Story at a glance
- Becton Dickinson’s coronavirus test that can deliver results in 15 minutes has been approved in Europe.
- The quick turnaround time for test results means patients won’t have to wait for their test to be sent to a lab.
- Becton Dickinson says it expects the rapid tests to become commercially available at the end of October.
A rapid coronavirus test that can deliver results in just 15 minutes has been cleared for use in Europe and is expected to hit the market next month.
New Jersey-based diagnostics maker Becton Dickinson announced on Wednesday that its COVID-19 testing kit has met the requirements to be sold in countries that accept Europe’s CE marking — similar to a Food Drug and Administration (FDA) approval in the United States. The marking shows a product meets European Union safety standards.
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The test is performed using the manufacturer’s cellphone-sized BD Veritor Plus System, which is already used to test for the flu and strep throat. The quick turnaround time for test results means patients won’t have to wait for their test to be sent to a lab. The tests will likely be used by emergency departments, general practitioners and pediatricians.
“The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of COVID-19,” Roland Goette, president of Becton Dickinson’s Europe, Middle East and African Region, said in a statement.
Becton Dickinson says it expects the rapid tests to become commercially available at the end of October. The antigen tests have been available in the U.S. since July under an emergency use authorization from the FDA.
While the antigen tests are valuable for their ability to produce results much more quickly than polymerase chain reaction (PCR) tests, they are generally less accurate.
A spokesperson for Becton Dickinson told Bloomberg that a clinical study shows the rapid test correctly identifies infections 93.5 percent of the time and negative results with 99.3 percent accuracy.
The approval comes as a second wave of coronavirus has hit some European countries, forcing many governments to move forward on reintroducing restrictions.
Health experts have maintained throughout the pandemic that the only way to contain the virus without a vaccine is frequent testing, tracing and isolation.
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Published on Sep 30,2020