More work needs to be done to evaluate current Covid-19 tests, leading statisticians have said.
Experts from the Royal Statistical Society (RSS) said that current legislation does not require the tests to be assessed in the setting where they will actually be used.
The RSS warned that tests have come to market without evidence of their accuracy for many of the uses to which they are being applied.
It has called on the Medicine’s and Healthcare products Regulatory Agency (MHRA) to review its licensing process for some diagnostic tests.
Statisticians claimed that during the pandemic there have not been the necessary evaluations of tests for the different uses to which they are applied.
For instance, one brand of commonly used lateral flow tests was tested in a laboratory setting among patients with symptoms.
Now they are being used in homes around the country, with people urged to test themselves twice weekly to make sure they are not asymptomatically carrying the virus.
But the efficacy of the tests has not been assessed for use in this way, the RSS suggested.
Professor Deborah Ashby, co-chair of the RSS Working Group on Diagnostic Tests, said: “Testing has been a key focus of many government’s strategies in fighting Covid, but the lack of statistical standards has caused issues, with tests coming to market without enough known on their effectiveness.
“We urge regulators to take on board our recommendations, to allow for more scrutiny of diagnostics more generally and for future pandemics.”
Co-chair Professor Jon Deeks added: “While no one questions the need for an evidence-based approach to vaccines and treatments, the proper assessment of the suitability of Covid-19 tests has been neglected.
“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.”
The MHRA’s director of devices, Graeme Tunbridge, said: “We are currently considering changes to the framework for the regulation of diagnostics in Great Britain.
“In the coming months we’ll be consulting with the scientific community, health care professionals, manufacturers and the public to inform the design of this future framework.
“We would encourage all interested parties to respond to the public consultation.”