British lateral flow tests BANNED in UK despite being cleared by EU

British-made lateral flow tests are BANNED in UK despite being cleared for use in EU… leaving the government relying on swab kits from CHINA

  • British manufacturers reportedly frustrated with strict UK new checks on tests
  • Only one British firm – SureScreen – is cleared to supply lateral flow tests to UK
  • Government relies heavily on two Chinese companies to fill testing requirement 

The Government is relying on Chinese suppliers for lateral flow testing kits because most British manufacturers have failed to be cleared for use in the UK, it has been claimed.

Despite millions of pounds of investment to create a world-leading testing programme in the UK, only one British manufacturer has produced a rapid test that meets UK requirements, reports suggest.

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

The newspaper reports that Omega Diagnostics, 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 in receipt of government funding after signing contracts in March 2021, the Sunday Times reports, and it is understood the Government is now asking for £2.5million to be repaid by Omega.

The Government is relying on Chinese suppliers for lateral flow testing kits because most British manufacturers have failed to be cleared for use in the UK, it has been claimed

Flowflex, made by Chinese manufacturer Acon Biotech, is one of the approved tests in the UK

The delays in approval comes after new regulations were introduced in November which require tests in the UK to pass the Coronavirus Test Device Approvals.

Tim Peto is a professor of medicine at Oxford University, is on the committee that checks Porton Down’s assessments of tests.

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.’

British-made tests are now being sold abroad because they are unable to get certification for use in this country.

The main suppliers of NHS lateral flow tests are Chinese brands Orient Gene, made by Zhejiang Orient Gene Biotech, and FlowFlex, made by Acon Biotech, according to the Times, who reports that both companies are more experienced in manufacturing lateral flow testing kits on a large scale compared to British companies.

It comes after the Government came under fire for a widespread shortage of testing kits over the Christmas period.

Despite ministers urging friends and families to get tested before socialising over Christmas and New Year, people struggled to get hold of kits.

The Government’s website frequently suspended the delivery of home tests while walk-in appointments for PCR tests were regularly booked up.

Orient Gene Biotech, a Chinese firm, is one of two major approved manufacturers in the UK

SureScreen is the only British manufacturer to have received Government approval for tests

Pharmacists called on the Government to increase its supply as they said they were being forced to turn customers away empty-handed due to a lack of stock.

In response to the backlash, the UK Health Security Agency insisted it had increased its capacity to enable the delivery of 900,000 testing kits a day.

Meanwhile, Sir Roger Gale, Conservative MP for North Thanet, said he had been told by the Health Secretary there was a ‘world shortage’ of testing supplies.

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 MP for North Thanet added: ‘The British company making them has cranked up its production by four times and is now producing 20million a week instead of five million. We the Brits are buying all those, plus anything else we can get our hands on, but we are competing with everybody else on a worldwide market.’

Pharmacists last week urged the Government to increase its supply of lateral flow testing kits as they said they were being forced to send people away empty-handed due to a shortage

The only approved British supplier of lateral flow devices is Derby-based SureScreen Diagnostics who were officially announced in September.

The Government championed the company, saying it had created more than 370 jobs in the Midlands and that it has the capacity to manufacture 7million tests per week with plans to increase this to 14million 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.

‘SureScreen, a British manufacturer, has committed to supplying 20 million lateral flow tests.’ 

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