文章摘要
苗玉发,顾玥,张琳,王超,黄芝瑛,王雪,潘东升,吕建军,张河战.非临床实验室对心肾功能生化指标检测能力的验证[J].中国药事,2019,33(2):182-187
非临床实验室对心肾功能生化指标检测能力的验证
Proficiency Testing on Biochemical Indicators of Heart and Kidney Function at Non-clinical Laboratories
投稿时间:2018-05-30  
DOI:10.16153/j.1002-7777.2019.02.011
中文关键词: 心肌酶  肾功能  能力验证
英文关键词: myocardial enzymes  kidney function  proficiency testing
基金项目:国家“重大新药创制”科技重大专项(编号2018ZX09201017)
作者单位E-mail
苗玉发 中国食品药品检定研究院, 北京 100176  
顾玥 中山大学药学院, 广州 510006  
张琳 中国食品药品检定研究院, 北京 100176  
王超 中国食品药品检定研究院, 北京 100176  
黄芝瑛 中山大学药学院, 广州 510006  
王雪 中国食品药品检定研究院, 北京 100176  
潘东升 中国食品药品检定研究院, 北京 100176  
吕建军 中国食品药品检定研究院, 北京 100176  
张河战 中国食品药品检定研究院, 北京 100176 zhanghz@nifdc.org.cn 
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中文摘要:
      目的:评价检测实验室对肌酸激酶、乳酸脱氢酶、血清肌酐和血尿素4种生化指标的检测能力。方法:分别采用单因素方差分析和t检验对能力验证样品的均匀性和稳定性进行了研究。对能力验证数据进行正态性检验,按照能力验证评价标准,对各实验室的结果进行评价。结果:肌酸激酶满意率为95%,乳酸脱氢酶满意率为96.9%,血尿素满意率为87.8%,血清肌酐满意率为95.3%。结论:部分实验室的心肌酶和肾功生化指标检测能力有缺陷,实验室的检测质量需要改进。
英文摘要:
      Objective: To evaluate the detection abilities of four biochemical of clinical laboratories:creatine kinase (CK), lactic dehydrogenase (LDH),serum creatinine (CRE) and blood urea (UREA). Methods: The uniformity and stability of proficiency testing samples were analyzed by one-way ANOVA and t test respectively. Data distribution of proficiency testing was analyzed by normality test and the proficiency testing results were evaluated according to evaluation criteria. Results: The satisfaction rate of CK was 95%, the satisfaction rate of LDH was 96.9%, the satisfaction rate of UREA was 87.8% and the satisfaction rate of CRE was 95.3%. Conclusion: The defects of detection ability of biochemical indicators of myocardial enzymes and kidney function were discovered in several laboratories, and the detection quality of the laboratories needs to be improved.
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