Axed in the US, rapid tests we bought for £3bn

RAPID Covid tests used by millions of Britons each week have been branded a health risk and urgently recalled by officials in America.

The UK Government has spent around £2.8billion on the controversial Innova lateral flow devices, which are distributed by NHS Test and Trace.

Minsters touted the kits, which give a result within 30 minutes, as a way to safely get pupils back to school and employees into offices. But the US Food and Drug Administration (FDA) has told Americans to stop using them immediately and ‘destroy the tests’ by throwing them in the bin.

And the shock development could severely hit Boris Johnson’s so- called Operation Moonshot, where the Government has invested up to £37billion in what has been a troubled test and trace programme.

Last night, the UK’s medical regulator said it has launched its own review.

The FDA’s Class I recall – the most serious level – says there are ‘significant concerns’ that the accuracy of the test has not been ‘adequately established’ and the firm’s estimates of its clinical performance may be ‘misleading’. This means there is an unknown likelihood of false results, which could present a ‘risk to health’, it adds.

Infected people given a negative result may continue with their normal life, spreading the virus to colleagues or classmates.

And those wrongly told they are infected will unnecessarily miss school or work while self-isolating – and could be delayed seeking treatment for a real illness.

FDA inspectors also raised concerns about quality control at the firm’s premises. USbased Innova has produced more than a billion

‘Issues of concern’

tests for the UK market, where adults and children are entitled to two a week for free.

Almost 3.5million of the tests were used in the week to June 2 – down from 4.8million the previous week and the lowest for three months, latest figures show.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) granted an exceptional use authorisation for the NHSbranded version of the Innova test in December. It was valid for six months and is due for renewal on June 22.

Experts have long argued that the devices do not perform as well in real-life as they do in a lab – nor when used by the public, rather than professionals.

The tests missed 60 per cent of people with symptomless infections during a pilot test in Liverpool, including 30 per cent of those with very high viral loads, who are at most risk of spreading the virus to others.

The Innova website says its test identifies 97 per cent of infected people and returns a negative result for 99.9 per cent of those who do not have the virus.

But Professor Allyson Pollock, a public health expert at Newcastle University, said: ‘These tests are not reliable and the Government has wasted billions of pounds that could have gone to the NHS, education or social care.

‘The FDA ruling makes absolute sense and I’d now like to see the MHRA follow their example.’

Professor Jon Deeks, who has assessed tests at the University of Birmingham, described the FDA action as ‘somewhat troubling’.

He said yesterday: ‘There are issues of concern in the FDA decision, which the MHRA need to take seriously and look at carefully.’

A leaked email from the Department of Health revealed one official had warned up to 98 positive results from the lateral flow tests out of 100 could be wrong. A statement on the US recall said: ‘ The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health.’

But the Department of Health said: ‘The Innova test has already gone through the UK’s rigorous Porton Down assessment process, and we have a robust quality assurance process in place.

‘We have confidence in lateral flow tests, which help us identify people without symptoms but who could pass the virus to others – helping break the chains of transmission.’

Innova said it has worked ‘diligently’ to rectify the issues identified by the FDA at its offices in Pasadena, California.

The FDA has not authorised Innova rapid tests for use in the US and the firm said it had only been supplying them to employees, trials and some customers for ‘evaluation purposes’.

The rapid tests are for use by people without Covid symptoms and are intended to catch the one in three cases of infection that are asymptomatic.

People who test positive should isolate and get a confirmatory PCR test, which will allow officials to identify the variant.