USA — BD has received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B, and Respiratory Syncytial Virus (RSV).
Designed to help combat illness in the current and future respiratory virus seasons, the test is claimed to enable clinicians to rapidly implement the right treatment plan.
Furthermore, the co-testing process will help enhance testing capacity as well as speed time to diagnosis during the busy flu/RSV season, stated BD.
Even now in the U.S., weekly new Covid cases hover around 300,000, and weekly death rates are around 3,000.
According to new data from the Centers for Disease Control and Prevention, early waves of respiratory syncytial virus and influenza peaked before the new year.
The expected winter increase in coronavirus is nowhere near overwhelming hospitals, as it did in 2021 when covid wards were overrun with unvaccinated people struggling to breathe, or last winter when the highly transmissible omicron variant sparked a massive wave of illness.
According to WHO, nearly 10.5 million new cases and over 90 000 Covid-19 related deaths were reported in the last 28 days (9 January to 5 February 2023) globally, a decrease of 89% and 8%, respectively, compared to the previous 28 days.
As of 5 February 2023, over 754 million confirmed cases and over 6.8 million Covid-related deaths have been reported globally.
How BD Max System works
BD Respiratory Viral Panel for BD MAX System is an RT- PCR assay is designed for use on the BD MAX Molecular Diagnostic System.
The test requires a single nasal swab or a single nasopharyngeal swab sample, to detect and differentiate between Covid-19, the flu, RSV, or their combination.
Based on simplified and automated workflow of the BD MAX System, the BD Respiratory Viral Panel delivers results within two hours.
BD MAX System is intended for in vitro diagnostic (IVD) use in performing FDA-cleared or approved nucleic acid testing in clinical laboratories.
It is capable of automated extraction and purification of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR.
BD molecular diagnostics vice president Nikos Pavlidis said: “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.”
BD said its BD MAX System already is used in thousands of hospitals and laboratories around the globe and each unit can analyze hundreds of samples in 24 hours.
It enables customers to quickly address emerging needs by leveraging research-use-only (RUO) assays and user-defined protocols (UDP).
The BD Respiratory Viral Panel for BD MAX System is an important addition to the BD MAX System’s extensive assay library.
There are tests for respiratory infections, sexually transmitted infections, gastrointestinal infections, and infections associated with healthcare.
The test is said to reduce the need for multiple tests or doctor visits and to assist clinicians in quickly implementing the best treatment plan.
Furthermore, according to BD, its co-testing approach supports the expansion of testing capacity during the busy flu/RSV season and reduces the time to diagnosis.
BD noted it developed the test with funding from the U.S. Department of Health and Human Services, with its Office of the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA).
Early this month, BD introduced Single-Cell Multiomics analysis platform, the BD Rhapsody HT Xpress System that will enable scientists to run high-throughput studies without sacrificing sample integrity.
BD also introduced the new third-generation BD Kiestra Total Lab Automation System for microbiology laboratories last month.
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