Galapapositief schreef op 9 december 2020 17:48:
www.ft.com/content/7c0d1d5b-f746-4c50... A rapid coronavirus test developed in the UK is close to gaining approval for use by health authorities in England in a boost for the government as it seeks to roll out more mass testing.
The antigen, or lateral flow, test produced by the Derby-based company SureScreen Diagnostics has shown positive results in clinical studies undertaken by researchers at Public Health England and Oxford university, according to two scientists involved in the review.
“We’re delighted about it, it looks like [they] have the real deal,” one of the people said.
Unlike conventional PCR tests, which look for the virus’s genetic material and can take up to a day to process, lateral flow tests do not need to be analysed in a laboratory and can deliver a result in up to 30 minutes. The tests look for protein antigens that live on a virus’s surface, and work by adding a liquid reagent to a saliva or nasal swab sample.
Finding a UK producer has been a priority for the government, which is eager to ensure a reliable supply of rapid tests after it has become harder to procure them from the US and China.
Boris Johnson, UK prime minister, last month told the BBC he had been in discussions with scientists from Public Health England who had seen “real progress on a UK-made lateral flow test” but did not identify the manufacturer.
Some experts have questioned whether lateral flow tests are accurate enough, with some studies suggesting they pick up less than half of active infections when used in the community.
David Campbell, a director at SureScreen, insisted that the sensitivity of SureScreen’s test — its ability to detect infection — was “very high”, while its specificity — the ability to detect only the virus and not deliver a false positive — was close to 100 per cent.
He added that he could not comment on the results of the confidential clinical studies but hoped the company would be able to boost the UK’s rapid testing capacity. “With global demand for these kinds of tests so high, it’s important we have a good quality supply out of the UK,” he said. “If we can support that in any way, that’s great.”
The Department of Health and Social Care declined to comment on the SureScreen test. “Public Health England continue to review a number of these devices against strict criteria and will confirm the results when available,” it said.
The government has spent at least £1.8bn on lateral flow testing technology, according to publicly available contracts, more than half of which has paid for tests from US company Innova. Two new tenders for rapid tests were issued last month, each worth a total of £912m.
So far the UK has bought about 500m lateral flow tests, mainly from Innova and two other US manufactures, Abbott and Tanner Pharma, according to a person with knowledge of the procurement process.
Rapid tests were “flying off the shelves”, making it increasingly difficult to procure large consignments from the major international suppliers, the person said, asking not to be identified. The UK’s current stocks from international suppliers are set to run out by February, they added.
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Lateral flow tests, which tend to cost between £5 and £20, are central to the government’s mass-testing strategy, which started last month in Liverpool, where 153,000 people were tested within the first two weeks, regardless of whether or not they had symptoms.
Under the latest phase, lateral flow tests are being rolled out across communities in areas of the country designated as tier 3, such as Kent, in addition to being offered to care home residents and their visitors, as well as at many universities across the country.
Founded in 1991, family-run SureScreen produces technology to screen for drug abuse, infectious disease and other illnesses. The company already sells its Covid-19 rapid antigen test to countries across Europe, including Belgium and Germany.
It has capacity to produce several million tests per week, with plans to expand further by the end of the year.