The test is expected to be commercially available in Europe by the end of October, a diagnostic expert said on Wednesday, as he announced that the antigen test had received a "CE mark" in Europe, which means that it complies with the standards. health, security and protection environment for products sold within the area.
In particular, it provides results in 15 minutes on a small, portable instrument, said BD on Wednesday, adding that it was ""Critical improvement of time for Covid-19 diagnostics, because it provides real-time results and allows decisions to be made while the patient is still there."
«Adding a truly portable test that can deliver results while the patient waits will be welcomed by healthcare providers and patients who want to help protect against extra waves of the virus.Said Roland Goette, president of BD EMEA.
In July, the US Food and Drug Administration (FDAissued an emergency license for 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 performed faster than molecular diagnostic tests performed in laboratories, they are generally less accurate.
Becton Dickinson says clinical trials conducted at more than 20 sites in USA showed that the test is capable of achieving 84% sensitivity (a measure of how well it detects infections) and 100% specificity (how well it correctly detects negative tests), but the US FDA recommends that the test results be confirmed with a molecular method to confirm the result.
BD said it was utilizing its global production network and scale to produce 8 million Covid-19 antigen tests per month by October. It also expects to conduct 12 million tests per month by March 2021.
Of course, she is not alone in developing a rapid antigen test for the virus, with Roche announcing earlier in September that its own 15-minute antigen test had received the CE mark.
In mid-September, it was reported that BD was reviewing reports from nursing homes, and the rapid Covid-19 test equipment produced false positive results in some cases.