Recommendations designed by a group of RSS experts, to reframe the evaluation of in vitro diagnostic tests (IVDs) have been published in our Series A journal.
The report, which is an update of a 2021 version, is intended to help prevent future scenarios in which IVDs are marketed widely, but later attract serious concerns about the standards applied to their evaluation.
The research, which will be shared with the UK Covid Inquiry, was prompted by concerns about the standards applied to the evaluation of diagnostic tests during the pandemic – particularly lateral flow tests – however the report’s 22 recommendations cover all new tests, especially those designed to detect infectious diseases.
A working group of statisticians, co-chaired by former RSS president, Professor Deborah Ashby and Professor Jon Deeks from the University of Birmingham, collaborated on the report with co-authors from the Universities of Oxford, Cambridge, Edinburgh, Birmingham and the London School of Hygiene and Tropical Medicine.
RSS president, Dr Andrew Garrett, commenting on the publication, said: ‘The report provides a thorough evaluation of both diagnostic tests and diagnostic testing. It addresses how to develop, regulate, and use diagnostic tests in the future – a subject that is of increasing importance to individual and public health.’
Read the report in RSS Series A