FDA approves first point-of-care antibody test

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FDA approves first point-of-care antibody test
Damareus Barbour CA
Sep 24, 2020

The Food and Drug Administration today authorized for emergency use the first serology test to help identify individuals with antibodies to SARS-CoV-2 at the point of care.

The agency previously authorized the test for use by certain labs. 

“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test,” noted FDA Commissioner Stephen Hahn, M.D.
 

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FDA approves first point-of-care antibody test
Damareus Barbour CA
Sep 24, 2020

The Food and Drug Administration today authorized for emergency use the first serology test to help identify individuals with antibodies to SARS-CoV-2 at the point of care.

The agency previously authorized the test for use by certain labs. 

“Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test,” noted FDA Commissioner Stephen Hahn, M.D.
 

COVID-19: CDC, FDA and CMS Guidance

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