SARS-CoV-2 Antibody tests: "authorized" not the same as "CLIA-waived"

NCPA May 15, 2020

Pharmacies that are solicited to purchase SARS-CoV-2 (the virus causing COVID-19) antibody tests need to know that while tests may have EUA, they might not be authorized for the CLIA-waived point-of-care setting. Before you perform a test on a patient (molecular, antigen, or antibody) verify that the test is deemed to be authorized for the CLIA-waived setting by checking the list of test kit manufacturers with an FDA emergency use authorization. There must be a "W" in the column titled "authorized settings" for any test to be performed in a CLIA-waived laboratory. This includes test kits that are part of a telehealth bundle. Pharmacies that purchase antibody test kits in anticipation of the product becoming authorized for use in CLIA-waived settings do so at their own risk. For more information or help researching a company, email covid@ncpa.org or visit the NCPA coronavirus testing page.

NCPA