Lack of assessment and data on private Covid tests poses danger to public health, experts warn
As end of free mass testing looms, commercial products are still not subject to full laboratory examination and citizens cannot access comparative information
With the end to free Covid testing just a few weeks away, experts have warned that the of proper assessment and public data on the reliability of commercially available tests poses a significant risk to public health.
The UK Health Security Agency last year said that, by the end of 2021, it would introduce a “gold-standard” programme of validation for privately offered tests to ensure their safety and accuracy met “at least the same baseline as those procured for the NHS".
This programme was intended to encompass an initial desk-based review, followed by an independent assessment in a laboratory – with any tests that failed either of these two stages being barred from sale in this country.
Following the introduction of the desk-based review in July, test manufacturers can no longer use a CE mark alone to self-certify their compliance with minimum standards.
But independent lab tests – which would prove or disprove manufacturers’ claims about product reliability – are still yet to be introduced.
This is despite an impact assessment that took place October finding "consistent disparities between manufacturers’ claims… for their devices and the actual performance of those devices". Tests distributed through the NHS Test and Trace scheme are subject to a much more rigorous review process, which found that three quarters of products assessed did not meet the necessary standard, the impact assessment said.
Implementing a similarly stringent regime for commercial tests was intended not only to ensure the requisite levels of reliability, but also to generate data on products’ performance that could be published for citizens to allow them to make more informed choices about which tests to buy.
A list of firms that have passed UKHSA’s desk-based review is available on GOV.UK; but there is no precise performance data. And, absent any such process, no information how these products stood up to a full laboratory examination.
This story was exclusively reported by PublicTechnology sister publication Civil Service World, which spoke to a range of experts who voiced their concerns about the potential implications for public health of the lack of testing and public data – with free mass testing to cease at the end of next month.
Deepti Gurdasani, a clinical epidemiologist and statistical geneticist at Queen Mary University of London, said it is “unacceptable that validation and vetting of quality standards is not a requirement for something as important as testing for Covid-19 – where errors can cost lives”.
Prof Sheila Bird, a programme leader at the MRC Biostatistics Unit at the University of Cambridge, says the public “has a right to expect” data on tests’ performance that they can use to decide which to buy.
“It is extremely important that those data are not hidden away from the citizen,” she said. “There is a need now – or certainly prior to April – for all such evaluation data to be put into the public domain so that the public, when they are allowed to choose which seven-pack [of LFTs] to buy, have a basis for making the choice.”
A spokesperson UKHSA said: “Testing will continue to be an important tool in managing Covid-19 and there are comprehensive regulations in place to ensure that the public can have full confidence in the tests they buy. The Coronavirus Test Devices Approval process is one of the most rigorous in the world and ensures that tests on the market in the UK meet strict quality standards.”
Accenture picked as supplier of choice for two-year contract that will cover support and ‘disaggregation’ activities
Long-term contracts cover data from a range of specified departments
Leaders of health department and UKHSA admit to MPs that some meetings with Randox went undocumented
Long-standing to-do list was cleared by recruitment of staff and dedication of resources to focus on key technology areas