BD develops innovative technologies, services and solutions to help the healthcare community improve safety and increase efficiency. Joseph Mann, MSN, FNP-C, Global Medical Science Liaison at BD, is a board-certified family nurse practitioner, who shares with Healthcare Purchasing News (HPN) how the company is improving viral testing today and for years to come.
HPN: As reports emerge of COVID, flu and RSV declining in hospitals and the general public succumbs to COVID-19/pandemic fatigue and numbness, how might this affect demand for and interest in a virus detection test that distinguishes between COVID-19, influenza A, influenza B and RSV?
MANN: I think we’re at a dull point now where we’re seeing lower case rates and a little bit of pandemic fatigue, which has fully led to a decrease in demand for testing to a certain extent. But I also think it’s important that everyone consider and recognize that the usual patterns, especially flu and RSV circulation that we’ve been accustomed to seeing, have been massively disrupted by the pandemic. When everyone started imposing restrictions and staying at home – for example, mask-wearing and social distancing and capacity limits – those types of things really interrupted the normal pattern of flu and RSV transmission. As an example, we saw a sharp rise in both flu and RSV cases in early and late fall of last year. Usually, we see this happening later on during the winter months of December and January. This same pattern of unpredictability occurred in other parts of the world as well.
I’ll remind everyone that even last year in late May we saw a significant rise in flu cases here in the U.S. When you couple that with the variances in the COVID-19 virus that are continuing to evolve and pose challenges to vaccine efficacy, the overall point that I’m trying to stress here is that things can change at any moment. And while cases seem to be on the downtrend now, and we’re hopeful that pattern will continue, we need to stay vigilant and be prepared.
Symptoms for common respiratory viruses can resemble those for COVID-19 so how does the BD Veritor™ Plus System delineate positive and negative results for the clinician and/or end user administering the test?
The BD Veritor™ Plus System is our rapid antigen testing platform, which is for use with healthcare providers only in point-of-care settings like urgent care centers, doctors’ offices and pharmacies, etc. Clinicians use the BD Veritor™ Plus System to conduct rapid testing at the point of care. It offers a broad menu of assays, including tests for COVID, flu-A, flu-B, RSV and even group A strep.
BD was granted Emergency Use Authorization (EUA) for a rapid antigen test that can detect SARS-CoV-2, influenza A and influenza B in a single test one nasal sample in 15 minutes*. These viruses – flu and COVID – present very similarly with a lot of overlapping symptoms. This makes it really challenging for healthcare providers to accurately diagnose symptoms and presentations alone, so these combination tests can help healthcare providers distinguish and delineate between the symptoms and arrive at a more accurate diagnosis.
BD recently obtained Emergency Use Authorization from the FDA for a new molecular diagnostic combination test for COVID-19, influenza A + B and RSV. What more can you share about this development?
We were very excited to receive that news from FDA. The BD MAX™ Respiratory Viral Panel received emergency use authorization from the FDA earlier this week**. It’s a highly sensitive multiplex assay that can be used by laboratories on the BD MAX™ System to conduct respiratory testing for COVID-19, flu-A, flu-B and also RSV. Given the relevance of these viruses and what we saw this past fall and during the early winter months in the U.S., we’re hopeful this combined PCR assay can allow labs to conduct more efficient testing.
Like our COVID-19 and flu combo assays through BD Veritor™ Plus*, we believe this combined approach can help healthcare providers in distinguishing and diagnosing a lot of these viruses that present very similarly but have very different treatments. These combined testing approaches lead to more accurate diagnoses and more guided antiviral treatments.
*BD Veritor™ At-Home COVID-19 Test (256094)
BD Veritor™ System for Rapid Detection of SARS-CoV-2 (256082)
BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B (256088)
• These products have not been FDA cleared or approved; the BD Veritor™ At-Home COVID-19 Test has been authorized by FDA under EUA; the BD Veritor™ System for Rapid Detection of SARS-CoV-2 and the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B assays have been authorized by FDA under EUA for use by authorized laboratories
• The BD Veritor™ At-Home COVID-19 Test and the BD Veritor™ System for Rapid Detection of SARS-CoV-2 have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; the BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens; and,
• The emergency use of these products 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.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
**BD Respiratory Viral Panel for BD MAX™ System
• This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under EUA for use by authorized laboratories.
• 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 emergency use 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.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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