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A second company obtained Public Health England approval to produce a Covid-19 antibody test, raising hopes that the virus can be successfully traced and contained in the UK.
The American multinational Abbott Laboratories has teamed up with the Swiss pharmaceutical company Roche to obtain the green light for PHE. The company said it was ready to send “5 million tests to the UK each month with immediate effect,” adding that it had already sent some to NHS laboratories it was “working closely with.”
Abbott’s lab test, which detects a previous infection with the virus, was endorsed by PHE on Thursday, hours after news emerged that its competitor Roche’s version had been successfully evaluated by the government agency. “The Abbott [test] it is now at the same stage as Roche, ”said PHE.
Governments hope that antibody testing is a key tool to track the spread of the virus and help decide how to facilitate blockages. Although the antibodies confer some degree of immunity to future infections, it is unclear how long such protection will last.
Widespread concerns about the accuracy of Covid-19 antibody tests, particularly rapid finger-stick devices, which are considered less reliable than laboratory tests, have made policy makers cautious about implementing them prematurely. But scientists hope that this may change soon.
Abbott’s Covid-19 antibody test has been approved by the public health authorities in England © Abbott
Downing Street said the antibody tests were a potential “game changer” and would “certainly” be available from the NHS. The Department of Health and Social Care added that it was “exploring the use of antibody testing throughout the NHS and, ultimately, in the general public.”
Roche, whose test was evaluated by PHE in just five days last week, said Wednesday that it was working closely with the NHS and the government to allow “a gradual implementation of the test as soon as possible.”
Since PHE is not a regulator, ministers will make any decisions about the deployment of the tests, although the NHS and policy makers seek guidance from the agency. Both Roche and Abbott products have received the CE mark indicating regulatory certification as diagnostic tests.
Scientists previously welcomed the news that PHE had endorsed Roche’s test, while warning of uncertainty about the strength and longevity of immunity conferred by antibodies to the virus.
“A better understanding of the immune response to the Sars-Cov-2 virus [which causes Covid-19] It will help us develop effective vaccines, “said Lawrence Young, a professor of molecular oncology at the University of Warwick.” This new antibody test will be an important weapon in the fight against the virus. “
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But Doris-Ann Williams, executive director of the British In Vitro Diagnostic Association, said there were “questions within the BIVDA membership about the apparent preselection of laboratory antibody tests from a small group of companies when others with tests with CE marked have not been selected for evaluation. “
There was also some confusion about the accuracy of the Roche test, after PHE said the test was 100 percent specific, which would mean there was no risk of false positives, but the company said it was 99.8 percent specific.
Matthew Baylis, president of veterinary epidemiology at the University of Liverpool, said that even that small difference would be significant if a low proportion of the population had the virus, as is likely to be the case. If 0.2 percent of the large number of people without antibodies had false-positive results, that could be a large number.
Abbott said his test had a specificity of between 99.7 and 100 percent. PHE did not disclose how many samples its evaluations were based on, but said the process independently verified the manufacturers’ claims.
Laboratory tests are not the same as fingerprinting self-assessment kits that the government said in March that they could soon be ready for sale to the general public, a claim that ministers have since remarked.
The government has asked a group of companies to develop a finger-stick antibody test that could be used at home. One of them, Omega Diagnostics, said Thursday that progress was continuing, but gave no guidance on when the test might be ready or when large-scale manufacturing could begin.
