Right I see
I guess anytime I see the expression "fda approval" I wonder what that means exactly.
"Last month, the FDA said it wouldn’t authorize these types of tests the same way as molecular diagnostics. The agency described them as less complex, and said it would not object to their unreviewed use as long as they were clinically validated and not used as the sole method to diagnose an infection."
In my opinion "not objecting" isn't equal to "approval"
I'm sure many would, and will, disagree but in my opinion, to my knowledge, the only blood test for antibodies "approved" by FDA is Cellex's. The rest are "not objected" to.
Could PRED but the text "FDA APPROVED" on their packaging ? I highly doubt it.
Instead I see the need for the following as per FDA website :
Laboratories and healthcare providers must include this information in their patient test report as specified in FDA guidance:
This test has not been reviewed by FDA (how can they "approve of something they haven't reviewed ?)
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
"Approval" doesn't seem like the right word to me.
But I could be wrong. If so help me see it.
