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Fears of ‘Wild West’ as Covid-19 blood tests hit the market

2 pointsby asn0about 5 years ago

1 comment

asn0about 5 years ago
Summary:<p>- &gt; 70 companies have signed up with FDA to sell COVID-19 antibody tests, and are listed on the FDA&#x27;s website[1]<p>- FDA decided to waive initial review of the &quot;simple&quot; tests under COVID-19 emergency situation<p>- companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected<p>- some (unnamed) hospitals are incorrectly assuming the tests have been vetted<p>- public health officials warn that the unregulated tests are creating confusion<p>[1] Article doesn&#x27;t provide a link, but I think this is the list. <a href="https:&#x2F;&#x2F;www.fda.gov&#x2F;medical-devices&#x2F;emergency-situations-medical-devices&#x2F;emergency-use-authorizations" rel="nofollow">https:&#x2F;&#x2F;www.fda.gov&#x2F;medical-devices&#x2F;emergency-situations-med...</a>