Data Management And Sharing System of China National Clinical Research Center for Neurological Diseases
Analytical validation of GMEX rapid point-of-care CYP2C19 genotyping system for the CHANCE-2 trial
First author：Xia Meng,Anxin Wang,Guojun Zhang
Corresponding author：Yongjun Wang
essential_information
- Person in charge：Xia Meng,Anxin Wang,Guojun Zhang
- Data Sources： CHANCE-2
- Number of papers：CHANCE-220210065
- Published time：2021-05-05
2021-05-05
Published articles
Journal：Stroke & Vascular Neurology
Publication type: Original Research
IF(IF): 4.765
PMID: 33952669 Link To Pubmed Full text Download
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 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.
Method
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.
Conclusion
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.
Main 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.