doses for moderately or severely immunocompromised persons aged ≥6 months and adults aged ≥65 years.²

RSV. For the 2 just-approved vaccines against RSV for adults, the recommendation is that clinicians and their patients aged ≥60 years use a shared decision-making process to determine if the vaccine is right for them, taking into consideration the person’s risk of severe RSV infection, underlying health conditions, other health characteristics, and their values and preferences.⁴

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. Centers for Disease Control and Prevention. Flu news & spotlights. June 29, 2023. Accessed August 1, 2023. https://www.cdc.gov/flu/spotlights/2022-2023/flu-vaccination-recommendations-adopted.htm

3 Moulia DL, Wallace M, Roper LE, et al. Interim Recommendations for Use of Bivalent mRNA COVID-19 Vaccines for Persons Aged ≥6 Months — United States, April 2023. MMWR Morb Mortal Weekly Rep. 2023;72(24):657–662.

4. Statement from HHS Secretary Xavier Becerra on CDC's Historic Recommendation Allowing Older and Immunocompromised Adults to Receive the RSV Vaccine. US Department of Health and Human Services. News release. June 29, 2023. Accessed August 2, 2023. https://www.hhs.gov/about/news/2023/06/29/statement-hhs-secretary-xavier-becerra-cdcs-historic-recommendation-allowing-older-immunocompromised-adults-receive-rsv-vaccine.html