Problem with Primerdesign rapid covid testing machines29 Nov 2020 11:15
Further rollout 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 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 hospitals 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 being forced to consider its contract with Primerdesign after NHS officials and biomedical scientists flagged concerns over the machines - 160 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 likely 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 Soci
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