医学参考系统在我国IVD企业的应用与思考

Application and thinking of laboratory medical reference system in IVD enterprises of China

基于量值溯源的参考系统是检验医学领域重要的研究课题,也是体外诊断产品(IVD)企业提升产品质量和影响力的重要研究方向。检测结果的准确性和可靠性是临床科学诊断、治疗、预防疾病的重要保障。文章从IVD企业的角度对医学参考系统的基础情况和分类进行简要的阐述,从参考测量程序、参考物质、一致化研究3个方面介绍了参考系统在中国IVD企业中的应用;对目前参考方法和参考物质数量无法满足企业和临床应用需求、IVD行业对量值溯源和标准化的理解还不够完善、可提供参考测量服务的实验室网络缺乏等方面的问题进行归纳,期望为检验医学参考系统相关研究者提供参考。

The reference system research based on metrological traceability is an important research topic in the field of laboratory medicine,and it is also an important research direction for in vitro diagnosis product(IVD)enterprises to improve product quality and influence.The accuracy and reliability of test results are important guarantees for clinical diagnosis,treatment and prevention.In this review,from the perspective of IVD enterprises,basic situation and classification of medical reference system are briefly described.The reference system applied in IVD enterprises of China were introduced from the aspects of reference measurement procedures,reference materials and uniformity.The existing problems,such as the current number of reference methods and reference materials,can not meet the demand of enterprises and clinical applications,IVD industry understanding of metrological traceability and standardization is not perfectly enough,there is a lack of laboratory network for reference measuring service,were summarized.It is expected to provide a reference for the researchers of reference system of laboratory medicine.