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Hospital Healthcare Europe
Hospital Healthcare Europe

Public Health England approves coronavirus antibody test

14 May, 2020  

A test has been approved by Public Health England (PHE) to test whether a person has antibodies to coronavirus.

The test called Elecsys®, developed by Roche, is an immunoassay for the detection of antibodies to SARS-CoV-2 in human serum and plasma and is a highly reliable marker of past infection.

The manufacturer’s information sheet cites a sensitivity of 100% (95% confidence intervals, CI, 88.1. – 100%) when used in patients 14 days after confirmed infection with COVID-19. It also has an overall specificity of 99.81% (95% CI 99.65 – 99.91%).

In the US, the FDA issued an Emergency Use Authorisation for Elecsys® on 3 May, which allows the test to be used during public health emergencies and, in the UK, the accuracy of the test has been confirmed by experts at PHE’s Porton Down facility. It is hoped that the test will enable the National Health Service to undertake hundreds of thousands of tests every week.

The purpose of antibody testing is to determine whether someone has been previously infected with coronavirus and is likely to be immune and so can return to work and thereby speed up the easing of the lockdown measures.