Lateral Flow Test – Moonshot crashes without survivors

OK – once again you’ll not have heard any of this on the BBC, so it’s worth a sketchy report of some dramatic results. This is about the government’s piloting of the “Moonshot” testing scheme using a new quicker and much cheaper test than PCR, called a Lateral Flow Test.

This test detects proteins rather than amplifying RNA fragments like PCR. It’s against the latter that it must, unfortunately, be evaluated, because (as I’ve said before) there is no gold standard viral assay. The biggest difference is that it misses around a quarter of positive PCRs, but given the now well-known problems of false positives due largely to excessive cycle thresholds, this is a good thing. It appears to detect a good percentage of those with a high viral load – in other words real COVID infections that may well pose an infective risk.

Furthermore it has high specificity, so that its estimated false positive rate in clinical conditions is about 0.32%. []

So, the pilot study was rushed into action as a screening programme using army personnel, because of the serious “spike” in the north of England. Volunteer subjects got both a Lateral Flow test and a PCR. As of 4 days ago 90,000 people in Liverpool – a recent hot spot put under newly-invented Tier 4 lockdown before was joined by the general lockdown – had been tested, and the Lateral Flow test had revealed 336 positives. []

The first impression from this is that the PCR results causing national lockdown must have been orders of magnitude too high. But worse still, expressed as a percentage the positives make up 0.37% – almost the same as the false positive rate. As Dr Mike Yeadon has concluded, it seems probable there is little or no COVID-19 in Liverpool at all, especially since the deaths attributed to it exactly match missing deaths that would have been expected from other causes in a normal year. This may not prove Britain is suffering a PCR Casedemic, as some of us have been saying for months, and no longer a pandemic, but it certainly suggests it strongly.

In a rational world a major pause would be made to evaluate these data, but locally it looks as though the plan is to accept positives from either method as a reason for self-quarantine, and to roll out the national program as quickly and expensively as possible across the country without evaluation of the pilots. And this is what government by experts and “following the science” means in practice.

And this leads me to yesterday’s BMJ, which has an editorial on the roll-out of the screening programme. Of interest to me, to begin with, are the authors, who both match the criterion of trustworthy because retired or independent of government and industry – but they are not at all under-credentialled, as I will now show.

The main author, Mike Gill, is a former regional director of public health. His co-author, Prof Sir Muir Gray, I have actually corresponded with accidentally. A few years before I retired I got in a spat with a local private urologist over prostate screening, and after reading the NHS screening service article on why they didn’t recommend it, I e-mailed them questioning why this was, since it didn’t quite make sense to me. What I got back was a crash correspondence course in epidemiology from this guy “Muir Gray.” Only when I looked him up after a few fruitful exchanges did I realize he was the head of the entire UK screening service. As a result I went into the debate I organised with the surgeon, at a local medical meeting, very well briefed indeed.

When such a man writes a BMJ editorial on a screening program, you had better take it seriously. Any Chief Scientist or Chief Medical Officer (for example!) who ignores it betrays incompetence or malice. We don’t get very far in before the authors say this:

This is a screening programme, not opportunistic case finding: people are invited to have a test they would not otherwise have had, or asked for. If judged against the criteria drawn up by the UK’s National Screening Committee for appraisal of a programme’s viability, effectiveness, and appropriateness, it does not do well and has been already roundly criticised.

Non medics seldom realise just how tight the necessary criteria for screening programmes are, and why – they can cause immense harm both medically and economically, and only a select few reach the standard. This one – without having to read between any lines – is crap. The next paragraph continues:

Despite claims by the city council that the Innova test is “very accurate with high sensitivity and specificity,” it has not been evaluated in these conditions. The test’s instructions for use state that it should not be used on asymptomatic people. A preliminary evaluation from Porton Down and Oxford University throws little light on its performance in asymptomatic people or in the field. It suggests the test misses between one in two and one in four cases. The false positive rate of 0.6% means that at the current prevalence in Liverpool, for every person found truly positive, at least one other may be wrongly required to self-isolate. As prevalence drops, this will become much worse.

I’m not sure how the figures here relate to the figures from the source I quoted at the top, but the overall message is the same: a high percentage of cases will be missed, and a high percentage will be false positives. There will be plenty of ill effects on quarantined people from the latter, and plenty of people to keep infections spreading from the former – that is, if there is actually any significant amount of COVID-19 still around. But hey, the programme only costs £100 billion, plus the many billions in lost jobs and production… it is our national gold reserved flushed down the drain, and then some. All it will benefit is the Great Reset, by hastening the demise of people’s private property and making them dependent on the State. Though not as happy as the WEF posters suggest.

The editorial goes on:

The council claims, wrongly, that the test detects infectiousness and is accurate. In fact, if used alone it will lead to many incorrect results with potentially substantial consequences. The context for gaining consent has been tarnished by the enthusiasm of some local officials and politicians.

The last point is true, but the real fault lies with national, more than local, politicians who hatched the scheme. The best way I can leave this post with you is to quote the final paragraphs of the BMJ article. It’s a pretty damning indictment of the whole shambles of our government’s – and probably your government’s – embracing of track and trace systems that fly in the face of all good practice.

There is no protocol for this pilot in the public domain, let alone systems specification or ethical approval. The public has had no chance to contribute, as required by the UK standards for public involvement in research.

Spending the equivalent of 77% of the NHS annual revenue budget on an unevaluated underdesigned national programme leading to a regressive, insufficiently supported intervention—in many cases for the wrong people—cannot be defended. The experience of the National Screening Committee and National Institute for Health Research (NIHR) tells us that allowing testing programmes to drift into use without the right system in place leads to a mess, and the more resources invested the bigger the mess. This system should be designed with up to 10 clear objectives to deliver the aim of reducing the impact of covid—for example, to identify cases more quickly or to mitigate the effects of deprivation on risk of infection and poor outcomes. Progress in each objective (or lack of it) should be measured against explicit criteria. Screening programmes based on experience and on the literature relating to complex adaptive systems offer a model for rapid progress.

At a minimum, there should be an immediate pause, until the fundamental building blocks of this mass testing programme have been externally and independently scrutinised by the National Screening Committee and NIHR. In the meantime, nobody’s freedom or behaviour should be made contingent on having had a novel rapid test. It is premature to offer testing as the route to individuals’ release from restrictions. Instead we must heed the advice of the World Health Organization and the government’s Scientific Advisory Group for Emergencies (SAGE), radically improve the woeful performance of the “find, test, trace, and isolate” system, and renew the focus on identifying symptomatic people, especially among those sections of society most at risk. The current approach will open Pandora’s box. []

I can’t resist adding that that last sentence returns us to the Prometheus theme I have blamed for modern ills since I wrote God’s Good Earth.

Jon Garvey

About Jon Garvey

Training in medicine (which was my career), social psychology and theology. Interests in most things, but especially the science-faith interface. The rest of my time, though, is spent writing, playing and recording music.
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3 Responses to Lateral Flow Test – Moonshot crashes without survivors

  1. Peter Hickman says:

    My medical education included learning about the Wilson criteria for effective screening, which are as follows:

    * the condition should be an important health problem
    * the natural history of the condition should be understood
    * there should be a recognisable latent or early symptomatic stage
    * there should be a test that is easy to perform and interpret, acceptable, accurate, reliable, sensitive and specific
    * there should be an accepted treatment recognised for the disease
    * treatment should be more effective if started early
    * there should be a policy on who should be treated
    * diagnosis and treatment should be cost-effective
    * case-finding should be a continuous process

    The WHO has a similar list.
    It is not difficult to see that both the PCR Test and the Lateral Flow Test miserably fail to meet a number of these criteria.

    • Jon Garvey Jon Garvey says:

      Yeah, but when you only spend £100 billion, what do you expect?

      • Jon Garvey Jon Garvey says:

        One memory I didn’t mention is attending an open session of discussion on breast screening by breast-cancer experts, when I was a med student.

        I went in assuming that it was a no-brainer, and soon learned some of the problems and complexities even from clinicians with, I imagine, a sketchy knowlede of epidemiology.

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