Italian national and local authorities are undertaking extensive antibody testing campaigns to determine how many people may have developed immunity to the coronavirus. At the same time, the companies that make these tests — ranging from global players Abbott Laboratories and DiaSorin to local outfits such as Diesse Diagnostica and TechnoGenetics — are racing to win a share of an emerging market for tests that detect COVID-19 antibodies in the blood.
It’s not clear that all of these tests will provide solidly useful information. The WHO has warned against using them to issue so-called “immunity passports” — which would allow those who test positive for COVID-19 antibodies to resume a normal life — because experts still don’t know how long immunity lasts, or even whether antibodies can protect from reinfection. In the absence of a vaccine, Italy’s regional governments are using antibody tests — also called serological or blood tests — to gauge how many residents have been infected and allow certain employees to return to work if they test positive.
Faced with the choice of multiple tests offered by dozens of different companies, authorities are struggling to decide on a coherent strategy for testing. To make matters worse, many tests on the market are unreliable — researchers at UC San Francisco and UC Berkeley measured the efficacy of twelve different antibody tests and found that many kits had high rates of false positives. Regulators have grown increasingly cautious about certifying tests: The U.S. Food and Drug Administration announced on May 4 that it would ask test manufacturers to provide validation data within 10 business days or risk having their emergency authorizations revoked. In Italy, at least three regions — roughly the equivalent of U.S. states — initially banned private laboratories from offering antibody tests to the public.
Because of this variance between tests, Giordano suggests instead using only one, so at least any errors would be consistent, and therefore easier to account for. “It would be better to apply the same serological test in the whole country, to have a better picture of the diffusion of the virus throughout Italy,” he says.
Can Italy’s race for antibody testing be a sign of what’s to come for America?
Read the full profile on Forbes: https://www.forbes.com/sites/giacomotognini/2020/05/07/can-the-us-learn-from-italy-where-coronavirus-antibody-test-makers-are-fighting-for-a-new-market/#5a2d3d774628
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