我国血细胞分析参考系统的建立

Reference system for completed blood count

为了解决血液分析仪的校准存在的问题,卫生部临床检验中心按照国际血液学标准化委员会和国际标准化组织颁布的国际标准,在部中心建立了血细胞计数的参考系统,研究的主要内容包括:(1)建立了血细胞分析校准实验室,并作为医学实验室中的首家实验室通过了国家实验室认可委员会ISO17025校准实验室的认可;(2)首次在国内建立了血细胞分析的参考方法并与国外的参考实验室长期进行结果的比对;(3)使用参考系统定值的新鲜血或校准物为常规检测实验室提供校准服务,开辟了血液分析仪校准的新途径;(4)建立了二级标准检测系统的方法并与国外参考实验室进行长期的结果比对,同时将经验推广到全国26个省、自治区、直辖市,建立了比对实验室网络;(5)起草了多个卫生部行业标准和技术要求。目前该系统的应用领域主要包括:临床检验中心、医疗机构的临床实验室、体外诊断试剂的政府管理机构、疾病控制系统等。

A reference system for the completed blood count （CBC） have been established in National Center for Clinical Laboratory （NCCL） according to the standards published by InternationalCouncil for Standardization in Hematology （ICSH） and International Organization for Standardization （ISO）in order to calibrate hematology analyzer. The contents of our study mainly include ： （ 1 ） Establishment ofcalibration laboratory for CBC, which is the first calibration laboratory accepted by China NationalAccreditation Board for Laboratories in all medical laboratories. （2） We firstly set up the reference method for CBC in China. In addition, the data between NCCL and a foreign reference laboratory have been compared.（3） We have calibrated some instruments from routine laboratories by the fresh blood or calibrator valuatedby the reference system, which acts as a new way to calibrate hematology analyzer. （4） A secondary standardassay system has been established and the data between it and the foreign reference laboratory have beencompared chronically. The experience has been introduced to local laboratories in 26 provinces. （5） Wehave drafted out several documents about technical standard for laboratory medicine. The main institution ofapplications includes： local center for clinical laboratory, clinical laboratories for routine examination,institutions for identification to instruments and reagents, centers for disease control and prevention, and soon.