Introduction

Before a molecular test is used to report patient results, it is the responsibility of each laboratory to determine (or verify) and document that the claims of the assay are accurate, reproducible, and sound. This verification process is established for each assay that a clinical laboratory performs, be it a molecular, serological, or microbiological assay. The verification process is not limited to in-house developed procedures ("home-brew" assays), but is required prior to the use of commercially available Food and Drug Administration (FDA)-approved assays or reagents as well. A well-designed verification will define the performance characteristics of the assay and the possible results generated by the assay.

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