LONDON – It was advertised as a potential corona virus game changer, a breakthrough that would allow millions of people to resume their daily lives within a few days.
Governments and corporations around the world trust the idea of an “antibody test” – a self-administered fingerprint kit that is used to determine whether someone has had the coronavirus in the past and, above all, has built up immunity.
But initial optimism was dampened this week after leading British scientists found that none of the tests they had tried so far were accurate enough to be useful. The UK government, whose Prime Minister Boris Johnson is in ICU with symptoms of COVID-19, the coronavirus disease, said it has ordered millions of the kits and is now seeking reimbursement.
“Unfortunately, the tests we’ve looked at so far haven’t worked well,” said Sir John Bell, a professor at Oxford University who led the tests for the British government. wrote in a blog post Sunday. “We see a lot of false negatives … and we also see false positives.”
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The UK “is now uniquely positioned to evaluate and find the optimal test for this disease,” but no country has found a standard kit, he said.
Finding one “should be reachable,” but it will take at least a month, he added.
His views were shared by leading US infectious disease expert Dr. Anthony Fauci, who confirmed on Wednesday to JAMA, the Journal of the American Medical Association, said: “You need to validate the tests [or] Otherwise, take a path that would be very misleading. “
The British results came days after the Spanish government returned another delivery of inaccurate antibody tests purchased from a European company that they sourced in China.
Unlike the nasal and throat swabs that tell you whether you currently have COVID-19, the antibody test – also known as a serology test – is a bit like a pregnancy test with results on a series of lines on a strip. Completion takes only 20 minutes and can be done at home or in a pharmacy.
Theoretically, it could be determined whether people already had the virus, even if they had shown no symptoms. This could allow people to continue their daily lives with confidence that they have built up some immunity.
Governments in London and Berlin have already circulated the idea that these people could get “immunity certificates” to show that they are not a threat to themselves or others.
This led to fears that some people might seek infection to recover and get back to work, but for those who really survived the virus, it promised some degree of freedom.
Some officials said this was the first step in an exit strategy, while making bold predictions about when the tests might be available.
“This will happen this week,” said Sharon Peacock, director of the United Kingdom’s National Infection Service, on March 25, suggesting that the tests would be available from Amazon and pharmacies. “In the near future, people will be able to order tests that they can do themselves.”
With social barriers continuing to take time to find a vaccine across much of the world, testing is seen as critical to tracking and fighting the disease.
In the United States, the Food and Drug Administration issues its first emergency approval for the tests.
Scanwell Health, a Los Angeles-based digital health company, is applying for government approval for a kit that allows users to send scanned images of blood tests to doctors on their phones.
Theoretically, the tests are easy to manage, but quite complex. They would require that blood that a test subject donated prior to the onset of the epidemic be available to detect false positives that could be derived from antibodies to other types of coronavirus.
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The mantra among experts is that the only thing worse than no test is a bad test. So if you mistakenly tell thousands of people that they are immune, it can be catastrophic.
According to the UK Department of Health and Social Affairs, there are around 100 kits on the market, but no government has developed an antibody testing program that meets the required standards – comments from Franco Locatelli, head of Italy’s Higher Health Council.
Spain returned an unspecified number of antibody tests purchased from a European intermediary using a Chinese supplier, and Dr. María José Sierra, deputy director of the country’s emergency coordination center, said Monday that the accuracy of the test was only 64 percent.
In Germany, the Ministry of Health warned anyone thinking of buying rapid antibody tests online that the kits are likely to be inaccurate.
There is a significant risk that “the person being tested is already highly contagious and imagines that he is safe”.
CORRECTION (April 8, 2020, 11:25 p.m. ET): In an earlier version of this article, the name of the U.S. agency that regulates drugs for safety reasons was incorrectly specified. It is the Food and Drug Administration, not the Federal Drug Administration.