Advertisement

Rapid Covid tests used by schoolchildren investigated for containing wrong instructions

A student takes a lateral flow test at Outwood Academy in Doncaster, Yorks - PA
A student takes a lateral flow test at Outwood Academy in Doncaster, Yorks - PA
Coronavirus Article Bar with counter
Coronavirus Article Bar with counter

Chinese-made lateral flow tests handed to millions of schoolchildren are being investigated by the regulator after being sent out with the wrong instructions, The Telegraph can reveal.

Devices have been handed out accompanied by out-of-date guidance that states they can be used if a person has symptoms.

The boxes also contained a “confusing” notice from their Chinese manufacturer erroneously saying that the tests were for use by people “suspected of Covid-19 by their healthcare provider”.

This contradicts the Government’s stated purpose for its mass rollout of the 30-minute turnaround tests, which is to catch infections in asymptomatic individuals, believed to comprise one in three Covid carriers.

People with symptoms are supposed to get a PCR laboratory test, the results of which are reported automatically, triggering the contact tracing process.

Experts warned on Sunday that if people with symptoms think it is permissible to use only a lateral flow test then they may not report their positive result, self-isolate, or give contact tracers the chance to reach others they may have infected.

The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed it is investigating the issue.

It comes after leaked emails revealed that health officials fear the devices could pick up “on an optimistic assumption” only 10 per cent of infections when self-administered, and suggested they are considering scaling back the programme.

Tens of millions of the devices are being used in schools, where children are required to be tested twice weekly.

Lateral flow tests Q&A
Lateral flow tests Q&A

Meanwhile the Government this month invited all asymptomatic adults to use them to have a test twice a week in order to break chains of transmission as society reopens.

However, testing kits have been given out to school children as recently as this month with an accompanying government leaflet – “Version 1.1.4, 24 November 2020” – which states: “You can use this self-test kit if you have symptoms or if you are asymptomatic (you do not have symptoms)”.

As well as the November leaflet, which comes in the lateral flow device box, some children, but not all, are being handed by teachers a more up-to-date document: “Version 1.3.2, 15th January 2021."

However, there is no equivalent guidance in this version, it merely states that users should refer to NHS guidance online if they have symptoms. The boxes also contain a leaflet from the manufacturer, Xiamen, which could imply that the tests are only to be used by people suspected of having Covid by a clinician.

Professor Allyson Pollock, a public health expert at Newcastle University, said: "The whole mass testing programme is confusing, chaotic and the antithesis of good public health practice.

“If you do mass testing you need to do proper evaluation beforehand, which would identify problems like this.”

“Lateral flow testing should have gone through the UK National Screening Committee for proper evaluation.”

She added: “Mass testing is a complex public health intervention and is no different from medicines and vaccines – there is real potential for harm.”

Another scientist, whose children were given the out-of-date leaflet, described the packages as "deeply confusing".

"If symptomatic people use lateral flow instead and fail to report their result, then we'll lose control and it won't give contact tracers a chance," they said.

A recent Cochrane review – an analysis of 64 studies – found that the less effective devices pick up about 72 per cent of symptomatic cases, and only 58 per cent of infections where the person was asymptomatic. This applied to the Innova test, which is used very widely in the UK.

The findings have led some experts to predict, as levels of coronavirus in the community decline, that mass testing with lateral flow devices will do more harm than good by throwing up more false positives than true ones.

However, the Government is staunchly backing the programme.

On Friday a Downing Street spokesman said lateral flow tests had been “rigorously evaluated and we believe they are both accurate and incredibly useful in terms of being able to spot asymptomatic cases of the virus”.

A spokesman for MHRA said: “I can confirm that we are looking into this.”