Analytical validation of a psychiatric pharmacogenomic test

被引:28
作者
Jablonski, Michael R. [1 ]
King, Nina [1 ]
Wang, Yongbao [1 ]
Winner, Joel G. [1 ]
Watterson, Lucas R. [1 ]
Gunselman, Sandra [1 ]
Dechairo, Bryan M. [1 ]
机构
[1] Assurex Hlth Inc, Mason, OH 45040 USA
关键词
analytical validation; combinatorial pharmacogenomics; genetic testing; neuropsychiatric conditions; pharmacogenomics; IMPACT; HYPERSENSITIVITY; CARBAMAZEPINE; ASSOCIATION; PAROXETINE; CYP2D6; DRUG; HLA;
D O I
10.2217/pme-2017-0094
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Aim: The aim of this study was to validate the analytical performance of a combinatorial pharmacogenomics test designed to aid in the appropriate medication selection for neuropsychiatric conditions. Materials & methods: Genomic DNA was isolated from buccal swabs. Twelve genes (65 variants/alleles) associated with psychotropic medication metabolism, side effects, and mechanisms of actions were evaluated by bead array, MALDI-TOF mass spectrometry, and/or capillary electrophoresis methods (GeneSight Psychotropic, Assurex Health, Inc.). Results: The combinatorial pharmacogenomics test has a dynamic range of 2.5-20 ng/mu l of input genomic DNA, with comparable performance for all assays included in the test. Both the precision and accuracy of the test were > 99.9%, with individual gene components between 99.4 and 100%. Conclusion: This study demonstrates that the combinatorial pharmacogenomics test is robust and reproducible, making it suitable for clinical use.
引用
收藏
页码:189 / 197
页数:9
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