Table 2.

Definitions of terms.

Term	Definition
Clinical Assay	Any test being used to generate results that will be used diagnostically and may influence clinical decisions about a patient.
Clinical Laboratory Accreditation	A process to ensure the quality of results generated meet ISO 15189 standards
User Required Specifications (URS)	The required performance of a clinical assay, as defined by the clinical users either within an institution or nationally/internationally by a consensus publication
Validation	Analysis of performance characteristics to ensure that the assay meets the URS
Verification	Confirmation of performance characteristics of a commercial kit to ensure that the assay meets the URS