British-made lateral flow tests banned in UK despite test shortage and EU approval


The Government refused to bring in restrictions during the festive period due to the rapid spread of the Omicron and instead people were urged to take a test before socialising – but many people are struggling to get their hands on these rapid test kits

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The Government is relying on lateral flow testing kits from China because British manufacturers have not been cleared for use in the UK, it is claimed.

Reports suggest that there is only one British manufacturer that has produced a rapid test which meets UK requirements.

This is despite millions of pounds being injected into creating a world-leading testing programme in the UK.

The revelation comes as thousands of Brits scrambled to find a lateral flow testing kit over the Christmas and New Year period, but were unable to due to a shortage.

The Government refused to bring in restrictions for England during the festive period despite the rapid spread of the Omicron, and instead, people were urged to take a test before socialising.

The Government is relying on lateral flow testing kits from China
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But they were frequently unavailable on the Government website and pharmacists pleaded for an increase in supplies as they said they were forced to send people away empty-handed.

This comes as official figures revealed nearly one in 10 NHS workers were off sick over New Year’s Eve as the virus continued to hit the health service.

Several British companies are frustrated that despite their tests being certified for use in Europe, they have not passed checks in the UK, the Sunday Times reports.

New regulations were introduced in November which require tests in the UK to pass the Coronavirus Test Device Approvals.

Millions of pounds being injected into creating a world-leading testing programme in the UK
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The newspaper said that Omega Diagnostics, which is based in Stirling, and Global Access Diagnostics, a Bedford-based firm, have produced testing kits that did not pass regulation and so the Government has not placed any orders with them.

Both companies were given funding after signing contracts in March 2021, the Sunday Times reports, and it is believed the Government is now asking for £2.5million back from Omega.

Tim Peto is a professor of medicine at Oxford University, is on the committee which checks the assessments of tests at the top-secret Government laboratory Porton Down.

He told The Times: “Some of the English manufacturers are very unhappy their kits have failed and some of them think that they’ve been unfairly tested. I don’t know on what grounds they think it’s unfair other than it came out negative.”

There is a shortage of the kits in the UK
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The main suppliers of NHS lateral flow tests are Chinese-based Orient Gene, made by Zhejiang Orient Gene Biotech, and FlowFlex, made by Acon Biotech, according to The Times.

They are claimed to be more experienced in manufacturing lateral flow testing kits on a large scale compared to their British counterparts.

The Government website continues to frequently tell people there are no home deliveries available for lateral flows but the UK Health Security Agency has insisted people check the site regularly.

When the Mirror tried on Monday afternoon the website said: ” Sorry, there are no home delivery slots left for rapid lateral flow tests right now.”

The Government website continues to frequently tell people there are no home deliveries available

The UKHSA insisted it had increased its capacity to enable the delivery of 900,000 testing kits a day.

But Sir Roger Gale, Conservative MP for North Thanet, said he had been told by the Health Secretary Saiid Javid there was a ‘world shortage’ of kits.

He told MailOnline last week: “Originally it was a delivery problem, now it’s a supply and delivery problem.

“[ Sajid Javid ] was very upfront and straight about it. He said there is a world shortage of lateral flow tests.”

The UKHSA insisted it had increased its capacity to enable the delivery of 900,000 testing kits a day
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The only approved British supplier of lateral flow devices is SureScreen Diagnostics in Derby who were officially announced in September.

The Government said the company had created more than 370 jobs in the Midlands and that it has the capacity to manufacture seven million tests per week with plans to increase this to 14 million by the end of December.

The UKHSA said: “In building the largest diagnostic industry in UK history, we have delivered 400 million tests since the start of the pandemic, playing a vital role in tackling the spread of Covid-19.

“NHS Test and Trace has drawn on expertise from across the public and private sectors and all contracts are awarded in line with procurement regulations and transparency guidelines.

Pharmacies across the country have run out of kits
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“SureScreen, a British manufacturer, has committed to supplying 20 million lateral flow tests.”

As pharmacies across the country run out of kits, a number of people have taken to selling them at a premium online with an auction house even flogging job lots.

One of the tests has been listed for a huge £100 ahead of New Year’s Eve celebrations.

Simon Charles Auctioneers and Valuers had four job lots of testing kits up for auction on its website on Thursday morning.

Each lot contained either 15 or 20 kits and had each received bids of around £5 as of 2pm this afternoon.

Simon Charles Auctioneers were approached by the MEN about the auctions but did not provide a comment at the time of publication. They couldn’t be reached by phone when The Mirror contacted and have been contacted via email.

Meanwhile, one person on Facebook was selling lateral flow tests for £5 each.

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George Holan

George Holan is chief editor at Plainsmen Post and has articles published in many notable publications in the last decade.

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