The US drug agency announced on Monday that it would monitor the commercialization of coronavirus serology tests more closely to help curb the proliferation of dubious tests.
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Laboratories manufacturing Covid-19 serological tests will now have to submit an "emergency use authorization" request to the United States Medicines Agency (FDA) and provide data proving the effectiveness of their tests under "ten days ” to continue to market them. Serological tests, which could be one of the keys to deconfinement, are done by blood test, and seek to detect the presence of antibodies that the body produces in reaction to the coronavirus. They allow in particular to identify people who have been infected, without necessarily showing symptoms.
Since mid-March, the flexible FDA rules that allowed companies to validate their results themselves and sell their tests directly, have led to the marketing of ineffective or ineffective tests, as an evaluation of American Institutes of Health (NIH). A report by about fifty scientists published on April 24, in addition, evaluated 14 serological tests and showed that only three presented reliable results in a constant way, as recalled by the New York Times. "Unfortunately, we see unscrupulous players advertising unreliable test kits and using the pandemic to take advantage of American anxiety," warned the FDA.
"Test manufacturers incorrectly claimed that their serological tests had been approved or authorized by the FDA," the agency added. So far 12 serological tests have been authorized by the FDA in emergency and more than 200 tests are being evaluated, she said. "These tests can be important to guide the next steps in the fight against the pandemic, by providing information on the prevalence of the disease and the frequency of asymptomatic infections , " said the FDA.
