GMEX point-of-care genotyping system

XM Xia Meng
AW Anxin Wang
GZ Guojun Zhang
SN Siying Niu
WL Wei Li
SH Sifei Han
FF Fang Fang
XZ Xingquan Zhao
KD Kehui Dong
ZJ Zening Jin
HZ Huaguang Zheng
KC Kelin Chen
HL Hao Li
CY Chengyuan Yang
YW Yongjun Wang
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The GMEX point-of-care genotyping system was jointly developed by Chongqing Jingyin Bioscience and the China National Clinical Research Center for Neurological Diseases and was eventually transformed, produced and marketed by Chongqing Jingyin Bioscience. The GMEX system includes a portable DNA analyzer, genotyping reagents and a buccal sample collection kit. The system is user-friendly and can be easily operated, transmitted and analysed and presents an effective and simple approach to genotyping.

The operators associated with the GMEX system were doctors, nurses or clinical researchers. The GMEX system can be operated in the clinical department and bedside. Professional instructors trained all operators on-site and operators were assessed. Those that passed assessments obtained certificates. The training time for each hospital was about 2–4 hours.

The system uses noninvasive sampling by buccal swab at the bedside to improve patient compliance. It integrates automated steps of PCR-based amplification, fluorescent signal detection and genotype determination and is performed at the site of patient care by trained doctors, nurses or clinical researchers, dramatically improving the speed and user-friendliness of genotyping. The system has integrated controls to monitor the performance of a run and ensure ongoing quality of results. The innovative point-of-care test technology is in line with the affordable, sensitive, specific, user-friendly, rapid and robust, equipment-free and deliverable to end-users criteria proposed by the WHO.23 It is user-friendly, rapid and robust, equipment-free and deliverable to those who need them.

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