Dataset Information

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

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.

SUBMITTER: Meng X

PROVIDER: S-EPMC8258065 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Publications

Analytical validation of GMEX rapid point-of-care <i>CYP2C19</i> genotyping system for the CHANCE-2 trial.

Meng Xia X Wang Anxin A Zhang Guojun G Niu Siying S Li Wei W Han Sifei S Fang Fang F Zhao Xingquan X Dong Kehui K Jin Zening Z Zheng Huaguang H Chen Kelin K Li Hao H Yang Chengyuan C Wang Yongjun Y

Stroke and vascular neurology 20210505 2

<h4>Background and purpose</h4>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 <i>CYP2C19</i> 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 ...[more]

PMID: 33952669

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