Call for new standards12 Jun 2021 13:28
Experts call for new standards for diagnostic tests to address testing problems during the COVID-19 pandemic
The Royal Statistical Society (RSS) has today published its review of the statistical evidence needed to assure the performance of future diagnostic tests, so we are better prepared for future pandemics.
The RSS Working Group on Diagnostic Tests, which is co-chaired by University of Birmingham’s Professor Jon Deeks, is calling on the Medicines and Healthcare Products Regulatory Agency (MHRA) to review and revise the national licensing process for in vitro diagnostic tests, to ensure that reliable evidence about the performance of tests is available and public safety is protected.
Present legislation does not require tests to be evaluated in the settings where they will be used, and for the evidence to be independently scrutinised and publicly available. Currently, the performance of diagnostic tests is not held to a common statistical benchmark in either the UK, US, or EU, whereas the regulatory regime for drugs and vaccines is more stringent. Covid-19 has brought this longstanding problem to the fore, as tests have come to market without evidence of their accuracy for many of the uses to which they are being applied and have been marketed with claims not supported by strong studies.
The RSS experts stress that the assessment of a test’s safety must go beyond just the safety of the device itself, to include the potentially harmful consequences of false negatives and false positives.
“Investment in well-designed studies evaluating tests in the real-world settings where they are used must become standard practice. We must learn from the mistakes made during the pandemic and put in place requirements for stronger science, better regulation and more transparency.”
https://www.birmingham.ac.uk/news/latest/2021/06/covid-diagnostic-tests-problems-new-standards.aspx
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