Article
Proposals for a standardized procedure of validation of DNA extraction and allelic discrimination assays in pharmacogenomics according to ISO15189 requirements.
Pharmacogenetics and genomics - 1 Jul 2022
Imbert Laurent, Lagoutte-Renosi Jennifer, Wils Julien, Lamoureux Fabien
Abstract excerpt
OBJECTIVES: In the era of quality management in clinical laboratories, method validation can be a challenge without appropriate guidelines, such as in the field of pharmacogenetics. The present work describes a method validation for DNA extraction and CYP3A5*3 genotyping, which would meet ISO15189:2012 requirements. METHODS: DNA extraction was performed using a QIAamp DSP DNA Blood kit, DNA purity and...
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