The test is part of a new class of faster screening tools called identification proteins called antigens that it detects on the surface of SARS-CoV-2.
The diagnostic maker said on Wednesday that a Covid-19 test by Becton Dickinson and Co that returns results within 15 minutes has been approved for use in countries that accept the European CE mark.
The test is part of a new class of faster screening tools called identification proteins called antigens that it detects on the surface of SARS-CoV-2. Becton Dickinson expects the test, which runs on the company's mobile-sized BD Veritor Plus, will start selling in European markets at the end of October. It is likely to be used by emergency departments, general practitioners, and pediatricians.
"It's a really game-changer introduction here in Europe," said Fernand Goldblatt, Head of Diagnostics Europe at BD. He said that Europe was really at the epicenter of the epidemic in April and May, "Unfortunately I think we are heading back in this direction. So the need will be very acute."
Antigen tests have emerged as a valuable tool because they give results much faster than standard PCR diagnostic assays. However, it is generally less accurate. In the United States, for example, instructions for BD recommend confirming negative results with a molecular test method.
Becton Dickinson said his antigen test is 93.5% sensitive, which is a measure of the number of times it correctly identifies an infection, and 99.3% specifics the rate of correct negative tests. A spokesperson for Troy Kirkpatrick said the data, which differs from the US marker's sensitivity of 84% and specificity of 100%, comes from a new clinical study recently submitted to the FDA.
European invasions
Rapid antigen testing has made progress in Europe, and US company Roche Holding AG said this month that it will launch its 15-minute antigen test for European markets that accept the CE mark. Another test developer, LumiraDx, received the CE marking for antigen testing late last month. It said it plans to manufacture 2 million tests in September and up to 10 million in December.
Goldblatt said the Becton Dickinson VR system is largely used to screen for influenza in Europe so far, but that the new test could help drive adoption of a wider antigen test, including influenza and other respiratory viruses.
He said that the company is currently in talks in several European countries, to a large extent with governments and health authorities, about "where and how our solutions will be appropriate."
The test is already available in the US, Bicton Dickinson said, it is on track to produce about 8 million per month by October across its global markets, and 12 million per month by March 2021.
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