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锂、钠、钾、镁、钙、氯复合电解质冰冻人血清国家标准品的研制和性能评价 预览

Development and performance evaluation of the national standard materials of lithium,sodium, potassium,magnesium,calcium and chlorine in compound frozen human serum
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摘要 目的研制锂、钠、钾、镁、钙、氯复合电解质冰冻人血清国家标准品,并评价其性能,促进锂、钠、钾、镁、钙、氯电解质测定的标准化。方法收集含不同浓度锂、钠、钾、镁、钙、氯离子的无溶血、脂血和黄疸血清,经多重过滤、除菌后分装,制备成3个水平的候选品,-70℃保存。以钾离子作为均匀性评价的特性量,采用单因素方差分析评价候选品的均匀性。以钾、钠、氯离子作为稳定性评价的特性量,采用线性回归分析评价候选品的稳定性。采用参考方法或经验证的方法定值,并计算不确定度。评估候选品、新鲜血清样本在参考方法或经验证的方法与4个常规检测系统间的互通性。结果3个水平侯选品中,钾离子的均匀性检验F值分别为1.6301、1.4986和1.0208,均<F0.05;钾、钠、氯离子在2~8℃、20~25℃和-20℃条件下,均至少可稳定30d。3个水平侯选品中,锂离子定值结果分别为(0.649±0.022)、(1.195±0.032)、(1.334±0.008)mmol/L(k=2),钠离子定值结果分别为(120.057±2.206)、(142.030±1.521)、(158.228±1.293)mmol/L(k=2),钾离子定值结果分别为(5.042±0.143)、(5.739±0.106)、(6.158±0.094)mmol/L(k=2),镁离子定值结果分别为(0.732±0.021)、(0.857±0.026)、(1.144±0.026)mmol/L(k=2),钙离子定值结果分别为(2.014±0.078)、(2.348±0.056)、(3.070±0.024)mmol/L(k=2),氯离子定值结果分别为(90.814±2.005)、(108.875±0.908)、(128.156±1.453)mmol/L(k=2)。钠、钾、镁、钙和氯离子3个水平侯选品浓度均在新鲜血清样本的95%可信区间内,互通性良好。结论制备的锂、钠、钾、镁、钙、氯复合电解质冰冻人血清国家标准品候选品均匀性、稳定性好,钠、钾、镁、钙和氯离子侯选品互通性良好,定值准确可靠,可作为国家标准品使用。 Objective To develop the national standard materials of lithium,sodium,potassium, magnesium,calcium and chlorine in compound frozen human serum and evaluate their performance,and to promote the standardization of lithium,sodium,potassium,magnesium,calcium and chlorine assays. Methods Serum samples without hemolysis,lipemia and choleplania were collected. After multiple filtration sterilization,serum pools were packed in ampoules in 3 levels' candidates and stored in -70 ℃. Potassium ion is used as a characteristic parameter for homogeneity evaluation by single factor analysis of variance. Potassium,sodium and chlorine ions were used as the characteristic parameters for stability evaluation by linear regression analysis. The value was assigned by reference methods or validated methods,and the uncertainty was calculated. The commutability of fresh serum samples between reference methods/validated methods and 4 conventional analysis systems was evaluated. Results The F values of homogeneity for potassium ion in 3 levels' candidates were 1.630 1,1.498 6 and 1.020 8,respectively. All of them were <F0.05. The stabilities of potassium, sodium and chlorine ions can be last at least 30 d at -20 ℃, 2-8 ℃ and 20-25 ℃. The assigned values for lithium,sodium,potassium,magnesium,calcium and chlorine ions were:lithium 0.649±0.022,1.195±0.032 and (1.334±0.008) mmol/L;sodium 120.057±2.206,142.030±1.521 and (158.228±1.293) mmol/L;potassium 5.042±0.143,5.739±0.106 and (6.158±0.094) mmol/L;magnesium 0.732±0.021,0.857±0.026 and (1.144±0.026) mmol/L;calcium 2.014±0.078,2.348±0.056 and (3.070±0.024) mmol/L;chlorine 90.814±2.005,108.875±0.908 and (128.156±1.453) mmol/L(k=2). The linearities for sodium,potassium,magnesium,calcium and chlorine ions were all within 95% confidence intervals,and the commutability was good. Conclusions The homogeneity and stability of candidates all meet the requirement,and their values are assigned accurately and reliably. The commutabilities of sodium,potassium, magnesium,calcium a
作者 于婷 沈敏 曲守方 黄杰 YU Ting;SHEN Min;QU Shoufang;HUANG Jie(Division of In Vitro Diagnostics for Non-infectious Diseases,the National Institutes for Food and Drug Control,Key Laboratory of Method and Standardization for Quality Control of Biotechnical Products,Beijing 100050,China;Reference Laboratory Medicalsystem Biotechnology Co.,Ltd., Ningbo 315104,Zhejiang,China)
出处 《检验医学》 CAS 2019年第5期457-462,共6页 Laboratory Medicine
关键词 冰冻人血清 国家标准品 Lithium Sodium Potassium Magnesium Calcium Chlorine Frozen human serum National standard material
作者简介 于婷,女,1978年生,博士,研究员,主要从事体外诊断试剂检定和标准物质研制工作;通信作者:黄杰,E-mail:jhuang5522@126.com。
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