国家神经系统疾病临床医学研究中心数据管理与共享系统

Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases

《国家中心数据管理与共享系统操作说明书 —— 研究者部分》

Analytical validation of GMEX rapid point-of-care CYP2C19 genotyping system for the CHANCE-2 trial

第一作者：Xia Meng,Anxin Wang,Guojun Zhang

通讯作者：Yongjun Wang

Validation; Point-of-care; CYP2C19

基本信息

2021-05-05

已发表文章

发表杂志：Stroke & Vascular Neurology

发表类型: Original Research

影响因子(IF): 4.765

PMID: 33952669 Pubmed原文链接 全文下载

主要研究背景及目的

Rapid genotyping is useful for guiding early antiplatelet therapy in patients with high-risk nondisabling ischaemic cerebrovascular events (HR-NICE). Conventional genetic testing methods used in CYP2C19 genotype-guided antiplatelet therapy for patients with HRNICE did not satisfy the needs of the Clopidogrel in HighRisk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE)-2 trial. Therefore, we developed the rapid-genotyping GMEX (point-of-care) system to meet the needs of the CHANCE-2 trial.

方法

Healthy individuals and patients with history of cardiovascular diseases (n=408) were enrolled from six centres of the CHANCE-2 trial. We compared the laboratory-based genomic test results with Sanger sequencing test results for accuracy verification. Next, we demonstrated the accuracy, timeliness and clinical operability of the GMEX system compared with laboratorybased technology (YZY Kit) to verify whether the GMEX system satisfies the needs of the CHANCE-2 trial.

结论

Our data suggest that the GMEX system is a reliable and feasible point-of-care system for rapid CYP2C19 genotyping for the CHANCE-2 trial or related clinical and research applications.

主要结果

Genotypes reported by the GMEX system showed 100% agreement with those determined by using the YZY Kit and Sanger sequencing for all three CYP2C19 alleles (*2, *3 and *17) tested. The average result’s turnaround times for the GMEX and YZY Kit methods were 85.0 (IQR: 85.0–86.0) and 1630.0 (IQR: 354.0–7594.0)min (p<0.001), respectively.