Table 2.
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 |