UK antibody testing rollout awaiting regulatory approval

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The government blocked the wider rollout of antibody testing, prompting companies to voice frustration at being left out of what was being sold as an inclusive and “global” diagnostic market.

Formerly heralded by Boris Johnson as a ‘game changer’ in efforts to lift lockdowns in the UK, the number of government-issued antibody tests has fallen to its lowest level since the start of the crisis, rising from more than 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 are being rolled out for nursing home residents and patients, and later millions for the general public, antibody testing is currently only offered. frontline medical personnel.

The UK government has maintained tight control over regulatory approval of tests and set a bar of 98% for their accuracy, meaning very few of them make it to the 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 demands.

“We failed to test people for the coronavirus the first time around and now we are unable to tell them whether they had it or not,” said Jon Deeks, professor of biostatistics at the university. from Birmingham and lead author of an ongoing study of antibody testing by Cochrane, the independent world health organization.

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

The World Health Organization has set a significantly lower bar for the accuracy of rapid antibody tests than the Medical Health Regulatory Authority. WHO requires 90% sensitivity, identifying all real cases and avoiding false negatives, and 97% specificity, recognizing only real cases and avoiding false positives.

The government-backed UK Rapid Test Consortium, a partnership between the University of Oxford and diagnostic companies, has produced a 20-minute antibody test and is awaiting approval from the MHRA – as are its investors.

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

The consortium claimed its test was found to be 98.6% accurate in “secret human trials” but did not make the data publicly available, causing frustration among diagnostic researchers and competitors. .

“We have this eggs in a basket approach for a miracle test and we have no evidence that it is a miracle test,” Prof Deeks said, adding that the government “has backed a horse before His birth”.

In April, the government said it was “calling on all UK life science companies to devote their resources to creating and deploying large-scale mass testing” in what was billed as Pillar 5 of its testing strategy to create a ”Diagnostic Industry.

But many companies that have responded to the government’s call have felt left out and unable to gain regulatory approval in the UK. These include Mologic and SureScreen Diagnostics, which sells its rapid test in 53 countries and has obtained regulatory approval from Belgium and France.

“From our perspective, we know we have one of the best products on the market, with 97% specificity,” said David Campbell, director of SureScreen. “We know it’s good, we have exported a lot and we are there and ready at all times [the UK government] wants to engage with us. ”

A spokesperson for the Ministry of Health and Social Affairs said: “Antibody testing is a central part of the government’s testing program – over 1.4 million tests have been performed and continue to play a role. crucial in building our understanding of the spread of the virus.

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

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