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Evaluation of Manufacture and Quality Controls for PCR Components Used in Molecular Diagnostic Assays

Part # PS249

Abstract

Rod Pennington, Kathryn Oostdik, Jennifer Mook, Sarah Wheeler, Leta Steffen, Katharine Hoffman, Tom Lubben, Terri McDonnell, Doug Storts
Promega Corporation, Madison, WI

Robust and reliable MDx amplification assays require assay components that are manufactured under controlled processes and meet QC specifications that qualify the component to contain minimal contaminants that could negatively impact the assay’s performance. The enzyme is the most common focus for evaluation of potential contaminants, but all amplification components have the potential for lot-to-lot variability and contamination. Using amplification components with a common baseline for quality provides confidence in assay development, which facilitates focus assay development on performance and not troubleshooting amplification component quality.

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