Update on Use of COVID -19 Antigen Tests

Jackie Pappalardi and Lisa Volk in Clinical & Quality

Use of COVID -19 Antigen Tests

NYSDOH Wadsworth Laboratory shared that there are currently two SARS-CoV-2 antigen tests that have been authorized by the FDA for used as a waived/point of care test.  While less sensitive than the PCR lab-based tests, the Department supports use of these assays when they are used in accordance with the FDA Emergency Use Authorization (EUA) guidance provided in the Information for Use (IFU) document provided at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.  Scroll down to “Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2” and the list is shown.  The IFU for the tests can be found under “Authorization Documents”. 

NYSHFA/NYSCAL CONTACTS:

Jackie Pappalardi, RN, BSN
Executive Director
518-462-4800 x16

Lisa Volk, RN, B.P.S., LNHA
Director, Clinical & Quality Services
518-462-4800 x15