文章摘要
于婷,项新华,曲守方,孙楠,孙晶,李丽莉,黄杰.血清中总蛋白测定能力验证研究[J].中国药事,2020,34(10):1151-1157
血清中总蛋白测定能力验证研究
Study on the Proficiency Testing of the Serum Total Protein Determination
  
DOI:10.16153/j.1002-7777.2020.10.005
中文关键词: 血清总蛋白  能力验证  指定值
英文关键词: serum total protein  proficiency testing  assigned value
基金项目:
作者单位
于婷 中国食品药品检定研究院,北京 100050 
项新华 中国食品药品检定研究院,北京 100050 
曲守方 中国食品药品检定研究院,北京 100050 
孙楠 中国食品药品检定研究院,北京 100050 
孙晶 中国食品药品检定研究院,北京 100050 
李丽莉 中国食品药品检定研究院,北京 100050 
黄杰 中国食品药品检定研究院,北京 100050 
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中文摘要:
      目的:评价参与能力验证实验室的血清中总蛋白测定能力,提高检测水平。方法:按照CNAS相关文件要求,对真正的能力验证样本进行均匀性和稳定性检验,以参考方法测定值为指定值,对能力验证结果进行分析。要求真正的能力验证样本测定值应在指定值(67.03±3.46)g·L-1(k=2)范围内,全部样本(含干扰样本)测定值的RSD均应不大于2.0%。结果与结论:全部实验室(33家)均按要求提交了有效数据,其中有4家结果不满足要求,结果满意率为87.9%。大部分参加实验室的检测能力较好。根据上报信息,对于产生偏离的原因从总体上进行技术分析,并给出相关技术建议,以提升参加实验室的检验能力。
英文摘要:
      Objective: To evaluate the capacity of 1aboratories participating in the proficiency testing (PT) of serum total protein determination and to improve the quality of testing. Methods: According to the requirements of CNAS related documents, the homogeneity and stability of the real PT sample were evaluated. The value of real PT sample was assigned by reference method which was used in PT results assay. It is required that the measured value of the real PT sample should be within assigned value range (67.03 ± 3.46) g·L-1 (k=2), and the relative standard deviation (RSD) of value for all samples (including interference samples) should not be greater than 2.0%. Results and Conclusion: All the laboratories (33) participating in the PT submitted valid data according to the requirements. The results from 4 laboratories did not meet the requirements, and the satisfaction rate was 87.9%. Most of the laboratories participating in the PT had a good performance. According to collected information, a technical analysis in general was carried out to find out the deviation reasons and relevant technical suggestions were provided for promoting the testing ability of laboratories.
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