UK approves 'game changer' coronavirus antibody test
Blood test samples. /VCG
Blood test samples. /VCG
The Public Health England has approved a coronavirus antibody test developed by Swiss drugmaker Roche Holding AG to detect if a person has had been infected by the COVID-19.
The British government said it was talking with Roche on rolling out its test after a Public Health England laboratory at Porton Down, in Wiltshire, concluded it had 100-percent specificity. That means it can detect antibodies to the exact disease rather than similar ones.
"This has the potential to be a game changer," said Edward Argar, Britain's junior health minister.
"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.
Before the Porton Down laboratory's results, the United Kingdom had said no COVID-19 antibody test was accurate enough to use.
"This is a very positive development because such a highly specific anti-body test is a very reliable marker of past infection," said John Newton, national coordinator of the UK Coronavirus Testing Program.
"Scientific experts at PHE Porton Down carried out an independent evaluation of the new Roche SARS-CoV-2 serology assay in record time, concluding that it is a highly specific assay with specificity of 100 percent."
Roche said late on Wednesday it was in talks with the National Health Service and the UK government about a phased roll-out of antibody test kits as soon as possible and would be able to provide hundreds of thousands of the test kits per week.
"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."
TheTelegraph, which first reported the findings, said the government was in negotiations with Roche to buy millions of kits.