高兼容高通量全自动分子诊断平台的设计与验证OA

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.