Lateral Flow Testing for Workplaces - Are They Safe?

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23 June 2021

The US Food and Drug Agency has called into question the safety and efficacy of rapid lateral flow COVID-19 tests.

These rapid tests form the basis of the UK’s coronavirus testing programme, and have been recommended to help detect COVID-19 in people who are not showing symptoms.

According to an article published in the British Medical Journal, on 10 June 2021 The US Food and Drug Agency (FDA) warned the public to stop using the Innova SARS-CoV-2 antigen rapid qualitative test, suggesting they should be destroyed and binned.

An investigation carried out between March and April uncovered “significant concerns that the performance of the test has not been adequately established, presenting a risk to health.”

In addition, the FDA said that “labelling distributed with certain configurations of the test includes performance claims that did not accurately reflect the performance estimates observed during clinical studies,” and that the test “has not been authorised, cleared, or approved by the FDA for commercial distribution or use in the US, as required by law.”

Workplace Testing Programme

In February 2021, The Department of Health and Social Care started to work with key workplaces to ensure rapid testing was set up. Twelve UK organisations across almost 500 sites joined the government-backed rapid testing programme.

Lateral flow tests are now offered to everyone in England, with the government advising everyone to complete a test twice a week.

The idea behind the programme was that around one in three people who have coronavirus (COVID-19) have no symptoms and may be unknowingly spreading the virus. Testing will find more positive cases, keeping workers who cannot work from home unknowingly passing on the virus and protecting vital public services.

Some workplaces are also starting to keep records on employee vaccination status, including JP Morgan and Goldman Sachs. Staff at JP Morgan who have had two vaccine doses will reportedly not be required to wear face masks at work.

What Are the FDA's Concerns? 

Prof Jon Deeks, Professor of Biostatistics and head of the Biostatistics, Evidence Synthesis and Test Evaluation Research Group, University of Birmingham, commented:

“The FDA explain that they have withdrawn the Innova test for four main reasons: (a) distribution of the test in the US without approval; (b) erroneous claims on product leaflets; (c) concerns about the reliability of the evidence; and (d) failure to implement appropriate quality assurance processes to ensure that only inspected and approved devices are distributed."

“Given the issues raised, it is important that risk assessments are urgently undertaken in the UK by the manufacturer (which includes the Department of Health and Social Care for the repackaged NHS self-test) in consultation with the MHRA (the regulator) to assess whether similar risks occur with the supply and distribution of this test in the UK. 

Deeks also noted that the approval of the NHS branded self-test in the UK is a time-limited Emergency Use Approval which expires on the 22nd June 2021, and only for using the test for “test-to-find” purposes:

"Thus one would expect the review of these issues to be done quickly to allow decisions about ongoing use of the test to be made."

“There have been multiple issues with lack of transparency in the evidence to support the Government’s policies for use of this lateral flow test, which negatively impacts on uptake. Given the more serious concerns identified by the FDA, it is essential that full explanations and data are provided to explain decisions made about its continued use, if that is the decision made."

Innova SARS-CoV-2 Antigen Rapid Tests

In a statement to the British Medical Journal, Innova said it has “worked diligently and proactively to tackle the FDA findings,” adding that “none of the inspectional observations concern the performance of the test.” The company said, “We have voluntarily recalled the products as a result of labelling that was not consistent with FDA regulatory requirements. We are confident that we are on the pathway to fully comply with FDA requirements.”

Innova added, “Since Innova rapid antigen tests have not received EUA in the US, Innova is not shipping these products for commercial use. We intend to seek FDA authorisation to commercialise our rapid antigen test in the US.”

The Department of Health and Social Care states: "Lateral flow tests used by the UK government go through a rigorous evaluation by the country’s leading scientists. Tests detect cases with high levels of virus, making them effective in finding infectious individuals who are not showing any symptoms and are the most likely to transmit the disease."

Picture: a photograph of a person using a COVID lateral flow test

Article written by Ella Tansley | Published 23 June 2021

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