The devices are seen as crucial for targeting asymptomatic cases, enabling different sectors of society, such as care and entertainment, to reopen their doors. Having spent more than £700m on the kits, the government is hopeful they can provide the bedrock for its mass-testing strategy.
Care homes across the country are refusing to implement the rapid testing devices rolled out by the government due to concerns over their accuracy and safety.
More than a million lateral flow tests (LFT), which can return a Covid result within 30 minutes, have been distributed to England’s 385 biggest care homes as part of plans to allow family visits over the Christmas period.
However, research released by the government’s Scientific Advisory Group for Emergencies (Sage) has shown that the tests – produced by Innova, a US-based company – are capable of picking up only 48.9 per cent of active infections.
This has sparked major concerns within the hard-hit care industry, with providers fearful that the tests could be returning false results and allowing Covid-positive visitors into homes.
Diagnostics experts have warned that the tests are endangering lives throughout the UK – universities, schools and hospitals have similarly rolled out the devices – and called upon the government to withdraw the LFTs.
One care home told The Independent that it had “no confidence” in the tests and said it would not be using them, having consulted with its residents’ relatives and the local council.
“They’re totally unreliable,” said Lucy Craig, who owns two care homes in Northumberland and Newcastle Upon Tyne. “We’ve discussed it and decided it’s a risk to people’s health and safety that none of us are prepared to take.
“We don’t want to risk Covid coming back into the building when we are so close to getting the vaccine. If we were to get another positive case, our residents couldn’t be vaccinated for a minimum of 28 days under the guidance.”
Ms Craig said her care home in Newcastle, West Farm Care Centre, had recently reported 12 deaths, 41 infections among residents and 38 positive staff cases following a devastating outbreak. “I don’t want to fall at the final hurdle after the 10 months we’ve had,” she added. “The tests aren’t worth it.”
Sage’s findings were based on data taken from 3,199 people who participated in the mass testing pilot carried out in Liverpool last month. Researchers at the University of Liverpool also found that the Innova test failed to detect three in 10 positive cases with high viral loads.
The study revealed that the city’s Health Protection Board was forced to pause its testing pilot in care homes, which had allowed people to visit elderly relatives, due to “the accuracy statistics”.
Liverpool council resumed the scheme in 11 of the city’s care homes on 3 December, but only after requiring visitors to have two lateral flow tests and a confirmatory PCR test – the gold standard for Covid testing – before entering the building.
Garden Lodge Care Home, which is involved in the pilot, told The Independent that authorities were still gathering data on the accuracy of the devices.
The National Care Association (NCA) said it was “concerned” by the messaging put out by the government regarding the LFTs.
Guidance from the Department of Health and Social Care states that lateral flow devices are “not a fool proof solution” and “find at least half of the cases that PCR testing detect”, but Nadra Ahmed, chair of the NCA, says many providers feel like they’ve been left in the dark.
“What we’ve heard back from some providers is that there’s no acknowledgement [from the government] of the risk,” Ms Ahmed told The Independent.
“We are getting some providers saying they’re not going to use it, others are saying they are using it but are absolutely adamant that we must have the PPE and the social distancing in place.
“Some providers say they’ve had to take at least one full additional member of staff just to sort the visiting arrangements, the testing arrangements – all of these things. Some are saying that they’ve got as many as two full-time staff to deal with the guidance.
“That’s an additional cost to provide which is just not acknowledged. Additionally, we’re doing all of these things without any indemnity insurance in place to cover outbreaks.”
Surrey Care Association (SCA) told The Independent it has “grave reservations” over the decision to use the tests to open up care homes for Christmas, when people will be moving across the country and helping to spread Covid-19.
Simon Carter, chair of the SCA, said his members “do not regard lateral flow tests to be sufficiently reliable in determining whether or not it is safe to admit a visitor into their homes.”
He added: “Knowing this, and understanding too that the manufacturers of the lateral flow tests advise against using the tests in care settings, it would be reckless and irresponsible for our members to admit visitors simply because they’ve returned a negative test result.