Britain has approved a coronavirus antibody test developed by pharmaceutical company Roche and is now working towards acquiring enough kits for widespread testing.
UK health officials determined the tests were “highly specific,” with an accuracy of 100%, in an independent evaluation, Public Health England (PHE) said in a statement to CNN.
“Last week, 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%,” said Professor John Newton, national coordinator of the UK Coronavirus Testing Programme.
“This is a very positive development because such a highly specific anti-body test is a very reliable marker of past infection,” he said.
“This in turn may indicate some immunity to future infection although the extent to which the presence of anti-bodies indicates immunity remains unclear.”
Scientists believe antibodies provide a degree of immunity from future coronavirus infection, though it has not been determined how long such immunity lasts.
Edward Argar, a UK health minister, said Roche’s test “appears to be extremely reliable” and “has the potential to be a game changer” in a television interview with the BBC.
The British government had entered discussions with Roche about acquiring the tests, Argar said. He added that the government was not in a position to roll out the tests yet, but was working on distributing them as quickly as possible.
Roche has previously said its antibody test can provide a result in approximately 18 minutes. It is an in vitro test, using human serum and plasma drawn from a blood sample, and must then be run in a Roche analyser.
The company’s antibody test has also been authorized by the US Food and Drug Administration.