TY - JOUR T1 - Analytical validation of GMEX rapid point-of-care <em>CYP2C19</em> genotyping system for the CHANCE-2 trial JF - Stroke and Vascular Neurology JO - Stroke Vasc Neurol DO - 10.1136/svn-2021-000874 SP - svn-2021-000874 AU - Xia Meng AU - Anxin Wang AU - Guojun Zhang AU - Siying Niu AU - Wei Li AU - Sifei Han AU - Fang Fang AU - Xingquan Zhao AU - Kehui Dong AU - Zening Jin AU - Huaguang Zheng AU - Kelin Chen AU - Hao Li AU - Chengyuan Yang AU - Yongjun Wang Y1 - 2021/05/05 UR - http://svn.bmj.com/content/early/2021/05/05/svn-2021-000874.abstract N2 - Background and purpose 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 HR-NICE did not satisfy the needs of the Clopidogrel in High-Risk 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.Methods 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 laboratory-based technology (YZY Kit) to verify whether the GMEX system satisfies the needs of the CHANCE-2 trial.Results 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&lt;0.001), respectively.Conclusions 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.Data are available upon reasonable request. Data in this article are available upon reasonable request. ER -