Rollout of UK’s antibody tests still awaiting regulatory approval

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The government has stalled the wider rollout of antibody tests, causing companies to voice frustration at being kept out of what was sold as an inclusive and “world-beating” diagnostics market.

Once heralded by Boris Johnson as a “game-changer” in efforts to lift lockdown measures in the UK, the number of antibody tests being issued by the government has fallen to its lowest level since the beginning of the crisis, from over 40,000 a day in June to 5,000 a day over the past month. 

Despite earlier claims that tens of thousands of antibody tests would be rolled out to care home residents and patients, and later millions to the wider public, antibody tests are currently still only being offered to frontline medical staff. 

The British government has kept a tight grip on regulatory approval for the tests, and set a bar of 98 per cent for their accuracy, meaning very few make it to market. In July, two of the biggest antibody tests supplied to the UK — Abbott’s and Roche’s — were found not to meet the government’s own requirements.

“We failed to test people for coronavirus the first time round and now we’re failing to be able to tell them whether they had it or not,” said Jon Deeks, professor of biostatistics at Birmingham university and lead author of a continuing review into antibody testing by Cochrane, the independent global health organisation.

He noted that tests produced in the UK are being sold overseas in the millions. “Why aren’t they available here? There’s no good reason why they aren’t,” he added.

Column chart of Number of antibody tests provided in Pillar 3 of government testing strategy showing Daily antibody tests hover around 5,000 for weeks

The World Health Organisation has set a significantly lower bar for rapid antibody tests’ accuracy than the Medical Health Regulatory Authority. The WHO demands 90 per cent sensitivity, identifying all real cases and avoiding false negatives, and 97 per cent specificity, only recognising real cases and avoiding false positives. 

The government-backed UK Rapid Test Consortium, a partnership between Oxford university and diagnostics firms, has produced a 20-minute antibody test and has been awaiting approval from the MHRA – as have its investors.

The four companies in the consortium — Abingdon Health, Omega Diagnostics, BBI Solutions and CIGA Healthcare — aim to supply 1m tests to the government per week by the end of November. 

The consortium claimed its test was found to be 98.6 per cent accurate in “secret human trials” but has not made the data publicly available, leading to frustration among diagnostics researchers and competitors.

“We’ve got this eggs-in-one-basket approach for a miracle test and we have no evidence that it is a miracle test,” said Prof Deeks, adding that the government “backed a horse before it was born”. 

In April, the government said it was “calling on all British life science companies to turn their resources to creating and rolling out mass testing at scale”, in what was pitched as Pillar 5 of its testing strategy aimed at creating a “world-beating” diagnostics industry. 

But many of the companies that heeded the government’s call have been left feeling sidelined and unable to gain regulatory approval in the UK. These include Mologic and SureScreen Diagnostics, which is selling its rapid test to 53 countries and has gained regulatory approval from Belgium and France.

“From our point of view we know we’ve got one of the best products on the market, with 97 per cent specificity,” said David Campbell, director of SureScreen. “We know it’s good, we’ve exported a lot, and we’re here and ready whenever [the UK government] wants to engage with us.” 

A Department of Health and Social Care spokesperson said: “Antibody testing is a central part of the government’s testing programme — over 1.4 million tests have been conducted and it continues to play a crucial role in building our understanding of the spread of the virus.

“We are working with health experts and industry to develop the reliable, accurate antibody tests which could potentially help us control the spread of this virus.”

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