Rapid roll out of SARS-CoV-2 antibody testing—a concern
Monique Andersson, Nicola Low, Neil French, Trisha Greenhalgh, Katie Jeffery, Andrew Brent, Jonathan K. Ball, Allyson M Pollock, David McCoy, Miren Iturriza‐Gómara, Iain Buchan, Helen Salisbury, Deenan Pillay, William L. Irving
Abstract
We are writing to express concerns over aspects of the establishment of SARS-CoV-2 antibody testing in England. NHS England and NHS Improvement wrote to NHS trusts and pathology networks on 25 May 2020, asking them to offer antibody testing at short notice and ramp up capacity to thousands of samples a day.12 We have three concerns about the request. Firstly, there is no specific clinical indication for the test on an individual basis. Secondly, the performance of these assays has not yet been assessed to the standard typically required of a novel test. And thirdly, the resource implications are not considered. We support the rapid provision of diagnostic tests for individual and public health and recognise the need to deliver at pace. It is essential, however, that quality systems, which have evolved over many years and are the foundation for delivering the right result of the right test to the right person at the right time, are not circumvented. In usual clinical practice, antibody testing fulfils several purposes. In acute illness, an IgM antibody response can be used to diagnose an infectious …