In autumn 2020, the Cardiff University in UK began testing its employees and students for the coronavirus before re-opening the campus. The tests began on 5 October 2020 and used a rather unconventional method of nucleic acid extraction from saliva. According to the man appointed as service manager, Neil Evans, the unorthodox method was not validated before the launch, which the university however unconvincingly denies. On top of everything, the nucleic acid extraction beads were purchased by the university without any tender, from a newly registered company belonging to one of its scientists, the same one who was validating the testing service.
Evans was appointed as “Covid-19 Testing Service Manager” by the Cardiff University, but quit his post very soon in disappointment. Part of the affair, with the statements of Evans and rebuttals by the Cardiff University, was already covered by the BBC and Wales Online. Regarding the usefulness of saliva-based assays, BBC quoted an expert, Allan Wilson, president of the Institute of Biomedical Science:
“My primary concern is the use of saliva as a sample for a PCR. This is unusual practice within the UK and as far as I’m aware is not used in any other diagnostic laboratory setting.“
The unconventional source of the PCR template was the bulk nucleic acid extracted from saliva, containing both person’s DNA and RNA, including any potential viral RNA from the coronavirus. Such novel approach certainly needs validation to prevent false positives, and in particular false negative results: for example where the method erroneously detects genomic DNA as housekeeping gene and reports the test as successful all the while the extraction soup may been devoid of any RNA, viral or otherwise. The university claimed in the media and to me to have sent all positively-tested students to undergo an additional verification via a standard nasal swab test with the UK public health provider, the NHS:
“As we only offer to test individuals who have no symptoms, any cases of infection we identify and who are subsequently confirmed by an NHS test are, by definition, an asymptomatic case identified. Cardiff University case numbers are reported here: https://www.cardiff.ac.uk/coronavirus/covid-19-case-numbers “
But what about those potentially virus-carrying students who tested negative because of an unvalidated test? Cardiff University chose not to talk about that, they did tell the BBC that
“On the validation process, it said it has not requested negative samples externally analysed by PHW [Public Health Wales] “as we are mindful of the pressures on their services“.
We do know that the urged campus reopening last autumn proved a disaster throughout UK. Was the Cardiff test ever sufficiently validated, and if yes, by whom? It seems both points were problematic.
Wales Online quoted Wilson with:
“”One concern was there was no evidence of how they validated the test when they introduced it, by that I mean an internal validation.” He explained that normally in a lab when a new test is introduced a known set of tests already validated from another lab, so confirmed negative results, for example, would be run to confirm outcomes from that record to compare. Ongoing interim tests would also normally be carried out, he added.“
The roll-out of the tests was announced by a university press release on 23 September 2020, the day Evans threw in the towel and resigned in frustration, with the first tests nevertheless scheduled already for “at the end of the month“.
I was forwarded an email exchange between Evans, his colleague Tomasz Jurkowski, and Andrew Westwell, Dean of Research and Innovation in the College of Biomedical and Life Sciences in Cardiff and the man in charge of supervising the coronavirus testing platform. The people involved and the Cardiff University were asked to comment on these emails, they voiced no objections to their authenticity.
It was Jurkowski’s magnetic beads the system used, which are described on the “community platform” Bomb.bio he runs some colleagues. It seems, Evans was initially under the erroneous impression Jurkowski donated his proprietary beads to Cardiff University’s testing system.
On 18 September, Evans wrote this email to Jurkowski
“We have to run a validation of the multiplex and we also have to run a validation of the three different magnetic beads, for Tuesday we have no choice to use your Bomb.Bio ones.
In a nutshell I joined the team too late to get everything in place, I was led to believe all manner of validations had occurred on the light cycler in your laboratory.“
Evans also complained that Jurkowski had his own PhD student run the tests and not the laboratory manager employed by the department for exactly that. Two days later, on 20 September, Evans sent a long email where he wrote:
“Upon taking up my position of Service Manager I was led to believe that we would be using an “in-house” designed total nucleic acid extraction process. I had a few reservations around this such as GMP and GLP compliance, CE marking, patent infringement and reliability […] Personally, I would have preferred to be
working with purified RNA rather than total nucleic acid but I was happy to continue for the above reason of novel innovation.
However, it was brought to light, at least for me personally, last week that in actual fact the magnetic beads that I assumed were owned by Cardiff University from some novel innovation created during lockdown are actually owned by a private company and are going to cost thousands of pounds to purchase. […] This is even more pressing as the company that owns the beads is owned by Tomasz Jurkowski. Tomasz has now accepted that we need to validate his beads alongside two other manufacturers. Alternative beads have been ordered by Tomasz, he may feel he was helping, but this all has to happen without his involvement.“
Indeed, the beads were purchased and not donated. Purchased outside of all tender, meaning without any competition from other manufacturers. A very strange approach when designing an already unorthodox SARS-CoV2 testing system based on whole nucleic acid extraction from saliva. The Cardiff University explained to me:
“Bomb.bio (https://bomb.bio/about/) is an Open-Source magnetic isolation platform, not a company.
A consumable component, magnetic beads, used by the laboratory was supplied by Magnacell Ltd, a company that has Dr T Jurkowski as a director. Cardiff University did not tender for these consumables at the time to avoid competing with NHS supply lines and is now in the process of initiating its tender processes for additional stock.”
Indeed, Magnacell was incorporated by Jurkowski as its only officer on 23 July 2020 (see records here). The registered office address of MagnaCell is a dud one: “71-75 Shelton Street, Covent Garden, London, WC2H 9JQ”, which is a postbox service openly offered on sale for foreign and domestic business people at a price of GBP 39 plus VAT. Jurkowski also uses it as his own correspondence address.
Draw your own conclusions what Cardiff University did there. Also, according to Evans, another Welsh university trialled those same MagnaCell beads for a sewage detection of the SARS-CoV2 virus. Somehow, the Bangor University then went for the same product which NHS is using, and no competition issues there.
Evans also criticised further details of the testing setup, namely the choice of the reagents and primers for the quantitative Real-Time PCR (qRT-PCR) test needed to amplify and detect the viral genome and the lack of validations for these. He then announced to “terminate my secondment with immediate effect.“
On 21 September, Westwell replied to Evans regarding the nucleic acid extraction beads:
“It is certainly true that the BOMB nucleic acid extraction protocol, and the opportunity to scale this extraction platform, sits at the heart of our service. Tomasz was instrumental in establishing the protocols in Cardiff, using the technology he had helped to develop in Germany. One of our motivating factors here was the need to set up a service that was non-competitive with the NHS for key reagents/equipment.[…] we will be running comparative studies to provide
reassurance around comparative bead performance.“
Evans replied the next day with another lengthy email, requesting urgently, among other things, “Documented evidence that the magnetic beads supplied by Bomb.Bio/Tomasz can recover Sars-Cov2 from samples. Ideally saliva but any medium will do“. He also reminded everyone that even “at Bomb.Bio website they state that they are currently validating their beads for SARS-COV2 and hope to have information soon“. And yet the Cardiff University was ready to test all its students for campus readmission literally in the next days.
Evans also reiterated that the qRT-PCR machines were not calibrated, likening it to “weighing out drugs to be administered on an uncalibrated balance“. He also again insisted for Jurkowski to “distance himself and assume a consultancy role this was to protect him from the conflict of interest he faces regarding Bomb.Bio involvement“.
Westwell replied on 23 September, without bothering fulfilling Evans specific requests, to which Evans immediately reacted with an email of protest and final resignation. This was Westwell’s non-negotiable position:
“We have had to move at pace to establish a workable end-to-end system with the imminent arrival of students and staff back to campus for the teaching year.
Workable, not necessarily fully optimised, but these are extraordinary times. […]
What you are asking for is simply not deliverable within our current resource and timeframe ahead of the new academic year, noting that multiplexing and
comparative bead extraction studies are on our near-term agenda.”
Thing is, Cardiff University claimed to me something else:
“A comprehensive evaluation of magnetic isolation beads from different suppliers was undertaken as part of the laboratory quality control protocols and demonstrated the favourable performance of the Magnacell beads against other, similar products. The internal evaluation of the beads was done independently of Dr Jurkowski and the tests evaluated performance of the beads for SARS-CoV-2 RNA extraction using both synthetic controls and heat-inactivated virus. The systems employed for RNA extraction are designed to be compatible with a range of magnetic beads and extraction kits available on the market. “
This statement makes little sense. On 23 September, Westwell admitted to a lack of optimisation and to utter lack of comparative tests, while rejecting Evan’s request to have someone else but Jurkowski or his PhD students run such validation studies. It takes 48 hours to produce the results from a saliva sample, the Evans emails and even the university press release state this. And how about ordering reagents, having them delivered, validating the reagents, setting up the equipment, and comparing the results?
It is utterly impossible for the Cardiff University to have done all that in the 7 work days between the email and the begin of the mass-tests on 5 October, unless they own a time machine. If anything they might have done some validation and comparison tests afterwards, after the entire campus has been screened. What would be the point in that, is another issue. I pointed out this inconsistency to the university, but have received no reply yet.
By the way, the Cardiff coronavirus testing facility is located in the Martin Evans Building, named so after the university’s former Vice-Chancellor Sir Martin Evans (no relation to Neil Evans), the Cardiff entrepreneur whose company Celixir peddles mysterious cell therapies for heart injections, based on a patent with stolen data and an unethical clinical trial in Greece which was sanctioned by the authorities. Evans’ attempt to run a phase 2b clinical trial on 50 UK patients at the Royal Brompton hospital in London eventually went tits up, even his Nobel Prize gravitas was no match against the investigative work by the Liverpool professor Patricia Murray. You can read more about this bizarre affair on my site (here, or most recently, here), or even in the British national media, in particular in Private Eye.
That same Cardiff University is so business-minded that it previously whitewashed a rather dishonest peddler of Photoshopped science. Likely because their oncology professor Wen Jiang brings to his university some serious investment money from the Traditional Chinese Medicine (TCM) industry. I was accused of slandering Jiang and TCM in a press release, my freedom of information request for the investigate report was rejected.
Never mind, it’s not about the quality of the science, it’s about the money one can make with it. Jurkowski, whose proprietary product solved the COVID-19 testing problem literally unchallenged, now got a governmental grant to develop his “Novel technologies for point-of-care genetic testing for SARS-CoV-2”. Jurkowski never replied to my emails and his university instructed me not to contact him anymore.
If you are interested to support my work, you can leave here a small tip of $5. Or several of small tips, just increase the amount as you like (2x=€10; 5x=€25). Your generous patronage of my journalism will be most appreciated!