血清中尿酸及尿素测定能力验证研究  

Study on proficiency testing of the determination of uric acid and urea in serum

作　　者：张娟丽 于婷[2] 沈敏 马丽颖[2] 李丽莉[2] 孙晶 ZHANG Juan-li;YU Ting;SHEN Min(Henan Institute of Medical Device Inspections,Zhengzhou 450003,China;不详)

机构地区：[1]河南省医疗器械检验所,河南郑州450003 [2]中国食品药品检定研究院,北京100050 [3]美康生物参考实验室,浙江宁波315104

出　　处：《中国医学装备》2021年第4期40-44,共5页China Medical Equipment

基　　金：国家重点研发计划(2019YFF0216504)“临床质谱诊断试剂量值溯源及质量评价研究”。

摘　　要：目的:评价参与能力验证(PT)实验室的血清中尿酸和尿素测定能力,以提升检测水平。方法:选取14个省(自治区)、直辖市的16家医疗器械检验所、食品药品检验机构、疾病控制中心、质量监督检测研究院及其他科研单位的实验室,按照中国合格评定国家认可委员会(CNAS)的相关文件要求,对实验室全部样本中的真正PT样本进行稳定性和均匀性评价,以参考方法测定值为靶值,对实验室的测定结果进行分析。要求真正的PT样本中尿酸和尿素测定值与靶值的相对偏差应分别为≤±10.0%和≤±15.0%;全部样本(含干扰样本)中尿酸及尿素测定值的变异系数(CV)均应≤3.0%。结果:全部实验室(16家)结果均为满意,满足尿酸测定值偏差≤±10.0%,尿素测定值与靶值的相对偏差≤±15.0%;全部样本(含干扰样本)中尿酸及尿素测定值的CV均≤3.0%。真正PT样本在稳定性评价中,于-20℃和2~8℃冷链运输条件下样本稳定性可得到保障;均匀性评价中F值均<F_(0.05)值,表明均匀性良好。结论:参加PT的实验室检测尿酸和尿素测定能力均准确可靠。Objective:To evaluate the determination abilities of 1 aboratories participated in the proficiency testing(PT)of uric acid and urea in serum so as to improve the detection level.Methods:16 laboratories from 14 provinces(autonomous regions)and municipalities directly under the central government were selected,including laboratories of medical device inspection institute,food and drug inspection institution,center for disease control,quality supervision and testing institute and other scientific research institutions.According to the requirements of related documents of China National Accreditation Service for Conformity Assessment(CNAS),the stability and uniformity of the real PT sample were evaluated.The measured value of reference method was used as target value to analyze the results of various laboratories.It was required that the relative deviation of uric acid and urea in real PT sample between the measured value and the target value shall be less than or equal to±10.0%,and less than or equal to±15.0%,respectively.And the coefficient of variation(CV)of the measured values of uric acid and urea in all of samples(included interference samples)should less than or equal to 3.0%.Results:The results of all 16 laboratories were satisfactory,which met the requirements that the relative deviation of measured value of uric acid was less than or equal to±10.0%and the relative deviation of the measured value and target value of urea was less than or equal to 15.0%,respectively.The CV of the measured values of uric acid and urea in all samples(including interference samples)was less than 3.0%.In the stability evaluation of PT samples,the stability of PT samples could be guaranteed under the cold chain transportation conditions with-20℃and 28℃.In the uniformity evaluation,the F values of uric acid and urea were all less than F_(0.05),which indicated the uniformities of them were favorable.Conclusion:The determination abilities of laboratories participated in the PT for uric acid and urea are accurate and reliable.

关 键 词：能力验证(PT) 尿酸 尿素 靶值 实验室 

分 类 号：R446.1[医药卫生—诊断学]