Public Health England approves Roche antibody test for Covid-19

Public Health England has approved pharma giant Roche’s antibody test to help determine how many people have been infected by Covid-19.

First reported by The Telegraph, the Department of Health and Social Care are now thought to be in negotiations to purchase millions of the kits.

Roche’s Elecsys Anti-SARS-CoV-2 antibody test was first given the CE mark and was issued Emergency Use Authorisation from the US Food and Drug Administration at the start of May.

The test is said to have 99.8% specificity for Covid-19 and 100% sensitivity, so it will not get confused by other antibodies developed during other illnesses, and will identify any antibodies created due to a Covid-19 infection. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2

The test is based on an in-solution double-antigen sandwich format and its accuracy was determined based on the measurement of a total of 5,272 samples.

Roche had already started shipping the new antibody test to leading laboratories globally and is ramping up production capacity to high double-digit millions per month.

From conversations with the UK government and NHS, Roche has stated it can provide hundreds of thousands tests per week.

Thomas Schinecker, CEO Roche Diagnostics, said: “Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic. Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”

In response to the progress made by UK government, chief executive of the British In Vitro Diagnostics Association, Doris-Ann Williams said: “The government are in the process of revising their testing strategy to cover the next 9-12 months and the IVD industry will continue to support in any way possible but there are questions within the BIVDA membership over apparent pre-selection of laboratory antibody tests from a small number of companies when others with CE marked tests have not been selected for evaluation by Public Health England.”