The US Food and Drug Agency (FDA) has raised significant concerns about the rapid Covid test on which the UK government has based its multibillion-pound mass-testing programme.
In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to its California-based manufacturer Innova.
In the UK, these lateral flow Innova tests form the cornerstone of Operation Moonshot, the mass-testing scheme championed by the prime minister’s former chief adviser. The idea was that the ability to deliver results within 30 minutes – that need not be processed in a laboratory, provides a cheap, pragmatic and efficient way to identify people who have caught the virus but not fallen ill. But critics have raised concerns about accuracy.
Given the tests have been offered free to millions in England, for use at home or at test centres, workplaces and schools, with the aim of detecting more cases, breaking chains of transmission and saving lives since April – the FDA announcement is particularly damning.
The US agency has not authorised the use of the Innova test in the US, although the manufacturer has submitted a request for authorisation. But when the FDA discovered the Innova test was being distributed for US use regardless, it conducted an inspection of Innova’s medical device operations between March and April 2021.
In its report, the agency accused the company of “false or misleading” estimates of the test’s clinical performance, saying the estimates did not accurately reflect the performance of the diagnostic devices during clinical studies.
The FDA also highlighted that the clinical study data submitted by Innova as part of its request for US authorisation was identical to data previously provided by other manufacturers in separate requests.
In the UK, criticism of the Innova test has been fierce: the tests are not as effective as the gold-standard PCR tests, which can take days to produce results. The accuracy of the Innova tests also falls dramatically when administered by self-trained, non-healthcare workers versus lab scientists.
But perhaps the biggest concern is that the tests only tend to pick up cases when the person has high levels of the virus. Typically, when a person is first infected – they have low levels of virus.
The UK government’s first contract with Innova was agreed on 17 September, before the evaluation of its tests had been completed. In December, the Medicines and Healthcare products Regulatory Agency (MHRA) – which is an executive agency sponsored by the Department of Health and Social Care – accepted the DHSC’s request to issue special authorisation of the Innova test.
In early April, the UK government announced plans for the use of universal Covid-19 tests as a means to ease England out of lockdown. By the end of the month, the MHRA expressed concerns that the people who test negative would be given false reassurance by their result and would let down their guard if they believe they are Covid-free – suggesting the government’s universal testing plan was “a stretch” of the authorised use of rapid tests.
The MHRA’s special authorisation of the Innova test – which is repackaged and deployed by the NHS – is due for another review by 22 June.
“It is important to realise that the UK and EU process for assuring the safety of most medical tests is mainly based on trust – manufacturers’ provide notification that they abide by the required legislation – there is no scrutiny of the evidence,” said Jon Deeks, a professor of biostatistics at the University of Birmingham.
“It is time that this is changed to ensure that our regulator has the legal ability and independence to act in the right ways to protect the health of the public. Bad tests do harm.”
The Guardian has contacted the DSHC and MHRA for comment.