Europe adopts 'game-changing' 15-minute COVID test

The US-developed rapid antigen test will be available from the end of October.

By Bloomberg News, September 30 2020
Europe adopts 'game-changing' 15-minute COVID test

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.

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.

The data, which differ from the U.S. label’s 84% sensitivity and 100% specificity, come from a new clinical study that was recently submitted to the U.S. Food and Drug Administration, spokesman Troy Kirkpatrick said.

European inroads

Rapid antigen testing has been making inroads in Europe as well as the U.S. Roche Holding said this month it would launch its own 15-minute antigen test to European markets accepting the CE mark.

Another test developer, LumiraDx, received CE marking for its antigen test late last month. It said it planned to manufacture 2 million tests in September and as many as 10 million in December.

Becton Dickinson’s Veritor system has been used largely to screen for flu in Europe to date, but the new assay could help drive wider antigen testing adoption, including for influenza and other respiratory viruses, said Goldblat.

The company is currently having conversations in multiple European countries, largely with governments and health authorities, about “where and how our solutions would fit,” he said.

The test is already available in the U.S. Becton Dickinson said it is on track to produce about 8 million each month by October across its global markets, and 12 million monthly by March 2021.

Goldblat declined to comment on how those tests would be allocated in Europe and the U.S., except that “a good portion” would be coming to Europe. Pricing will depend on commitments made and the reimbursement environment in a given country, among other factors, he said.

In the U.S., where regulators cleared the assay in July, the Veritor Plus System has an average selling price of US$250- $300, and the tests themselves are about US$20 each.

Also read: Airlines look to rapid pre-flight COVID tests to kick-start travel

This article is published under license from Bloomberg Media: the original article can be viewed here

Qantas

19 Apr 2012

Total posts 1051

Yes but what is the false negative rate for asymptomatic people they are not telling us that.

07 May 2020

Total posts 62

The northern hemisphere is moving ahead rapidly with managing how to live with covid. This test is just one of the resources developed to help with this management. The northern hemisphere is NOT even trying to follow an elimination strategy like those in the southern hemisphere such as Australia and NZ. So a small % of false positives or negatives is acceptable. Only those nations trying to achieve elimination need 99.99% guarantee about tests, otherwise they cannot take the risk. It is going to be interesting to see how these "elimination" nations are going to manage when a vaccine comes along that only has a 60-80% efficacy. This is going to be even too risky for them to rely upon in order to open up. So please pray for Australia and NZ that the Scomo Vaccine he is promoting is 99% effective.

Qantas

19 Apr 2012

Total posts 1051

GoRobin not sure northern hemisphere is learning to live with COVID with widespread lockdowns of varying severity across Europe. The lockdowns in Europe are much the same as Australia but with a higher threshold such as a 1% incidence rate. The Australian strategy is not elimination but suppression to less than around 10 cases a day which is manageable without widespread lockdowns. 

It is not a small percentage of false negatives these tests have but as high as 40% with asymptomatic people, worse than useless. The rapid tests are great for triaging sick people in emergency departments as it is accurate with people with symptoms but without just a money maker for testing companies and a danger for instilling complacency in people.


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