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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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Validation Material

Multiplex assays generate multiple, simultaneous results from a single sample. As such, these assays must always be verified (if non-FDA approved)/validated (if unmodified FDA approved) to achieve optimization.
One of the most challenging aspects of implementing a multiplex PCR, whether it be a laboratory developed test (LDT) or a commercially available test (FDA approved), is obtaining adequate control material for the verification and validation process. These may be purchased through a number of commercial vendors, obtained from: standardized material from regulatory organizations; proficiency testing material; reference laboratories; known values from patient samples, or; by using shared specimens from other routine laboratories performing like assays.