ourNHS: Analysis

I raised an early alarm on PCR test scandal but authorities ignored me

Community volunteer demands inquiry into impact of mistakes by privately-run Immensa lab after huge spike in COVID cases

James Beecher
30 October 2021, 12.01am
Gloucestershire residents received false negative tests
Andrew Milligan/PA Wire/PA Images. All rights reserved

Nearly two months ago, the community coronavirus group that I help to run in Stroud started getting reports of locals receiving negative “confirmatory” PCR tests after they had tested positive with lateral flow tests. Despite often having multiple positive lateral flow tests, and symptoms, they were being told to go to school and work – and they were worried.

On 18 September, I circulated a weekly summary of local data (as I’ve been doing throughout the pandemic), and noticed a steep and sudden drop in the number of people testing positive throughout Gloucestershire. Nearly overnight, we had plummeted from slightly above the national average to apparently having the lowest rates in the country.

The situation was clearly weird. In my community report that day, I publicly questioned whether “a problem at a testing lab might be involved”.

By 30 September, I was concerned enough to contact the Department of Health and Social Care (DHSC) directly. They essentially ignored me for a fortnight, aside from an occasional, “Sorry, no answers yet” email when I chased them. Although I reached out to them as one of their identified ‘COVID community leaders’, they kept referring me to their media team, who promised to call but never did.

On 15 October, they sent me a press release announcing that they had suspended test processing at a private lab run by Immensa, and that 43,000 people, mostly in the south west, may have received false negative PCR test results, out of 400,000 tested by that lab since early September.

One of the affected locals who contacted me was Gayle Simpson – a severe asthmatic classed as clinically extremely vulnerable (CEV). She believes that she caught COVID from her school-age son.

She got tested at a drive-through site in Gloucestershire on 8 September, which came back negative. However, since she felt very ill and on the advice of her GP, she also went to hospital that day. The hospital test, processed at a different lab, came back positive. Within a few days, she was so ill that she was admitted to hospital and was kept in for four days.

Life-threatening repercussions

Simpson raised her concerns about the inconsistent test results with local health authorities on 10 September. She said: “I am recovering now but am still affected by breathing difficulties and fatigue. A thorough investigation needs to happen to find out exactly what caused all these errors. The repercussions of a false negative on a PCR could be life-threatening. I was lucky!”

Another Stroud resident, Mel Brown, told me:My husband was in hospital for two weeks – including two days in intensive care and a period in the high dependency unit – after our son was given what I believe was a false negative PCR. He is just back home but it is going to take him months to get fit physically and mentally.”

And another Stroud resident told me that her whole family received negative PCR tests locally at the end of September, after her partner’s son received a positive lateral flow test. They all had symptoms, but “secure in the knowledge that our continuing symptoms were not COVID”, the family went back to school, met friends and visited vulnerable relatives. And “the negative result meant that my partner went back to work – physical, manual work, which then made him a lot sicker and resulted in him being placed under the virtual hospital ward”, monitoring his oxygen levels remotely. He subsequently tested positive for COVID.

She added: “I feel completely betrayed. The text we were sent refers to ‘issues’ and ‘inconvenience’. If the situation wasn’t so serious, these words would be laughable.”

Like other residents, this family followed the official guidance, including advice issued in emails that I’ve seen from the Test and Trace service, stating: “If the follow-up [PCR] test is negative, you can stop self-isolating.” Unlike the advice on the NHS website, which is more cautious (advising people to stay at home if they are unwell, even if they receive a negative PCR), many locals were told in emails, as well as by call-handlers and test site staff, that their PCR result overruled everything else, including positive lateral flow tests and COVID-like symptoms.

Meanwhile, residents who applied for a £500 COVID support grant but who didn’t have a positive PCR test were refused on the basis of government rules, according to messages I’ve seen from the council.

The UK has some of the best publicly available local data on the pandemic. But why bother building that system if you don’t keep track of it, instead leaving it to voluntary groups like mine?

Although the government hasn’t said which areas of the south west were most affected, it’s clear that Gloucestershire is one of the worst hit areas in the country. For England as a whole, the number of COVID hospitalisations last week stood at 22% of the worst week in January 2021. But in Gloucestershire, we’re now at 41% of the January hospitalisation peak.

And in terms of cases, too, the most recent dashboard figures show 872 people per 100,000 tested positive here over the seven days to 24th October. In Stroud district, where I live, it was 964 . That’s double the England rate of 467. Stroud district has the second highest rate in the country, after neighbouring Tewkesbury, with other parts of Gloucestershire and neighbouring counties also showing very high rates. It's possible more people are getting tested and re-tested because of awareness generated by the scandal compared to other places, but the idea this would result in rates twice as high as across England as a whole is fanciful.

That is in stark contrast to where Gloucestershire was at the end of the summer. On 31 August, the rate was essentially the same as the England rate – 301 per 100,00, compared with 308 per 100,000.

According to the prime minister’s spokesperson, they “don’t believe [the lab error] accounts for the increases we have seen [in the south west]”. Such a statement is frankly insulting, and as health economist and mathematician Colin Angus pointed out in an excellent series of data visualisations, "incredible".

Local schools have ended up returning to remote learning, with large numbers of pupils and staff off sick with COVID. My own GP surgery has had to temporarily cease routine appointments due to clinicians isolating and I know of at least two practices in the district that are similarly affected.

The UK has some of the best publicly available hyper-local data on the pandemic. But all that dashboard data is next to worthless, if no one is actually looking at it seriously when issues like this arise. Why build a system that allows massive data crunching that should pick up any anomalies, why boast of your amazing data analytics capacities, if you then don’t bother keeping track of it, instead leaving it to local voluntary groups like mine?

Of course, if we had a properly local and supportive test and trace system, rather than a centralised and privatised one built by management consultants at huge expense, perhaps that system would have spotted the same pattern of anecdotes and data anomalies that I was noticing too.

What took them so long to act?

As the infection spread through and beyond our community, we weren’t the only ones spotting a problem, but getting stonewalled.

As far back as mid-September, members of the public had spotted the strange numbers across other parts of the south west and also suggested “there might be an issue with PCR labs”. Experts had also started raising concerns with the health authorities around the same time, Kit Yates told the Guardian in a recent podcast. For weeks, local schools were raising concerns but were effectively being told that the problem was down to people carrying out tests incorrectly.

By 7 October, I was so fed up with the national health authorities ignoring me, that I asked members of our local group – which has 5,500 members – to send examples of contradictory test results to them (by that point the issue had been transferred to a new agency, the UK Health Security Agency, UKHSA). By 11 October, the UKHSA said it did not need any more examples. I concluded that the problem had been identified. And, we now know, they suspended the Immensa lab the following day.

But it took them another four days before they made a public announcement – four days in which people with false negative results were still going about their lives and unwittingly spreading the infection.

Indeed, local health officials who I was in touch with privately told me that the problem had been identified and a public statement was expected, days before it eventually emerged. They were “furious” at the delay, I was told. A charitable reading would be that the government was getting its plan in order to communicate with the people affected. But given how bad that communication has been, I can’t help but suspect that it was more about getting themselves ready to manage the reputational damage to themselves and the company involved.

Neither the government, nor the company involved, have answered the most basic questions that I and openDemocracy have put to them. These include: when did they first become aware of the problem, and what did they do at that point?

Everything we’ve learned about this virus over the last 18 months shows that COVID needs to be addressed on a community level, not an individual, case-by-case basis. But we haven’t even been told officially which areas have been affected, let alone seen advice issued to those areas to be extra cautious.

The authorities are acting as if testing and tracing makes no difference. Almost everyone in my locality knows someone who has been affected. And now the rising consensus is, if tests don’t work, what’s the point of testing – which is the last thing we need.

It feels like hundreds of hours of voluntary effort to correct disinformation about COVID, to help people navigate the community guidance and the anxiety of the situation, have been undone. It’s absolutely gutting. And it’s horrible to think about the people who have ended up in hospital because of this.

It’s very hard to know precisely what the impact of this mistake has been because we’ve heard nothing from the UKHSA. They say they’re going to investigate the “precise cause” of the problem. But we’re demanding that they investigate the impact as well. When it comes to the public inquiry into COVID, this surely has to be part of it. As Alan McNally, a professor in microbial evolutionary genomics at the University of Birmingham, who helped set up the Lighthouse COVID testing lab at Milton Keynes, said; “In the long list of COVID disasters and scandals, this is pretty near the top.”

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