A new Covid-19 test that provides results in 15 minutes from Becton Dickinson and Co. has been approved for use in countries that have Europe’s “CE” marking.
“CE marking is an administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.”
Fernand Goldblat, Becton Dickinson’s head of diagnostics for Europe, said “It is really a game-changing introduction here in Europe.” Back in April and May of this year, Europe was the epicenter of the pandemic. Goldblat says, “Unfortunately I think we’re headed back in that direction. So the need will be extremely high.”
The test will likely be sold to and used by emergency departments, doctors, and pediatricians. A downside to these tests is that they are not as accurate as the PCR diagnostic assays which are the norm. These are Polymerase Chain Reaction assays, and test for the virus at a molecular level. The tests run on their Veritor Plus System, which costs about $250-$300, and each test costing about $20.
“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.”
Becton Dickinson already has the test available in the United States and says they are on track to produce 12 million units monthly by March of 2021.
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