A rapid corona virus test at the center of Boris Johnson’s mass-testing strategy missed more than 50% of positive events Operation Moonshot Pilot In Greater Manchester, the Guardian can reveal.
During a landmark test in Manchester and Salford last month, 20-minute trials, which cost $ 323 million to use with hospital and nursing home staff, identified only 46.7% of infections.
What this means is that many of those who carry Covit-19 have been misrepresented as being free of the virus, which can infect others.
This is one of the tests to be used in the UK’s first city-wide mass testing effort Starts Friday in Liverpool. It has also been sent to several hospitals in the UK.
Scientists with the Mass Trial Expert Group (MTEG) in Greater Manchester raised significant concerns this week about the accuracy of optigen direct RT-light tests, and said the technology should not be widely used in hospitals or nursing homes.
These findings raise significant questions about one of the key tests of the government’s mass-screening strategy, which Johnson returned to default as the UK’s main route this week. The Prime Minister told MPs on Monday that “we will test all NHS staff as soon as possible” and would like to introduce rapid, routine testing of hospitals, nursing homes, schools and universities.
The first phase of the Salford test was charged Operation Moonshot The mass testing program was but Strictly measured Six weeks later, due to concerns about the accuracy of the optigene test, the Guardian understands.
Local leaders had asked the government for medical validity data behind the technology, but it is understood this data was not provided.
Department Health Social Care said the test was validated in three different tests from Manchester’s findings, although it did not disclose the data.
Reporting to regional health leaders and Greater Manchester (GM) Mayor Andy Burnham, MTEG conveyed their concerns about Operation Moonshot findings to Martin Britsard, chairman of the region’s experimental strategy team, on Monday.
In a letter to the Guardian, they wrote: “Data currently available from the Manchester pilot shows the lowest sensitivity (46.7%) of the direct RT-lighting site, which is preferred for use in hospitals in about 20 minutes.”
Using technology, they wrote that “a high proportion of samples collected from infected individuals will not be detected” and added: “MTEG has significant concerns and does not feel that the data support large-scale investment. -Lamp saliva test. ”
Greater Manchester experts said, “The system’s technical limitations are also a cause for concern,” adding that “these bugs can pose a significant risk if left unchecked.” They added: “It should be noted that solutions to these problems are not available at this time and may take considerable resources and time to resolve.
“There is also concern about the need for the amount of investment [at a ‘new department’ level] Using this test to the extent that it is effective and consistent is unlikely to be cost effective.
“We are fully committed to extensive asymptomatic testing in the healthcare and maintenance sectors, but we do not believe this is the right platform for widespread use across GM.” Experts said they would re-evaluate the tests if there were “material-enhancing sensitivity” corrections.
The clinical trial is being conducted by Optigen, a small biomedical company in Horsham, Sussex. The government has paid Rs 3,323 million for the newly built 600 Genie HD machines and 90m test equipment and chemicals. Each machine can deliver up to 200 tests per hour.
The DHSC confirmed that Genie HD machines will be the primary technology to test NHS staff and patients who do not have symptoms of the corona virus.
They do so using two methods: a quick direct RT-lamp, a saliva sample is inserted directly into the engine after being secured by warming, and a RNA lamp, which takes longer to process because the nucleic acid must be extracted from the sample.
Professor Mark Wilcox, co-chair of DHSC’s technical verification team, said: “Direct lighting tests used in Manchester have been tested in other laboratories and in real-world testing for use in different systems.
“It is incorrect to say that the tests are low-sensitivity, with the latest pilot showing an overall technical sensitivity of almost 80%, rising to more than 96% in individuals with a high viral load, which is important to diagnose in persons with an infection.
Secretary of Health, Matt Hancock, Optigene tests were announced as a six-week test At the end of May, he said, “we can change the way we control Govt-19 across the country.” However, the results of the investigation were never made public. A separate study Released last month It found that only 67% of infections were detected, which means that one of the three cases was missed, and anyone with a negative test was advised to undergo a separate follow-up test to verify the result.
Optigene referred the Guardian to the DHSC.
Questions have also been raised about the separate rapid saliva test being offered to everyone in the community in Liverpool. General data available on the Innova test are for nose and mouth cloth only, not for saliva tests.
The instructions for use state that “negative results do not rule out SARS-COV-2 infection” and should not be used for treatment results or “infection control results”. The government’s Portton Town Laboratory evaluated the test and approved it in August, but no cloth samples and detailed results have been released.
Johnson previously told Commons that the quickest test to use in Liverpool is “tell me if you’re infected or not and get results within 10 to 15 minutes.” However, the Innova test is for people who already have symptoms and are not allowed to self-study. Any positive case should be confirmed by examination with gold-quality laboratory based PCR cloth.
It is understood that experts, including those in Liverpool, are interested in the effectiveness of the tests selected for use in the pilot program and have asked the government to reassure them. There is concern that doubts about the results will undermine public confidence and affect the will of the people to come forward for testing.
Labor MP for Septan in Mercedes urges urgent release of clinically valid data of the test. Bill Esterson asked the government on Thursday: “It is very worrying that incredible tests are being used. It is important for the Liverpool mass test pilot to succeed. ”