Performance Specification Verification of Assays Authorized Under Emergency Use (EUA)

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Performance Specification Verification of Assays Authorized Under Emergency Use (EUA)
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The Centers for Medicare & Medicaid Services (CMS) is providing guidance to surveyors, specifically if surveyors find a laboratory using an assay without an EUA that is testing for the same agent for which an emergency has been declared, or a modified EUA assay, they should notify their Regional Office (RO).
 Assays that have been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) remain subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) CLIA Regulations
 At the onset of a public health emergency, there may be a very limited number of positive samples available for the verification of performance specifications. This does not necessarily prevent laboratories from utilizing assays authorized by an EUA.
 Centers for Disease Control (CDC) Developed Assays: Laboratories using a CDC assay authorized for emergency use should follow any and all instructions provided for verifying performance specifications.
 Non-CDC Developed Assays: For other non-CDC EUA assays, the Laboratory Director (LD) should determine the acceptable number of positive and negative samples needed for their laboratory to verify performance specifications of the EUA assay. In accordance with 42 CFR §493.1252(a), any manufacturer’s instructions for verification, if provided, must also be followed. The surveyor should confirm that the laboratory has followed its procedures for verification.