The continued deployment of a rapid coronavirus testing machine in English hospitals is set to be halted due to difficulties in operating the technology, leaving the government with a big void to fill as it strives to restore services of the NHS at full capacity.
As part of Operation Moonshot, Downing Street ordered 300 high-tech PCR testing devices designed by Primerdesign, a Southampton-based diagnostic company, to be placed in clinical settings across the country.
High hopes were initially raised on the machines which, when delivered and installed, could have processed around 60,000 samples per day.
This would have allowed patients and hospital staff to be promptly assessed before surgery or other procedures – a critical condition for getting health services back on track.
however, The independent understands that the government is currently reassessing the testing platform after NHS officials and biomedical scientists raised concerns over the machines – 200 of which have so far been delivered to hospitals.
During the first deployment of the devices, hospitals in a range of trusts, including Norfolk Community Health and Care NHS Trust, warned that they did not have the ancillary products or staff needed to operate the machines.
The Primerdesign device requires a “multi-pipette” distillation process that sees the patient’s swab samples placed from one solution to another by trained biomedical scientists, before finally being processed through the machine.
Hospital figures have argued that the procedure, which also requires large protective cabinets to prevent sample exposure and contamination, is too complex and time consuming.
Originally sold as a point-of-service device that would allow rapid on-site testing, the complexities and equipment involved in operating the machines “essentially turned it into another lab test,” a source said. close to the deployment of Primerdesign. The independent.
The sensitivity results produced by the hospital’s own verification tests are also believed to be lower than those initially described by Primerdesign – a result likely influenced by the difficult multi-pipette distillation process.
This has cast doubt on whether the platform is accurate enough to be used for testing patients in emergency departments, raising concerns that the machines could return false negatives and positives.
The devices are also being assessed by the government technical validation group, which includes viral testing and infectious disease experts from Public Health England and the UK Medicines and Health Products Regulatory Agency.
Given the expected initial production of the Primerdesign machines, the question of how the Department of Health and Welfare will fill the void left by their planned withdrawal remains unanswered.
A second deployment of the devices, which would have made it possible to install the remaining 100 kits in English hospitals, is currently under consideration.
Justin Madders, Labor’s shadow health minister, said the revelations were “incredibly concerning” and “raise serious questions about the government’s winter plan and its impact on NHS staff and patients.
“It seems once again that the big announcements and strategies are based on untested technology that doesn’t always work in the field,” he said. The independent. “Ministers urgently need to define their contingency plan.”
Munira Wilson, MP for Twickenham and Liberal Democrat spokesperson for health and welfare, said The independent: “Unfortunately, once again, we see a contract distributed by this government fail. It’s only fair that the contract be revised so that the public doesn’t end up footing the bill for a test kit that just doesn’t perform as promised.
“Likewise, we need to hear directly from ministers on the steps they have taken to compensate for any insufficient testing resulting from this latest issue. ”
The government has insisted the deployment is not interrupted and there are no plans to remove existing machines, some of which have been validated and are now providing rapid tests to patients and hospital staff.
A government spokesperson said: ‘All of the testing technologies used in NHS hospitals have been clinically validated and are very accurate.
“New testing technologies are being developed at a steady pace to enable rapid and accurate diagnosis of Covid-19, and ongoing assessment of these technologies is underway as they are deployed across the NHS.
“We will continue to analyze and determine the best clinical use for all of our rapid technologies, including Primerdesign, and will deploy these tests across the NHS in accordance with the latest findings.”
Primerdesign declined to comment.
Along with the Primerdesign machines, the government also provided hospitals with rapid test “boxes” made by DnaNudge, a London-based healthcare company.
In August, Downing Street announced that 5,000 of these machines would be able to deliver 5.8 million clinical tests during the winter period.
Primerdesign, a subsidiary of the Anglo-French biotechnology group Novacyt Group, was the first European manufacturer of medical devices to launch a test for the detection of Covid-19.