Comment on Fears of ‘Wild West’ as Covid-19 blood tests hit the marketComments−asn0OP6ySummary:- > 70 companies have signed up with FDA to sell COVID-19 antibody tests, and are listed on the FDA's website[1]- FDA decided to waive initial review of the "simple" tests under COVID-19 emergency situation- companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected- some (unnamed) hospitals are incorrectly assuming the tests have been vetted- public health officials warn that the unregulated tests are creating confusion[1] Article doesn't provide a link, but I think this is the list. https://www.fda.gov/medical-devices/emergency-situations-med...
Comments
Summary:
- > 70 companies have signed up with FDA to sell COVID-19 antibody tests, and are listed on the FDA's website[1]
- FDA decided to waive initial review of the "simple" tests under COVID-19 emergency situation
- companies are supposed to state that their tests have not been FDA-approved and cannot rule out whether someone is currently infected
- some (unnamed) hospitals are incorrectly assuming the tests have been vetted
- public health officials warn that the unregulated tests are creating confusion
[1] Article doesn't provide a link, but I think this is the list. https://www.fda.gov/medical-devices/emergency-situations-med...