Operation Moonshot: rapid Covid test missed over 50% of cases in pilot

A rapid coronavirus test at the heart of Boris Johnson’s mass-testing strategy missed more than 50% of positive cases in an Operation Moonshot pilot in Greater Manchester, the Guardian can reveal.

The 20-minute tests, on which the government has spent £323m for use on hospital and care home staff with no symptoms, identified only 46.7% of infections during a crucial trial in Manchester and Salford last month.

This means that many of those carrying Covid-19 were wrongly told they were free of the virus, potentially allowing them to infect others.

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The test is one of those due to be used in the UK’s first city-wide mass-testing initiative which starts in Liverpool on Friday. It has also been rolled out to a number of other hospitals in England.

Scientists with Greater Manchester’s mass testing expert group (MTEG) raised significant concerns about the accuracy of the OptiGene Direct RT-Lamp tests this week, and said the technology should not be widely used as intended in hospitals or care homes.

The findings pose significant questions about one of the main tests in the government’s mass-screening strategy, which Johnson heralded this week as the UK’s main route back to normality. The prime minister told MPs on Monday that the government was “rolling out testing of all NHS staff as fast as we possibly can” and that it wanted to introduce rapid, regular testing for hospitals, care homes, schools and universities.

The Salford trial was billed as the first step in the Operation Moonshot mass-testing scheme but was drastically scaled back after just six weeks, in part due to concerns about the accuracy of the OptiGene test, the Guardian understands.

Local leaders had asked the government for clinical validity data behind the technology, but it is understood this data has not been provided.

The MTEG, which reports to the region’s health chiefs and the Greater Manchester mayor, Andy Burnham, revealed their concerns about the Operation Moonshot findings to Martyn Pritchard, the chair of the city region’s testing strategy group on Monday.

In a letter seen by the Guardian, they wrote: “The current available data from the Manchester Pilot shows low sensitivity (46.7%) of the Direct RT-Lamp platform,” which is favoured for use in hospitals because of its ability to produce results in around 20 minutes.

They wrote that “a high proportion of samples collected from infected individuals in a ‘real world’ setting would not be detected” using the technology and added: “MTEG has significant concerns and do not feel the data supported the investment in the large scale roll-out of Direct RT-Lamp saliva testing in any of the proposed clinical settings considered (hospital staff, care staff, community settings) at this time.”

The Greater Manchester experts conclude that “technical limitations of the system were also a cause for concern”, including the lack of internal controls, and that if not addressed “these may pose a significant risk of errors”. They added: “It should be noted that solutions to these issues are not available at this time and are likely to take considerable resource and time to address.

“It is also of concern that the scale of investment needed [at a ‘new department’ level] to deploy this test at a scale that would be useful and sustainable is unlikely to be cost-effective.