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The U.S. Food and Drug Administration ( FDA ) has issued more stringent rules forCOVID-19 antibody testssold in the U.S. , after a slew of antibody tests hit the market without adequate proof that they really shape , accord to news reports .
Under the new rules , society that are already sell these trial must commit the FDA an app for " emergency - exercise authorization " ( EUA ) , along with data indicate the test ' accuracy , within 10 business sector days , the agencysaid in a statement . ( An EUA allow medical products to be used under certain emergency situation , such as the COVID-19pandemic , without undergoing the typically extensive FDA approval cognitive operation . ) The test will also be expect to meet specific standards for accuracy .
antecedently , the FDA had reserve troupe selling COVID-19 antibody tests to validate their own datum , without undergo FDA review , fit in toThe Washington Post . This policy allowed more than 100 antibody trial to add up to food market without review from the agency , the Post reported . A number of these mental test were flawed or made unproven claims .
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" We unluckily see unscrupulous actors marketing deceitful test kit and using the pandemic as an chance to take advantage of Americans ’ anxiety , " the FDA command said . " Some test developer have falsely take their serological [ antibody ] trial are FDA approved or clear . Others have falsely claimed that their test can diagnose COVID-19 or that they are for at - domicile testing , " when the delegacy has not approved any antibody tests for at - home examination .
These antibody tests look for antibody that theimmune systemdevelops to agitate SARS - CoV-2 , the virus that causes COVID-19 . Antibody test can show if a soul has been infected with COVID-19 in the past , but they can not name a current contagion .
So far , 12 antibody trial have been clear under an EUA , the FDA said . The federal agency is also presently brush up more than 200 tests for emergency authorization .
If makers of antibody tests do n’t submit an EUA practical app within the 10 - day deadline , the FDA will make this information public and may take activeness to remove the trial from the market , the Post reported .
Originally published onLive Science .
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