Senior scientists believe that health officials should have been notified within days of major problems at a private Covid testing laboratory, and not wait for weeks to fix the issue.
Around 43,000 people, mostly from south-west England were wrongly told by Immensa Health Clinics laboratory at Wolverhampton that they didn't have the virus in an incident described as the worst scandal in the UKs Covid crisis.
The affected swabs were taken from September 2nd, but Immensas quality control process and oversight by the UK Health Security Agency (UKHSA), did not raise the alarm. Concerned members of the public raised concerns, prompting a formal investigation.
This is a very high ranking Covid scandal in the long list of Covid disasters.
Anecdotal reports should not be relied upon to identify a problem this large. He added that this is the most unforgiveable aspect of this. It is not unreasonable to suggest that a total failure in quality in the lab could lead to serious illnesses, possibly hospitalisations, or worse.
After academics raised concerns about discrepancies between regional Covid test data, the UKHSA suspended Immensa's work on 12 October. It was at least three weeks later that it resumed.
This failure has led to calls for the government publishing its contract with Immensa and transferring as much testing to the NHS and university labs. Additionally, the government should establish stricter oversight of the hundreds private companies that have rushed to enter the Covid testing market, often without any track record in delivering clinically critical tests.
One UK researcher, who is not authorized to speak on the subject of Covid testing, stated that the problems at Immensa were almost predictable due to the manner in which private companies were brought into testing.
The commercial potential grew quickly because it was allowed and encouraged to do so, with very little oversight. This technology is now so common that anyone with laboratory experience can use it.
It is not surprising that there are companies that have been set up to do potentially unreliable testing. This is because you created the market opportunity.
Tests that were to have been sent to Immensas Wolverhampton laboratory are now being diverted to other businesses. Individuals who have received false negative results have been advised not to take another test.
The sensitive PCR tests that are used to analyse Covid swabs include built-in controls which should immediately flag any failed tests to the operator. Computer software interprets PCR machine results, but good laboratories will check for unusual patterns like prolonged periods of no positives.
McNally stated that if it wasn't picked up internally, the only conclusion I can draw from having overseen over a million and fifty of these tests is that no one was reviewing the data coming out of the PCR machine.
Deenan Pillay is a Professor of Virolology at University College London and a Member of the Independent Sage Group. He stated that the Department of Health and Social Care must publish its contract to Immensa in order for quality control measures contained within the document to be scrutinised.
He suggested that as much private testing as possible be transferred to the NHS and university laboratories, where quality control and lab heads are responsible for test reliability.
He said that it was surprising that such a problem wasn't detected in the laboratory on the same day. Anything that looks unusual, even if there are fewer positive tests, is a red flag.
Labs are prone to errors. To quickly identify problems, you need a variety of systems.
A spokesperson for DHSC claimed that the Immensa laboratory was fully accredited by Ukas, the UK's independent accreditation service. However, Ukas quickly clarified that it had not accredited Immensa or its sister company Dante Labs.
The UKHSA stated that the problem had not started on September 8th, as it was incorrectly stated, and that it actually began six days earlier.
False negative results can have serious consequences. According to a Covid testing researcher, false negative results can make you a danger to yourself and others. Although I am sure there would be obstacles to increasing NHS capacity, I believe that it was the right decision. It would have greatly prevented what we had which has been a free-for-all with an apparent knock-on effect to quality.
If the clinical tests aren't robust and aren't properly controlled, what is the point? What are we trying to say if this doesn't make a good stink? It's okay to run tests that don't make sense.
McNally suggested that PCR testing may be dropped in the UK because of high numbers of cases. Why would you continue to spend so much taxpayer money on PCR testing for an infection the government has no control over? It makes zero sense, he said. The enormous testing budget can be used for something that could make a difference such as helping people who are isolated.
Dr Will Welfare, incident director for Covid-19 at UKHSA said that the investigation into Immensa is ongoing. There is no evidence that PCR test kits or lateral flow devices are defective. The public should continue to use them as well as other services provided by the UKHSA.