Half a million Covid-19 test kits from major government suppliers are recalled "after random samples have shown that they are not sterile."
- Nursing homes and the public should immediately stop using Randox swabs yesterday
- Concerns were raised when the Chinese supplier lacked paperwork
- During physical examinations, swabs were found to be non-sterile, which led to concerns about their reliability
Half a million coronavirus tests used by thousands of Britons have been recalled after sampling showed that they were not sterile, it was claimed today.
The Department of Health yesterday instructed nursing homes and the public to stop using the kits manufactured by Randox Laboratories.
More than 500,000 swab kits have been pulled out of fear they could give Britons who fear the disease will have unreliable consequences.
Health bosses have refused to reveal how many Britons used them before they were recalled, but the Northern Irish company is one of the main suppliers of tests in the UK.
At the start of the crisis, Randox was awarded a £ 133 million contract to conduct Covid-19 tests at home and tests carried out in transit centers and nursing homes.
As part of the business, swabs are brought into people's homes, nursing homes and testing facilities and returned to Randox for processing and diagnosis in the laboratories.
The manufacturer's tests are likely to make up a large part of the 150,000 swabs that are performed daily in the UK.
Concerns about the safety of the tests were raised on Wednesday when it emerged that a Chinese company that supplies Randox with the swabs had not provided any security documents. This prompted the UK to physically inspect the kits.
Coronavirus tests conducted by Randox Laboratories have been withdrawn due to concerns that they are not safe
A health source told the sun: “Samples showed that the swabs in the kit were not sterile. This means that samples from patients can be contaminated, which affects the results.
"Although the risk to the public is low, half a million have been withdrawn as a precaution."
The manufacturer of antibody tests, who made the kit in March, has not yet approved it from Public Health England
A manufacturer of a powerful Covid-19 antibody test has still not managed to get it approved by officials for use in England – although it has demonstrated months ago that it works better than others on the market.
SureScreen Diagnostics from Derby first developed a rapid antibody test that tests blood to determine if someone has already had Covid-19 and has delivered results in just 10 minutes since March.
Despite repeated attempts to get the public health England-approved test, which looks like a pregnancy test, to use in NHS hospitals, the company still hasn't had any success.
But while SureScreen has been waiting, giant pharmaceutical companies in Switzerland and the United States have approved their tests – which the company claims are not working well – by PHE and bought millions of dollars from the Department of Health.
The rapid tests are based on fingerprint blood and are from a kind of minister who appears to have gotten cold after the government wasted £ 20m in the region for those from China who turned out not to be good.
None of the tests, including those from SureScreen, have gone through the PHE approval process, with officials instead focusing on laboratory-based ELISA tests that use vein blood.
Meanwhile, the Department of Health has spent millions of pounds on seven different types of laboratory tests, most of which reviews have shown to be less accurate than the SureScreen test.
David Campbell, director of SureScreen, told MailOnline that the company had not signed a large government contract, but only granted PHE approval to sell its tests, which can be bought privately for £ 18, to hospitals. In comparison, tests by the US company Abbott online cost over £ 45 each.
Health minister Matt Hancock informed the House of Commons yesterday evening that nursing homes and test centers that had found themselves using Randox tests were instructed to discard them and replacements would be sent to them.
Mr. Hancock reiterated that withdrawing the tests was "a precautionary step" and that there was "no evidence" that the swabs could do harm.
He also claimed that thousands of Britons who have already taken a Randox test should not be worried as this does not affect their results.
The health minister said: “We have identified some swabs that are not of the usual high standard that we expect and we will continue to test this lot as a precaution.
& # 39; And as we continue to investigate, we request that the use of these Randox swab test kits be suspended in all settings until further notice.
& # 39; Clinical advice is that there is no evidence of harm, the test results are not affected.
"There is no evidence of problems with our other test smears, and there is no impact on access to tests."
A Randox spokesman said, "As an immediate precaution, we have temporarily suspended distribution of sample collection kits at home using a specific lot / swab supplier.
& # 39; This is a temporary measure and does not apply to our private business, which uses a different swab provider. Randox kit test results are not affected. & # 39;
Randox won the second largest test order in the UK, just behind the US company Hologic, which closed a £ 151 million deal.
Randox received an order from the Ministry of Health to produce test kits that increased the government's capacity to handle 100,000 swabs a day in April.
The government was criticized for the Randox deal after it was announced that Tory MP Owen Paterson would receive a six-figure salary from the company to act as a consultant.
Randox # tests can produce results in a matter of hours, and machines that analyze the swabs can process 54 samples at a time.
The Telegraph reports that this is not the first time that problems with Randox testing have occurred during the British fight against Covid-19.
In May, a machine in the company's Antrim laboratory stopped working and the UK had to send tens of thousands of samples to a laboratory in the United States.
But almost 30,000 of the swabs had to be thrown away because it was taking too long to arrive.
Samples must be tested within 72 hours of performing the test. This means that if processing delays occur, people with symptoms may be unsure if they have the virus.