Becton Dickinson and Co.’s Covid-19 test that returns results in 15 minutes has been cleared for use in countries that accept Europe’s CE marking, the diagnostics maker said Wednesday.
The test is part of a new class of quicker screening tools named for the identifying proteins called antigens they detect on the surface of SARS-CoV-2. Becton Dickinson expects to begin selling the test, which runs on the company’s cellphone-sized BD Veritor Plus System, in European markets at the end of October. It will likely be used by emergency departments, general practitioners and pediatricians.
“It is really a game-changing introduction here in Europe,” said Fernand Goldblat, BD’s head of diagnostics for Europe. Europe was really at the epicenter of the pandemic in April and May, “and unfortunately I think we’re headed back in that direction. So the need will be extremely high,” he said.
Antigen tests have emerged as a valuable tool because they produce results much more quickly than gold-standard PCR diagnostic assays. However, they are generally less accurate. In the U.S., for instance, instructions for BD’s system recommend that negative results be confirmed by a molecular testing method.