BD nets Dutch government contract for over 9M rapid antigen tests for COVID-19

18 November 2020


Antigen

BD has secured a purchase order from the Netherlands to provide millions of rapid COVID-19 antigen tests to the country, marking its first government contract in Europe since the diagnostic received a CE mark in September.


The company’s hand-held Veritor Plus system—which was granted an emergency coronavirus authorization by the FDA in July—operates similarly to the platform’s rapid flu swab test and is designed to deliver a result in 15 minutes.

The contract with the Dutch Ministry of Health includes an initial delivery of 1.2 million units this month, followed by an additional 8 million by June of next year.

The portable, point-of-care system is currently used by healthcare professionals across Europe to process diagnostic tests for influenza A and B, strep throat and respiratory syncytial virus.

Previously, following the U.S. authorization this past summer, BD said it planned to increase its manufacturing capacity to at least 2 million COVID-19 tests per week going forward. The diagnostic has demonstrated a false-negative rate of 16% while delivering zero false positives in clinical studies, according to the company.

Still, this week the FDA warned healthcare professionals of the possibility of false-positive readings with any rapid antigen test if the diagnostic’s instructions are not completely followed.

The agency said it has received reports of false-positive results in nursing homes and other healthcare settings and is monitoring various companies’ test performance—and it re-upped its recommendations that laboratories perform routine follow-up testing using a molecular assay.

Specifically, the FDA urged lab technicians to ensure test components are stored properly and that test results are read at the correct time to help guarantee accuracy. In addition, cross-contamination risks and processing multiple samples in batches could lead to imprecise readouts.


Published by www.fiercebiotech.com on November 4th, 2020