体外诊断试剂能力验证应用策略探讨

Discussion on Proficiency Testing Strategy for in vitro Diagnostic Reagents

目的:探讨体外诊断检测领域能力验证策略,为能力验证提供者组织能力验证活动提供参考,推动实验室质量体系持续改进。方法:通过对组织体外诊断检测领域能力验证活动的工作进行总结,从方案设计到结果分析所涉及的关键环节进行梳理剖析,只有将这些关键环节进行有效的质量控制,才能成功地开展能力验证活动。结果与结论:能力验证提供者持续改进质量体系建设,为实验室提供质量评价保障的同时,推动了实验室间结果的一致性和标准化。

Objective： To explore the proficiency testing strategy in the field of in vitro diagnostic testing, to provide references for proficiency testing providers and to promote the continuous improvement of the laboratory quality system. Methods： The work of the proficiency testing activities in the field of in vitro diagnostic testing was summarized. The key points from the project design to the results were analyzed. If only the quality control of the key points were achieved, the proficiency testing activities could be successfully carried out. Results and Conclusion： The proficiency testing providers should continuously improve the quality control system, provide the quality evaluation for the laboratory and to promote consistency and standardization of inter-laboratory results.