The Innova tests: another Covid scandal in the making? Part 2 [10/06/21]

This is the second instalment of my three-part investigative report for TCW on the Chinese-made Innova lateral flow test. On Monday I examined the background to the Government decision to commit vast sums of UK taxpayers’ money to a California start-up for tests that, like the PCR test, manifested significant problems from the start.

A JOINT report by Public Health England (PHE) Porton Down and Oxford University published early last November gave the Government the green light to invest in and roll out the new lateral flow test (LFT). The ‘newly deployed lateral flow tests are highly reliable, sensitive and accurate in multiple settings’ and ‘sensitive enough to be used in the community, including for asymptomatic people’, they announced, singling out the Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test, selected for a Liverpool pilot scheme starting that same week. This, they explained, was because only Innova’s LFT was reported to be nearing completion of the 4-stage process at the time. 

Led by an oversight group chaired by Sir John Bell, Regius Professor of Medicine at Oxford University, the evaluation programme had begun a few months earlier in August. Of the 120-plus LFTs submitted for this review, 40 passed phase 2 validation, 24 passed phase 3a validation and just four tests showed a sensitivity rate (the proportion of people who have the disease and get a positive result) of more than 70 per cent. The report focused on just one of these, Innova, and listed its attributes: a test specificity recorded as 99.68 per cent; an overall false positive rate of 0.32 per cent, and an overall sensitivity of 76.8 per cent for all PCR-positive individuals – ‘over 95 per cent of individuals with high viral loads’ – and showing a ‘minimal difference between the ability of the test to pick up viral antigens in symptomatic and asymptomatic individuals’. 

These high sensitivity rates were recorded when the test was conducted by laboratory scientists. However, when used by trained members of the public, the rate dropped to 57.5 per cent. Surprisingly, this was not flagged as a problem by either Sir John Bell, who oversaw the report, or Susan Hopkins from PHE. Both concluded that the Innova test had ‘sufficient sensitivity’. 

Within days of the publication of the evaluation, other experts warned in the BMJ that, to the contrary, the Innova lateral flow test was not fit for this ‘test and release’ strategy as the tests ‘may miss as many as half of Covid-19 cases, depending on who is using them’.

Jon Deeks, professor of biostatistics at the University of Birmingham and leader of the Cochrane Collaboration’s Covid-19 test evaluation activities, could not have made his criticism clearer: ‘Independent evaluations for the World Health Organisation have shown that other lateral flow antigen tests are likely to outperform Innova, but even those do not have high enough sensitivity to rule out Covid-19. The Innova test is certainly not fit for use for this purpose.’ 

Another damning article in the BMJ a few weeks later claimed the Innova lateral flow tests were ‘highly inaccurate’. It reported ‘early results [of pilot studies] from students testing at the University of Birmingham and universities in Scotland showed that tests had a sensitivity of just 3 per cent and that 58 per cent of positive test results were false.’  

Their warnings might have proved a new blow to the UK government’s ambitious plans for mass testing, but they were ignored. No brakes were applied. The use of the Innova Lateral Flow Test for the NHS Test and Trace scheme, to be rolled out to universities, hospitals, care homes and all secondary schools, was planned regardless.

Impervious to the critiques, a later PHE and Oxford University performance evaluation of the Innova LFT against the PCR test (co-authored by Susan Hopkins and published in March 2021) found: ‘In phase 2 and 3a, where the same sample was used for both PCR and LFD specificity analyses, no false positives were detected.’

Such confidence as to the efficacy of the Innova tests curiously predates as well as postdates their UK clinical evaluation, and by some months. Examination of the government’s purchase contracts for tests from IMG (Innova Medical Group) shows their first contract was agreed as early as September 2020 for £103.6million. Subsequent contracts with IMG made before Christmas, before and after PHE and University of Oxford published the results of their evaluation, totalled just under one billion pounds. 

Here is their time line  government’s contracts with Innova Medical Group.

Professor Tim Peto of Oxford University, chief investigator for lateral flow tests (overseen by Sir John Bell), admitted, ‘We had to buy before we knew they worked’ arguing that ‘there was huge worldwide demand’. Officially the justification for using Innova as the sole supplier without a call for competition was that it was in accordance with Article 32 of the contract conditions: 

‘Innova are the only available supplier of home use lateral flow tests for Covid-19 as there is currently no other supplier whose Covid-19 tests are authorised by the relevant regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), for self-test use in the UK . . . No reasonable alternative or substitute exists: there is currently no other supplier of lateral flow devices that has MHRA authorisation for the self-test use needed to satisfy DHSC’s (Department of Health) requirement.’ 

But why so many pre-orders for such huge numbers and amounts of money given the uncertainty surrounding them? The DHSC justification looked increasingly tenuous from January onwards when the Liverpool School of Tropical Medicine announced that the Excalibur Rapid SARS-CoV-2 Antigen Screening test, validated by LSTM, had been granted MHRA approval, stating: 

‘Now, following approval from the Medicines & Healthcare Products Regulatory Agency (MHRA), the Excalibur Rapid SARS CoV-2 Antigen Screening test can be deployed for widespread mass screening of populations to rapidly track down infectious individuals capable of spreading the disease.’ (My italics).

It’s striking that after January, further huge contracts were granted by the Government to Innova alone.

The largest of these, for £1.2billion, was agreed after Excalibur’s MHRA approval; it stated a contract delivery date of 13 March to 28 April, and used the same legal justification for use of Article 32.

How was it that the UK-based firm Excalibur Health Care Services, led by Professor Sir Christopher Evans, a leading biosciences, medical and healthcare entrepreneur, was overlooked by the UK government in favour of Innova, an obscure US start-up?

Nevertheless, armed with the Innova kit, the mass testing rollout planned by the government to coincide with the return to school and college on March 8 this year, went ahead. Secondary school and college students were to take an initial three tests at school and then twice weekly at home, all to be administered by themselves, not by trained professionals.

Further plans for expanding community testing were announced in April in which everyone was to be given access to two free tests a week. 

Today, the Government’s contracts with the mysterious Innova Medical Group total £3.2billion, an astonishing sum to go to one single start-up company based in California for a test that has proved to be unreliable, on the basis only that it would quickly be able to supply the vast quantities of the test the Government assumed it needed. Daniel Elliott, IMG’s chief executive, explained: ‘There was a lot of discussion of course about the technology, but it also came down to our ability to supply. Nobody else was anywhere near our production capacity.’

Read More – The Innova tests: another Covid scandal in the making? Part 2