2 ms·
Fears of ‘Wild West’ as Covid-19 blood tests hit the market
- asn0 6y agoSummary: - > 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-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-med...