Use of Plasmid-Derived External Quality Control Samples in Pharmacogenetic Testing

Abstract

Genetic variation in genes encoding for drug-metabolizing enzymes, drug targets and signaling pathways have proven to contribute significantly to differences in drug response. Pharmacogenetics is now expanding from clinical pharmacological research to its application in clinical practice. Genotyping of patients in a routine clinical setting requires robust and reliable genotyping methods. A survey of pharmacogenetic association studies for quality control samples published from 2005 to 2007 in the two most prominent pharmacogenetic journals, and development of plasmid-derived external controls. Surveying journals revealed that only a minority of papers report the use of quality controls, and no standard procedures are applied. We established 12 plasmid-derived external controls and applied these in pharmacogenetic testing. There still is a need for quality control materials, especially for application in pharmacogenetic testing. We hope that our initiative to create plasmid-derived controls will help to facilitate quality in the pharmacogenetic genotyping tests applied in research, as well as in routine patient care.