Analytical validation of GMEX rapid point-of-care <i>CYP2C19</i> genotyping system for the CHANCE-2 trial
Xia Meng, Anxin Wang, Guojun Zhang, Siying Niu, Wei Li, Sifei Han, Fang Fang, Xingquan Zhao, Kehui Dong, Zening Jin, Huaguang Zheng, Kelin Chen, Hao Li, Chengyuan Yang, Yongjun Wang
Abstract
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<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.