Web: | mayocliniclabs.com |
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Email: | mcl@mayo.edu |
Telephone: | 800-533-1710 |
International: | +1 855-379-3115 |
Values are valid only on day of printing. |
Manufacture of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) convalescent plasma units
This test should not be used to exclude active or recent coronavirus disease 2019 (COVID-19).
This test should only be used to manufacture coronavirus disease 2019 (COVID-19) convalescent plasma units.
This test detects antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike glycoprotein and will not distinguish between antibodies generated due to natural SARS-CoV-2 infection versus a vaccine-induced response.
See FDA guidance for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) convalescent plasma units: www.fda.gov/media/141480/download
Fact sheet for emergency use authorization (EUA) for convalescent plasma for healthcare providers: www.fda.gov/media/141478/download
Fact sheets for this EUA assay can be found at the following links:
For healthcare providers: www.fda.gov/media/137361/download
For patients: www.fda.gov/media/137362/download
Chemiluminescence Immunoassay (CLIA)