基于区块链技术的体外诊断试剂全流程智慧追溯体系应用研究

Research on Application of Intelligent Tracing System for IVD Reagents Based on Blockchain Technology

近年来,基于市场需求的不断扩增,体外诊断行业发展迅猛,在疾病预防、临床诊断、健康监测和指导治疗中发挥着重要作用,随之而来的体外诊断试剂的质量和安全问题也倍受关注。区块链技术特有的去中心化、去信任化、不可篡改的优势,在体外诊断试剂的生产、流通、使用等各个环节写入可信任的节点数据,建立起全量备份的分布式账本,为体外诊断试剂的防伪溯源提供了可能。讨论基于区块链技术搭建“体外诊断试剂全流程智慧追溯体系”,通过强有力的事前监督机制和事后惩罚机制,实现试剂来源可追、质量可查、责任可究,为检验医学质量和诊断安全保驾护航。

In recent years,the IVD industry has developed rapidly based on the increasing market demand,and plays an important role in disease prevention,clinical diagnosis,health monitoring and guiding treatment.Therefore,followed quality and safety issues are highly concerned.The unique advantages of blockchain technology,decentralization,distrust and non-tampering,can write into trusted node data in every link covering production,circulation and usage of IVD reagents,and establish a distributed ledger with full backup,which makes the anti-conterfeiting and traceability for IVD reagents possible.We discuss whole process intelligent tracing system for IVD reagents based on blockchain technology.Through the strong mechanism of pre-supervision and post-punishment,the source of reagents can be traced,quality and responsibility can be investigated,and the medical inspection quality and diagnostic safety can be guarded.