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The page below is a sample from the LabCE course PCR Fundamentals: Focus on Multiplex PCR Assay and the Advantages over Singleplex Assays. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Definitions

Confusion has existed on the basic definitions of verification and validation in the past. To keep things simple, CMS has established the following :
Verification is the term used when dealing with an unmodified FDA approved assay.
Validation is the term used when dealing with a non-FDA approved assay (lab developed test [LDT])