Department of Pathology, Pritzker School of Medicine, University of Chicago, Chicago, IL 60637-1470, USA.
Clin Chim Acta. 2011 May 12;412(11-12):1133-7. doi: 10.1016/j.cca.2011.03.001. Epub 2011 Mar 6.
CYP2C19 variants have been demonstrated to play an important role in determining response to clopidogrel and outcomes while on clopidogrel therapy. Predicting patient response through pre-therapeutic genotyping may therefore guide selection of antiplatelet therapy.
CYP2C19 genotypes were determined for 111 samples with the eSensor and compared with the Autogenomics expanded CYP2C19 panel, Luminex reagents, and bi-directional sequencing. Samples were obtained from the University of Chicago, ARUP Laboratories, and the Coriell repositories. Reproducibility studies were performed with 5 DNA samples with known CYP2C19 genotypes.
Complete concordance was observed for all samples and all platforms. DNA concentrations as low as 0.05 ng/μl may be used on the eSensor platform. There was 100% reproducibility observed with 2.5% incidence of invalid tests.
The eSensor CYP2C19 genotyping assay is accurate and compares well with 2 current commercial platforms. With a relatively rapid turn-around time of ~4 h and a high rate (97.5%) of valid tests, the eSensor can be translated into clinical use to identify slow and rapid metabolizers of clopidogrel who may benefit from alternate therapy or unconventional dosing of clopidogrel. An observed limitation of the eSensor is a maximum capacity of 24 tests/run.
CYP2C19 变体已被证明在确定氯吡格雷治疗反应和结局方面发挥重要作用。通过治疗前基因分型预测患者的反应，因此可以指导抗血小板治疗的选择。
使用 eSensor 确定了 111 个样本的 CYP2C19 基因型，并与 Autogenomics 扩展 CYP2C19 面板、Luminex 试剂和双向测序进行比较。样本来自芝加哥大学、ARUP 实验室和科里尔生物库。使用 5 个具有已知 CYP2C19 基因型的 DNA 样本进行了重复性研究。
所有样本和所有平台均完全一致。eSensor 平台上可以使用低至 0.05ng/μl 的 DNA 浓度。观察到 100%的重复性，无效测试的发生率为 2.5%。
eSensor CYP2C19 基因分型测定法准确，与 2 种当前的商业平台相比表现良好。eSensor 具有相对较快的周转时间（约 4 小时）和高（97.5%）有效测试率，可转化为临床使用，以识别氯吡格雷的慢代谢和快代谢者，他们可能受益于替代治疗或氯吡格雷非常规剂量。eSensor 的一个观察到的局限性是每次运行的最大测试容量为 24 个。
