The market for new coronavirus tests is a 'Wild West' and better regulation is needed to adequately protect the public, a leading expert has said.
Professor Jon Deeks, who leads the evaluation of coronavirus tests for the Cochrane collaboration - an independent network of medical researchers - told The Telegraph that the current system is not fit for purpose.
Moreover, he said, the situation is only getting more serious as the government pushes for more testing and new types of test, under its "Operation Moonshot" plan.
Professor Deeks said: "We have changed the laws for drugs over the years - usually at the point when they have killed people by accident and when we realise that the legislation is not protecting the public. I think this is what we need to be doing right now for tests."
While drugs have to go through extensive testing, licensing and evidence reviews, medical tests are regulated differently. They have to comply with the European Union's minimum safety and performance requirements, and then the manufacturer can put a 'CE' mark on the product, and put it out on the market.
As such, many tests do not have any independent assessment of their performance before use, Professor Deeks, a bio-statistician at the University of Birmingham, said.
That is the case for a number of the tests mooted by the government as key for ramping up testing as Britain faces a second wave of the virus - many of which are still in development.
"We've got a 'Wild West' type of approach to things at the moment," said Professor Deeks. "The government is trying to make us hope that things will get better, so they are pushing out stories about new testing technology which are optimistic and not always accurate. At the same time, some companies are doing the same thing."
While the tests themselves are not dangerous, rolling out new tests without proper scientific scrutiny could lead to huge problems, Professor Deeks said.
"If you tell people they haven't got Covid when they have, they won't isolate and will potentially infect lots of people. And if you tell them they have [Covid-19] when they haven't, they will self-isolate. Individually that's probably not such a bad thing, but if you tell lots of people wrongly to isolate, you end up with substantial economic harm," he said.
At the moment, the main coronavirus test in Britain is a PCR swab test, used to detect if someone currently has the virus. Once a sample is taken from the back of the throat and inside the nose, it is sent off to a laboratory for processing.
While the tests are reliable, recent gridlocks have caused huge delays in the system.
"We need to do better than we are doing now," said Prof Deeks. "Any improvement is worth seeking."
The new types of tests being trialled variously promise to give results more quickly, to test samples on-site, or to use saliva as a sample to detect the virus.
But their claims are not always backed up by data, said Professor Deeks. For example, he said he had seen no published data at all on the LamPORE test that made headlines at the beginning of August, which government documents suggest will be part of 'Moonshot'. He said it was clear from the laboratory process that the swab to result time was many hours, though, and not 90 minutes as has been suggested. A research paper on these tests is thought to be imminent.
The newly announced iAbra Virolens tests - trialled at Heathrow Airport and apparently capable of delivering a result from saliva in 20 seconds - were also not supported by any published evidence, Professor Deeks said, and the company's information pack did not include key data backing up their performance claims.
A spokesman for the test's manufacturer told The Telegraph the team had "significant expertise" and were focused on developing a machine capable of delivering the technology at scale.
"It has the potential to make a significant difference to Covid testing, but it is currently embarking on functional and clinical trials and it wouldn’t be appropriate to comment further until the results of those are known," a spokeman for the test developer added. "We are poised to roll-out once we receive the requisite approval.”
The DNANudge portable testing units which give results in 90 minutes and are now being used in a number of NHS trusts, do have a good study behind them showing their reliability and accuracy, Professor Deeks said. But while the testing kits are portable, they have limited capacity. The study also showed that their accuracy was good, but that 1 in every 10 tests had to be re-done.
Prof Deeks said they all could have a role to play in various different testing scenarios, from doctors' surgeries to care homes, but stressed that more evaluation was needed, and more consideration of which tests were best for which settings.
However, he cautioned against holding out hope for a simple saliva test, saying the evidence so far suggested reliable tests of this type are unlikely to be available widely in the next few months.
He also said that more work needed to be done on measuring infectiousness - something the existing tests, which only detect the presence of the virus, do not show.
He said the critical thing to do now, rather than relying on new technology, is to improve the existing system, using resources that are already available.
"We have public health teams all over the country, and they know what they are doing," he said.
"There's the NHS transport system for transporting samples between GPs and labs, for example. This all exists, and if we want it quickly - and we need it right now, this week - why on earth are you not using your National Health Service?"
Similarly, he said the government could make more use of the Condor evaluation programme (Covid-19 National Diagnostic Research and Evaluation Platform), funded by the National Institute for Health Research, among others, to independently assess new tests.
"If you are testing any drug, the trial has to be publicly registered, the protocols available, the results published on the trial register, and we must do the same for tests," he said.
"Companies need to be more transparent so we can trust how well things work, stop the virus, and save lives."
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