- A test to detect Covid-19 that can be done at the point of care and gives results in 15 minutes has been given the greenlight in Europe, maker Becton Dickinson said.
- The test should be commercially available in Europe by the end of October.
- The Food and Drug Administration granted emergency use authorization in July.
A test to detect Covid-19 that can be done at the point of care and gives results in 15 minutes has been given the greenlight in Europe, according to its maker, Becton Dickinson.
The test should be commercially available in Europe by the end of October, the diagnostics specialist said Wednesday, as it announced its antigen test had been granted a "CE mark" in Europe, meaning it conforms with health, safety, and environmental protection standards for products sold within the region.
The new test delivers results in 15 minutes on a small, portable instrument, BD said, adding that this is a "critical improvement in turnaround time for Covid-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite."
"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," BD EMEA Roland Goette said.
It is by no means alone in developing a rapid antigen test for the virus. Roche announced earlier in September that its own 15-minute antigen test had received the CE mark and German diagnostic test maker Qiagen also announced earlier this month that it planned to launch a 15-minute antigen test.
The U.S. Food and Drug Administration granted emergency use authorization in July to the company's rapid antigen test, which works by looking for proteins that can be found on or inside the Covid-19 virus.
It has been widely reported that while antigen tests can be carried out faster than molecular diagnostic tests conducted in laboratories, they are generally less accurate.
Becton Dickinson says that clinical studies performed at more than 20 sites across the U.S. demonstrated that the test is capable of achieving 84% sensitivity (a measure of how well it correctly identifies infections) and 100% specificity (how well it correctly identifies negative tests) but the FDA recommends that negative test results be confirmed by a molecular method to confirm the result.
BD said it is leveraging its global manufacturing network and scale 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 looking into reports from nursing homes that its rapid Covid-19 testing equipment was producing false positive results in some cases.