高兼容高通量全自动分子诊断平台的设计与验证
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R44;TP18

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Design and validation of a high-compatibility, high-throughput fully automated molecular diagnostic platform
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    摘要:

    目的:针对分子诊断技术操作繁琐、耗时长、实验室成本高及样本处理中人为因素影响准确性的问题,设计开发高通量、高兼容性的全自动分子诊断平台。方法:LabEasy 8000全自动分子诊断平台,通过模块化整合试剂制备、核酸提取、聚合酶链式反应(PCR)等流程,搭载人工智能(AI)辅助识别系统并兼容国产主流PCR试剂。结果:该平台实现单项目24 h 8 000例检测通量、多项目2 400例并行检测;经天隆科技Gentier 96R系统验证,乙型肝炎病毒(HBV)和丙型肝炎病毒(HCV)检测偏差<0.5 log IU/mL(100%检出率),批内精密度变异系数(CV)<5%,检测限达10 IU/mL。结论:该平台可有效提升分子诊断效率与准确性,为国产全自动分子诊断设备开发提供技术参考。

    Abstract:

    Objective: To address the issues of complex operations, time consumption, high laboratory costs in molecular diagnostic technology, and the impact of human factors on accuracy during sample processing, a high-compatibility and high-throughput fully automated molecular diagnostic platform was developed. Methods: The LabEasy 8,000 Fully Automated Molecular Diagnostic Platform was designed, integrating reagent preparation, nucleic acid extraction, and PCR amplification processes through modular design, equipped with an AI-assisted recognition system, and compatible with mainstream domestic PCR reagents. Results: The platform achieved a detection throughput of 8,000 tests per single assay within 24 hours and 2,400 concurrent tests for multiple assays. Validated by the Gentier 96R fully automated PCR analysis system, the detection deviation for Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) was less than 0.5 log IU/mL (100% detection rate), the intra-assay coefficient of variation (CV) was less than 5%, and the limit of detection (LOD) reached 10 IU/mL. Conclusion: The platform can effectively improve the efficiency and accuracy of molecular diagnosis, providing a technical reference for the development of domestic fully automated molecular diagnostic equipment.

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刘天予;张冠斌;严治.高兼容高通量全自动分子诊断平台的设计与验证[J].川北医学院学报,2026,41(4):428-434.

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  • 在线发布日期: 2026-05-06
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