Analytical validation of GMEX rapid point-of-care CYP2C19 genotyping system for the CHANCE-2 trial. Issue 2 (5th May 2021)

• Record Type: Journal Article
• Authors: Meng, Xia; Wang, Anxin; Zhang, Guojun; Niu, Siying; Li, Wei; Han, Sifei; Fang, Fang; Zhao, Xingquan; Dong, Kehui; Jin, Zening; Zheng, Huaguang; Chen, Kelin; Li, Hao; Yang, Chengyuan; Wang, Yongjun
• Is Part Of: Stroke and vascular neurology. Volume 6:Issue 2(2021)
• Page Start: 274
• Page End: 279
• Publication Date: 2021-05-05
• Subjects: stroke -- genetic -- technology; Cerebrovascular disease -- Periodicals; Cardiovascular system -- Diseases -- Periodicals; 616.81005
• DOI: 10.1136/svn-2021-000874
• Languages: English
• ISSNs: 2059-8688

Abstract

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.