AI Article Synopsis
- The study emphasizes the importance of validating pharmacogenetics (PGx) procedures in clinical labs to ensure they meet necessary standards before being used on patients.
- A validation process for an in-house PGx PCR-based method showed 100% concordance, repeatability, and reproducibility, with high sensitivity and specificity for several key genes, except for some limitations in detecting CYP2C19 variants.
- Successful integration of pharmacogenetic testing in clinical settings relies on accurate genotyping, and the research confirms that their laboratory assay meets critical quality requirements despite some limitations.
Article Abstract
Objective: The implementation of pharmacogenetics (PGx) in clinical practice is an essential tool for personalized medicine. However, clinical laboratories must validate their procedures before being used to perform PGx studies in patients, in order to confirm that they are adequate for the intended purposes.
Methods: We designed a validation process for our in-house pharmacogenetic PCR-based method assay.
Results: The concordance to reference, repeatability and reproducibility was 100%. Sensitivity and specificity were 100% for the detection of variant diplotypes in CYP2C9, CYP3A5, TPMT, DPYD and UGT1A1 genes. The sensitivity was lower in the detection of CYP2C19 variants due to a limitation in the design that prevents the detection of CYP2C19 *2/*10 diplotype.
Conclusions: The success of implementing clinical pharmacogenetic testing into routine clinical practice is dependent on the precision of genotyping. Limitations must be bearing in mind to guarantee the quality of PGx assays in clinical laboratory practice. We provided objective evidence that the necessary requirements in our laboratory-development assay were fulfilled.
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| http://dx.doi.org/10.1097/FPC.0000000000000438 | DOI Listing |
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