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UK follows EU, U.S. to approve Roche COVID-19 antibody tests

LONDON (Reuters) – Britain is in talks with Swiss drugmaker Roche Holding AG (ROG.S) to buy an accurate COVID-19 antibody test, following the lead of the European Union and United States, which had already given preliminary approval to the tests.

Mass antibody testing with millions of kits is being considered by many countries as a way to speed the reopening of economies devastated by the lockdowns and social distancing measures put in place to slow the spread of the new coronavirus.

A Public Health England laboratory concluded on May 7 that the Roche test detected the exact antibodies prompted by the virus, but the findings were only made public late on Wednesday.

“This has the potential to be a game changer,” Edward Argar, Britain’s junior health minister said on Thursday.

“We are now moving as fast as we can to discuss with Roche purchasing of those but I can’t give you an exact date when we’ll be able to start rolling them out.”

The Roche test received a conformity assessment, known as Conformité Européenne, or CE mark, from the European Union on April 28 and received Emergency Use Authorization from the U.S. Food and Drug Administration on May 2.

Roche said it was able to produce hundreds of thousands of the tests per week for the United Kingdom. Germany is getting three million of them this month, and five million a month after June.


The antibody tests – also known as a serology test – show who has been infected, although it is not yet clear whether the presence of antibodies to the new coronvirus, SARS-CoV-2, confers permanent immunity.

They require a blood test that can be run on fully-automated equipment in laboratories to provide results in just 18 minutes.

Britain’s health ministry did not answer questions about how many tests it has ordered.

“We are exploring the use of antibody testing across the NHS and ultimately the wider public,” a ministry spokesman said, adding that the government was “actively working on our plans for rolling out antibody testing”.

Similar antibody tests have also been developed by companies including U.S.-based Abbott Laboratories and Italy’s DiaSorin. Abbott (ABT.N) and Germany’s Siemens Healthineers (SHLG.DE) have separately laid out plans to produce 20 million tests or more per month for the global market from June.

Based in Basel, Switzerland, Roche said it is ramping up capacity to produce high double digit millions of tests per month to serve countries accepting the CE mark and the United States.

“The test requires a blood sample to be taken by a qualified healthcare professional and processed in a laboratory,” Roche said, adding that it was one of the most accurate tests on the market with over 99.8 specificity.

“This level of accuracy is vitally important because there are a number of viruses with very similar antibodies to Covid-19, including the common cold, and other SARS strains, which can produce a positive result in some less accurate antibody tests.”

The Daily Telegraph newspaper, which first reported the findings, said the government was in negotiations with Roche to buy millions of kits.

Reporting by Aakriti Bhalla and Aishwarya Nair in Bengaluru, John Miller in Zurich and Kate Holton and Guy Faulconbridge; Editing by Shailesh Kuber and Philippa Fletcher

Our Standards:The Thomson Reuters Trust Principles.

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