Coronavirus UK: Rapid test trials miss over 50% of positive cases 

Operation Moonshot was dealt a damaging blow on day one in Liverpool as one of the rapid coronavirus tests set to be used in a mass-testing scheme was found to be less than 50 per cent accurate in a trial. 

Officials have now cancelled plans to include Optigene Direct RT-Lamp tests, bought because they give swab results in just 20 minutes, in their city-wide trial.

Catastrophically, the tests have missed more than 50 per cent of positive cases in a trial in Manchester, meaning they risk dangerously undermining the number of people who are actually infected.

Trials in Salford were scaled back after just six weeks, in part due to concerns about the accuracy of the OptiGene Lamp test, according to The Guardian.

Scientists on Greater Manchester’s Mass Testing Expert Group reported a positive-detecting accuracy of just 46.7 per cent and found that ‘a high proportion of samples collected from infected individuals in a “real world” setting would not be detected’. 

The Department of Health has dismissed the group’s finding and said four other real-world trials and further lab tests had put the accuracy between 80 and 96 per cent. 

But Liverpool City Council has now said it will not use the tests which, it had been hoped, would form part of the city’s pilot of whole-city testing which starts today.

All of the city’s 500,000 residents are being encouraged to get swab-tested for Covid-19 during the lockdown as walk-in test sites are springing up across the city. It is the first time the Government has opened testing up to members of the public who don’t have symptoms of disease.

The mass testing will still go ahead and all residents are able to book tests from this morning. Standard swab tests will be used as well as other types of on-the-spot tests. 

Liverpool today becomes the first city in England to open up coronavirus testing to all of its residents, regardless of whether they have symptoms or not (Pictured: A testing centre at Stanley Park near Anfield)

OptiGene Direct RT-Lamp test mixture

The Optigene Genie HT, which processes swab tests and can return results in 20 minutess

The OptiGene Direct RT-Lamp test (pictured left, the test mixture and right, the Genie HT machine that processes the tests) has been dropped from a rapid testing trial in Liverpool after a study in Manchester found it was less than 50 per cent accurate

The number of people testing positive for coronavirus in Liverpool has plummted in recent weeks, from a peak of almost 3,500 per day in early October. The city remains one of the worst-hit parts of England

The number of people testing positive for coronavirus in Liverpool has plummted in recent weeks, from a peak of almost 3,500 per day in early October. The city remains one of the worst-hit parts of England

The findings of the Manchester trial raise major questions about one of the main tests in the Government’s mass-screening strategy, which Boris Johnson this week heralded as the UK’s main route back to normality.

The Department of Health has disputed the results, calling them ‘incorrect’ and maintaining that the test is good. 

But in a letter seen by the Guardian, scientists from the Manchester group (MTEG) said: ‘The current available data from the Manchester pilot shows low sensitivity (46.7 per cent) of the Direct RT-Lamp platform.’

According to the newspaper, the scientists said they had ‘significant concerns’ and felt the data did not support a large scale rollout of the tests to staff in clinical settings, such as hospitals and care homes.

Missing positive test results because of inaccurate equipment could lead to disaster in places with highly vulnerable patients and residents.

People who get false negatives – meaning they’re told they don’t have the virus when they actually do – may continue to live their lives as normal and spread the disease without knowing if they don’t get any symptoms.

A lack of symptoms, which is thought to occur more often than actually feeling ill with Covid-19, is the reason the Government wants to bring in mass testing.

Only by testing everyone, regardless of whether they’re ill or not, will officials ever understand the true size of Britain’s outbreak and get control of the virus.

The Department of Health has refuted claims that the test is inaccurate and said the trial in Manchester was one of five that have been done in separate laboratories, with the other three all backing up previous results suggesting a high level of sensitivity.

Professor Mark Wilcox, co-chair of the Department’s technical validation group, said: ‘The direct LAMP tests used in Manchester have been validated in other laboratories and in real-world testing for use in different settings.

‘It is incorrect to claim the tests have a low sensitivity, with a recent pilot showing overall technical sensitivity of nearly 80 per cent rising to over 96 per cent in individuals with a higher viral load, making it important for detecting individuals in the infectious stage. 

‘The challenge now is to understand the reasons for the difference in claimed sensitivity in one evaluation versus those in multiple others.’ 

The military have been drafted in to help with the mass testing scheme and three soldiers are pictured at Pontins holiday park at Ainsdale Beach in Southport

The military have been drafted in to help with the mass testing scheme and three soldiers are pictured at Pontins holiday park at Ainsdale Beach in Southport

A testing centre is pictured in Wavertree in Liverpool. The city's 500,000 residents will be able to get tested with rapid swab-testing machines as well as the usual PCR swab tests which take a few days to return results

A testing centre is pictured in Wavertree in Liverpool. The city’s 500,000 residents will be able to get tested with rapid swab-testing machines as well as the usual PCR swab tests which take a few days to return results

The Liverpool pilot is the first step towards successful mass testing, with sites being set up around the city and all of its residents encouraged to get tested in the coming days and weeks.

Hundreds of soldiers were this week deployed to the Pontins holiday park in nearby Southport in preparation for the scheme and six new test centres, set up in council-run fitness centres across the city, opened their doors at 9am today.  

WHAT IS THE OPTIGENE RT-LAMP TEST?

  • Sample type: Nasal & throat swab, or saliva
  • Turnaround time: 20 minutes
  • Tests per day: 300 per hour
  • Accuracy: Claimed 97% 
  • Price: Unknown

The OptiGene Direct RT-Lamp tests are nasal and throat swabs which can be processed using a portable machine that produces results within 20 minutes. 

Once swabs have been collected from patients, the samples are loaded into the devices, known as the Genie HT, which look for tiny traces of the virus in their DNA.  

The machines amplify the DNA billions of times chemically so they can detect the virus with extreme sensitivity. They can also be used with saliva samples.  

The test has been trialled by the Government on thousands of people in A&E departments, GP coronavirus testing hubs and care homes across Hampshire, Salford and Southampton. 

A trial of the tests at an NHS trust in Hampshire found the tests to be up to 97 per cent sensitive, meaning they should only miss three out of every 100 true positive cases, and 99 per cent specific, meaning only one in 100 people would get a false positive result. 

Department of Health officials said real-world trials estimate the sensitivity to be 97.32 per cent for swab tests and 82 per cent when used with saliva when used on people with symptoms. They said the accuracy is ‘comparable’ to the standard swab tests used by the Government.  

When used on random groups of people, whether they have symptoms or not, the overall sensitivity, the Department of Health said, was 79.74 per cent and up to 96.61 per cent in people with a large amount of the virus in their body.

Military and police vehicles were seen entering the park, usually a holiday destination for families visiting the seaside resort, through an entrance manned by Army personnel.

The Mayor of Liverpool, Joe Anderson said: ‘This is an incredible opportunity to turbocharge our efforts to reduce coronavirus in the city.

‘We are excited to be leading on this project, supported by the Department of Health and Social Care.

‘Let’s all get tested, for our families, our mates, our Liverpool and set an example to the country and the world.’

Everyone in the city is being asked to get tested, but particularly health and care workers, other emergency services and key workers and school or university staff and students.

Lateral flow tests, which work like pregnancy tests and give results in under an hour, will be used along with existing swab tests.

A Liverpool Council spokeswoman said more test centres will open in the coming days and that the pilot is expected to last for an initial 10 days, with a view to it being extended.

Tests can be booked online or on the NHS app and centres will accommodate walk-ins on the first day of the scheme, the spokeswoman said.

Testing will also take place using home kits and in hospitals, care homes, schools, universities and workplaces.

Director of Public Health for Liverpool Matt Ashton said: ‘The aim of this project is to quickly identify people who have the virus and reduce transmission substantially.

‘This exciting mass testing programme simply means asking everyone to volunteer to be tested, and for those who test positive to self-isolate straight away and prevent others from getting it.

‘This is a pilot scheme and we won’t get everything right, but it is a huge chance to drive down transmission rates and get life back to normal more quickly.’ 

On Thursday, Prime Minister Boris Johnson said that technical advances in testing, including a different type of rapid testing being piloted in Liverpool, could be a ‘real way forward through the crisis’. 

Mr Johnson told a Downing Street press conference: ‘These really are full of promise, I do think that testing does offer a real way forward for this country.’

He said mass rapid testing would allow a return towards normal life.

‘The advantage of this approach is that you can tell whether people are infectious or not immediately, within 10 to 15 minutes,’ he said.

‘Without having to worry about the time taken to get the answer from the current testing system, you can help those people to self-isolate if they test positive, and if they test negative, then of course, they’re free to do things with other people who test negative in something close to a normal way.’

However, some experts have urged caution, saying rapid tests are not as accurate as standard PCR swab tests processed in the lab and could result in people who are infectious being told they are not.  

MailOnline has approached OptiGene for comment.