BD
- Becton Dickinson’s COVID-19 test, which gives results in 15 minutes, has been approved in countries that accept a European Union quality mark, the US company said.
- The rapid antigen test, which is already used in the US, is expected to be on the European market by the end of October.
- It will likely be used by emergency departments, pediatricians and general practitioners, the company said.
- The portable BD Veritor Plus System is part of a new class of coronavirus tests designed to produce results faster than other methods.
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A Becton Dickinson lab-free COVID-19 test that returns results in 15 minutes has been cleared for use in Europe.
The US medical device maker said on Wednesday that its testing kit for coronavirus, which has been available in the US since July, met the requirements to be sold in Europe.
It will be available in countries that recognize the CE mark, which shows that a manufacturer has ensured a product meets European Union safety requirements.
Becton Dickinson said it expects its test to be commercially available in European markets by the end of October. It will most likely be used by emergency departments, pediatricians, and general practitioners, it said.
The portable BD Veritor Plus System can quickly identify antigens on the surface of the coronavirus without requiring a lab. Antigen tests are designed to produce results rapidly, but are generally less reliable than the gold-standard PCR assay.
Troy Kirkpatrick, a spokesperson for Becton Dickinson, said that a new clinical study shows the test correctly identifies infections 93.5% of the time, whilst the rate of correct negative results stands at 99.3%, per Bloomberg.
In the US, the entire system costs between $250 and $300, and tests costs $20 each. Becton Dickinson's head of diagnostics for Europe, Fernand Goldblat, said the company was talking governments and health authorities in Europe about "where and how our solutions would fit."
"It is really a game-changing introduction here in Europe," he said. April and May were the worst months for COVID-19 in Europe and "unfortunately I think we're headed back in that direction. So the need [for COVID-19 tests] will be extremely high," he added.
The approval of the rapid antigen test in Europe comes as the continent experiences a worrying resurgence in coronavirus cases.