WASHINGTON | The u.s. agency of medicines announced on Monday that it would monitor more closely the commercialization of serological tests for the coronavirus in order to fight against the proliferation of tests, and the reliability questionable.
Laboratories, manufacturer of serological tests of the Covid-19 will now be required to submit to the u.s. agency of the drug (FDA) a request for an “authorization of emergency use” and provide data proving the efficacy of their tests in the “ten days” to proceed to the market.
Serological tests, which could be one of the keys to déconfinement, are through the blood, and seek to detect the presence of antibodies that the body produces in response to sars coronavirus.
They allow, inter alia, identify persons who have been infected, without necessarily showing symptoms.
Since mid-march, the rules are flexible the FDA, which allowed companies to validate by themselves their results and selling their tests directly, have led to commercialization of tests for poorly performing or inefficient, as shown by an evaluation of the canadian Institutes of health us (NIH).
A report of fifty scientists published on the 24th of April, moreover, was evaluated 14 and serological tests showed that only three showed reliable results consistently, as noted by the New York Times.
“We see, unfortunately, some actors unscrupulous advertising test kits not reliable and that is using the pandemic to take advantage of the anxiety of the Americans,” warned the FDA.
“Manufacturers of tests have claimed, incorrectly, that their serological tests had been approved or authorized by the FDA,” added the agency.
Up to now 12 serological tests have been authorised in an emergency by the FDA and over 200 tests are being evaluated, she said.
“These tests may be important to guide the next steps in the fight against the pandemic, by providing information on the prevalence of disease and frequency of infections that are asymptomatic,” assured the FDA.