Intended for healthcare professionals


Covid-19: MHRA is concerned over use of rapid lateral flow devices for mass testing

BMJ 2021; 373 doi: (Published 28 April 2021) Cite this as: BMJ 2021;373:n1090

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  1. Gareth Iacobucci
  1. The BMJ

The UK’s medicines regulator is understood to have raised concerns that the government’s mass testing programme for covid-19 is a “stretch” of its authorisation for how rapid lateral flow tests should be used.

Although the Medicines and Healthcare Products Regulatory Agency approved the Innova rapid lateral flow test to detect cases of SARS-CoV-2 infection at home,1 it has emphasised that negative results should not be used as a green light for people to change their behaviour and be less cautious.

The Guardian reported that the MHRA had told officials at the Department of Health and Social Care for England that the government’s use of rapid lateral flow tests in its mass testing programme risked giving false reassurance to people who tested negative and had asked the department to provide evidence on the accuracy of the tests in real life situations and to start a public information campaign to explain the risks and benefits of mass testing.2

The multibillion pound programme to test people without covid symptoms, details of which were first revealed by The BMJ last September,3 was expanded on 9 April to offer everyone in England access to twice weekly rapid testing.4

But experts have warned that empirical evidence was lacking to show that lateral flow devices were effective at detecting SARS-CoV-2 in asymptomatic people who tested themselves. A recently published Cochrane review found that the tests correctly identified an average of 58% of people who were infected,5 but the number of samples from asymptomatic people was around a 10th that from symptomatic people in the studies, limiting the conclusions that could be drawn.

When approached by The BMJ the MHRA did not deny that it had raised concerns with the health department. In a statement Graeme Tunbridge, director of devices at the agency, said, “The MHRA is working closely with NHS Test and Trace to ensure the tests are used in appropriate situations according to the available evidence.

“No test is 100% reliable, even those that meet regulatory standards for performance and safety. Even with a negative test result people must continue to follow national and local rules and guidelines, including regular handwashing, social distancing, and wearing face coverings, where required.”

In an editorial published in The BMJ this week the public health consultants Angela Raffle and Mike Gill argued that encouraging all adults to test themselves at home twice a week was a “misguided policy, unlikely to reduce transmission.”6

“In addition to concerns about the cost and ineffectiveness of asymptomatic testing, self-reported results from asymptomatic people are already skewing nationwide data on test numbers, cases, and positivity rates, making trends harder to interpret,” they wrote.

“False positive results will be a problem when prevalence is low, even with PCR confirmation. And the temptation for people with symptoms to opt for unsupervised, rapid, and lower sensitivity self-testing may lead to false reassurance, as happens with other screening, leading to potential increases in transmission.”

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