New Clinical Data Shows BD Antigen Test May Be More Selective In Detecting Infectious COVID-19 Patients Than Molecular Tests
Peer-Reviewed Study Suggests BD Antigen Test Likely to Be More Selective at Detecting Patients Who Are Shedding Infectious SARS-CoV-2 Virus
FRANKLIN LAKES, N.J., Jan. 25, 2021 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the publication of a peer-reviewed study that shows BD's antigen test may be more selective than PCR (polymerase chain reaction) molecular tests at detecting people who are contagious and able to spread COVID-19 disease.
The study compared antigen and PCR test results to positive results using a viral cell culture test. Viral growth in the cell culture test indicates the presence of live virus in the patient sample, which may indicate the presence of infectious virus at the time the sample was taken. If no growth is present in the viral cell culture test, it is likely that there wasn't enough viable virus for the patient to be contagious at the time the sample was taken.
Out of 38 positive PCR result specimens tested, only 28 were positive using the cell culture technique. The antigen tests, conducted using the BD Veritor™ Plus System, were positive in 27 of the 28 cell culture positive tests. This data suggests that 10 of the 38 PCR positive results were potentially identifying non-infectious individuals, meaning PCR detected viral RNA fragments or small amounts of intact SARS-CoV-2 virus and that the patient wasn't actually contagious at the time the sample was taken. However, the BD antigen test agreed with all but one cell culture positive test. Diagnosing and isolating contagious people has been the primary goal for testing during the pandemic, followed by contact tracing and testing.
"Point-of-care antigen tests, as demonstrated in this study with the BD Veritor™ Plus System, have the potential to significantly change the public health interventions needed to minimize the spread of COVID-19," said Dr. Charles Cooper, study co-author and vice president of Medical Affairs for BD. "By providing a more relevant test to identify individuals that are likely to be shedding infectious virus and therefore transmit SARS-CoV-2, we will be in a better position to contain its spread. Plus, the low cost and scalability of antigen-based testing makes it an important tool to contain and suppress COVID-19 community transmission."
The new clinical data was published Jan. 22, 2021 in Clinical Infectious Diseases, an official journal of the Infectious Diseases Society of America.
About the BD Veritor™ System for Rapid Detection of SARS-CoV-2 Assay
This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and, 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. For more information on the BD Veritor™ Plus System, please visit BDVeritor.com.
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.
Kristen M. Stewart, CFA
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SOURCE BD (Becton, Dickinson and Company)
Released January 25, 2021