‘Game Changing’ 15 minute Covid-19 test cleared in Europe.
Becton Dickinson’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 has just announced.
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.
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.
Becton Dickinson said its antigen assay is 93.5% sensitive, a measure of how often it correctly identifies infections, and 99.3% specific, the rate of correct negative tests. BD says it is on track to produce about 8 million each month by October.
Rapid antigen testing is also now available in Europe from two other companies. Roche Holding AG said it would launch its own 15 minute antigen test to European markets accepting the CE mark, this month. Another test developer, LumiraDx, received CE marking for its antigen test late last month. It said it planned to manufacture as many as 10 million in December.