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Der AYTU Test fällt doch unter Policy D oder nicht?
The guidance includes recommendations regarding:
• Validating newly developed serology tests that detect antibodies to SARS-CoV-2 prior
to clinical use
• Notifying FDA when clinical use of a validated test begins
• Indicating in test reports information along the lines of the following:
– This test has not been reviewed by the FDA
– 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.
www.google.com/...QIBhAC&usg=AOvVaw0416XkDpR1adzdHwRws40_
Welches Krankenhaus oder meinetwegen Regierung kauft das mit den Ausschlüssen?
The guidance includes recommendations regarding:
• Validating newly developed serology tests that detect antibodies to SARS-CoV-2 prior
to clinical use
• Notifying FDA when clinical use of a validated test begins
• Indicating in test reports information along the lines of the following:
– This test has not been reviewed by the FDA
– 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.
www.google.com/...QIBhAC&usg=AOvVaw0416XkDpR1adzdHwRws40_
Welches Krankenhaus oder meinetwegen Regierung kauft das mit den Ausschlüssen?
