RSS urges new Covid-19 testing standards

The RSS’s working group on diagnostic tests is calling on the Medicines and Healthcare Products Regulatory Agency (MHRA) to review and revise the national licensing process for diagnostic Covid-19 tests to ensure public safety is protected and evidence of the tests’ performance is available.

Currently, the law does not require tests to be evaluated in the settings in which they will be used nor for the evidence to be publicly scrutinised.

The RSS said that tests have come to the market during the pandemic without any evidence of their accuracy, and said any assessment of a test’s safety should extend beyond the safety of the device to the consequences of false negatives and false positives.

Lateral flow tests, for example, have been tested in laboratories, but have missed cases when used by non-healthcare professionals in mass testing programmes.

The RSS working group said that prevalence of Covid-19 should be used to determine when to change or stop using tests, and called for more transparency around testing, including informing the public that a negative test does not rule out Covid-19 infection.

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-19, 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.”

Professor Jon Deeks, co-chair of the RSS working group on diagnostic tests, said: “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.”