Response to ‘When is a screening test not a screening test?’

We disagree that criticism of the United Kingdom Government’s approach to testing represents a ‘falling out’ amongst academics, apparently due to a narrow focus on the Wilson and Jungner criteria, and on test performance.¹

Concerns are based on (i) the persisting scientific uncertainty about the real-life performance of lateral flow devices when delivered by untrained hands and (ii) the consequences of widespread idiosyncratic testing without systematic quality assurance for all steps in the pathway.

The decision to spend well over £1 billion of public money on the Innova Biotime test was based on partial evidence, following a limited test validation process. Emergency regulatory approval, and repackaging of all the tests as though the Department of Health and Social Care was the actual manufacturer, then had to be secured in order to ‘retrofit’ the test to allow use outside the real manufacturer’s license. We still have no published evidence about how it performs when put to its current uses as an unsupervised self-test or in children.

The focus of concerns has been on the outcomes of the whole programme, not only on a single crucial element, the actual test, although the biases and flaws in evidence relating to test performance have been voiced by those with international expertise in this sphere,² an expertise vital to good health policy decision making. Other countries are deploying LFDs, but none has adopted the Innova Biotime test. For example, the basis of Germany’s LFD regulatory and evaluative approach is transparently and publicly set out. In the UK, this information is not disclosed by the Medicines and Healthcare products Regulatory Agency, even under Freedom of Information requests.

The author asserts that those who advocate for sound evidence and best value policy making processes for mass testing are misguided because they base their thinking on Wilson and Jungner. It seems to us the reverse is true, with this article ignoring the contemporary world of screening³ and relying instead on the 1968 publication as defense against suggestions that population-wide infectious disease testing should be informed by the standards and ethics required for screening programmes.