Dr. Vincent Carrao draws blood from a patient for the coronavirus (COVID-19) test at Palisades Oral Surgery in Fort Lee, New Jersey, the United States, June 15, 2020. Image taken June 15, 2020.
Brendan McDermid | Reuters
A test to detect Covid-19, which can be carried out at the treatment site and provides results in 15 minutes, has been given the green light in Europe, according to the manufacturer Becton Dickinson.
The test should be available in stores in Europe by the end of October, the diagnostics specialist announced on Wednesday when it became known that its antigen test in Europe has been given a "CE mark", which means that it meets the health, safety and and environmental standards for Europe corresponds to products sold within the region.
The new test provides results in 15 minutes on a small, portable instrument, BD said, adding that it is a "critical improvement in turnaround time for Covid-19 diagnostics as it provides real-time results and enables decision-making while being patient still on site. "
"The addition of a truly portable point-of-care test that can provide results while the patient waits is welcomed by healthcare providers and patients alike to help protect against additional waves of Covid-19," said Roland Goette, BD EMEA.
It is by no means alone in developing a rapid antigen test for the virus. Roche announced in early September that its own 15-minute antigen test had received the CE mark, and German diagnostic test maker Qiagen announced earlier this month that it was planning to roll out a 15-minute antigen test.
The U.S. Food and Drug Administration granted emergency approval in July for the company's rapid antigen test, which looks for proteins on or in the Covid-19 virus.
It has been widely reported that antigen tests, while faster than molecular diagnostic tests, which are done in laboratories, are generally less accurate.
According to Becton Dickinson, clinical studies conducted in more than 20 locations across the United States have shown the test to have a sensitivity of 84% (a measure of how well it correctly identifies infections) and 100% specificity (how well correctly identifying negative tests). However, the FDA recommends confirming negative test results through a molecular method to confirm the result.
BD said it is leveraging its global manufacturing network and scalability to produce 8 million Covid-19 antigen tests per month by October and expects to produce 12 million tests per month by March.
In mid-September, it was reported that BD was reviewing reports from nursing homes that its rapid Covid-19 test devices were producing false positive results in some cases.