Further rollout of a rapid coronavirus testing machine in English hospitals is set to be paused due to difficulties in operating the technology, leaving the government with a large gap to fill as it works to restore NHS services to full capacity.
As part of Operation Moonshot, Downing Street ordered 300 high-tech PCR testing devices designed by Primerdesign, a Southampton-based diagnostic firm, which were due to be placed in clinical settings across the country.
High hopes were initially raised over the machines, which – once delivered and installed – would have been able to process roughly 60,000 samples a day.
This would have allowed hospital patients and staff to be quickly assessed prior to surgery or other procedures – a key requirement for getting health services back up and running.
However, The Independent understands that the government is now reassessing the testing platform after NHS officials and biomedical scientists flagged concerns over the machines – 200 of which have so far been delivered to hospitals.
During the first rollout of the devices, hospitals from a range of trusts, including Norfolk Community Health and Care NHS Trust, warned that they did not have the necessary ancillary products or staff needed to operate the machines.
The Primerdesign device requires a “multi-pipette” distillation process that sees patient swab samples placed from one solution to another by trained biomedical scientists, before eventually being processed via the machine.
Hospital figures have argued that the procedure, which also requires large protective safety cabinets to prevent exposure and contamination of samples, is too complex and time-demanding.
Originally sold as a point-of-care device that would enable rapid testing on the spot, the complexities and equipment involved in running the machines have “essentially turned it into another lab-based test”, one source close to the Primerdesign rollout told The Independent.
Sensitivity results produced by the hospital’s own verification tests are also thought to be lower than originally outlined by Primerdesign – an outcome probably influenced by the difficult multi-pipette distillation process.
This has called into doubt whether the platform is accurate enough to be used to test patients in emergency departments, raising concern that the machines may return false negatives and positives.
The devices are also evaluated by the government’s Technical Validation Group, which includes experts in viral testing and infectious disease from Public Health England and the UK’s Medicines and Healthcare products Regulatory Agency.
Given the initial expected output of the Primerdesign machines, the question of how the Department of Health and Social Care will plug the gap left by their anticipated removal remains unanswered.
A second rollout of the devices, which would have seen the remaining 100 kits installed in English hospitals, is now under review.
Justin Madders, Labour’s shadow health minister, said the revelations were “incredibly concerning” and “raise serious questions about the government’s winter plan and the impact on NHS staff and patients.
“It does seem once again that big announcements and strategies are based on untested technology that doesn’t always deliver on the ground,” he told The Independent. “Ministers need to urgently set out what their contingency plan is.”
Munira Wilson, MP for Twickenham and the health and social care spokesperson for the Liberal Democrats, told The Independent: “Sadly yet again we are seeing a contract dished out by this government failing to deliver. It is absolutely right that the contract is reviewed, so that the public does not end up footing the bill for testing kit that simply isn’t functioning as promised.
“Equally, we need to hear directly from ministers about the steps they have taken to make up for any shortfall in testing resulting from this latest glitch.”
The government has insisted that the rollout is not being stopped and that there are no plans to remove the existing machines, some of which have been validated and are now providing rapid testing for hospital patients and staff.
A spokesperson for the government said: “All the testing technologies used in NHS hospitals have been clinically validated and are highly accurate.
“New testing technologies are being developed at pace to enable speedy and accurate diagnosis of Covid-19, and ongoing assessment of these technologies is taking place as they are rolled out across the NHS.
“We will continue to analyse and determine the best clinical use for all of our rapid technologies, including Primerdesign, and will deploy these tests across the NHS in line with the latest findings.”
Primerdesign declined to comment.
Alongside the Primerdesign machines, the government has also been delivering rapid testing “boxes” manufactured by DnaNudge, a London-based health firm, to hospitals.
In August, Downing Street announced that 5,000 of the machines will be able to provide 5.8 million tests in clinical settings over the winter period.
Primerdesign, a subsidiary of Anglo-French biotechnology group Novacyt Group, was the first European medical device manufacturer to launch a detection test for Covid-19.
The headline of this story was changed on 2 December, 2020. It previously said: “Coronavirus: Rollout of rapid testing machine in English hospitals to be halted due to operating issues”