A Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver is a certification that allows a healthcare entity (professional or facility) to perform simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. As determined by the Food and Drug Administration (FDA), the CareStartTM COVID-19 Antigen test falls under this category and therefore the entity performing the test must have a certificate of waiver prior to testing.
The CLIA waiver number is a ten-character alpha-numeric code that is issued by the Centers for Medicare & Medicaid Services (CMS) upon application review and approval. Sites that perform waived testing must have this certificate and should follow the manufacturer's instructions for collection.
