Key points: 

  1. FDA issues first EUA for SARS-CoV2 IgM/IgG rapid test.
  2. This test is for laboratories that possess a non-waived CLIA certificate.
  3. There is currently no fingerstick claim for the use of this test.

Are any HFAP Standards affected?  No. This is provided for information only.

Read associated documents below.

qSARS-CoV-2 IgG/IgM Rapid Test

Healthcare Providers

Patients

Package Insert