Validation Material

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Validation Material

Multiplex assays generate multiple, simultaneous results from a single sample. As such, these assays must always be verified/validated to achieve optimization. Note that the initial process in validation is now referred to as verification, while the ongoing performance process is referred to as validation.
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 regulatory organizations, obtained from reference laboratories, or by using shared specimens from other routine laboratories performing like assays.