摘要
目的了解北京市部分医院临床实验室血清肌酐检测的变异。方法以现场调查的方式向参加调查的13家实验室(31套检测系统)发放添加不同纯度肌酐标准物质的冰冻混合人血清样本8支(肌酐浓度80～1000 μmol/L),具不同浓度肌酐的患者冰冻混合血清样本8支,按照各实验室标准操作程序测定肌酐。结果对于添加不同纯度肌酐标准物质的冰冻混合人血清样本,实验室间各检测系统肌酐测定结果的总 CV 为5.74%～9.68%,Beckman 封闭检测系统测定结果的 CV 为2.64%～5.70%,碱性苦味酸动力学法开放检测系统的 CV 为5.96%～9.97%,酶法的 CV 为1.13%～8.95%;对于患者混合血清样本,总 CV 为5.90%～11.69%,Beckman 封闭检测系统的 CV 为2.53%～9.69%,碱性苦味酸动力学法开放系统的 CV 为5.92%～10.11%,酶法的 CV 为1.23%～10.30%。与 Beckman 封闭检测系统测定结果相比,Dade 检测系统(采用碱性苦味酸动力学法)测定所有血清肌酐结果的偏差为-5.99%～-0.35%,对于除 Dade 检测系统外的采用碱性苦味酸动力学法的其他检测系统,当血清肌酐浓度<200 μmol/L 时,测定结果偏高,且随肌酐浓度降低,正偏差增大,最大为11.85%,而在血清肌酐浓度>200 μmol/L 时,显示负偏差,最大为-8.45%;采用酶法的所有检测系统测定结果均为负偏差,最大可达到-8.88%。结论实验室间血清肌酐测定结果的变异较大,封闭检测系统测定结果的可比性好,开放检测系统测定结果可比性较差,酶法检测系统测定结果系统偏低。肌酐测定的标准化亟待解决。
Objective Understand the variation of serum creatinine measurement in clinical laboratories of some hospitals in Beijing. Methods 8 samples of mixed frozen human serum added different creatinine concentration standard materials （the creatinine concentration were80-1 000 μmol/L）and 8 samples of mixed frozen serum of patients （ contained different creatinine concentration ） were distributed to 13 clinical laboratories （31 series of detection systems） with the way of spot investigation. Every clinical laboratories measured the samples followed the standard operating procedure. Results As to the mixed frozen human serum added different creatinine standard materials, the CV of different detection systems results were 5.74% - 9.68% ; as to the mixed frozen patients＇ serum, the CV was 5.90% - 11.69%. Compared with Beckman closed detection systems, the results of Dade systems （which used the kinetic alkaline picric acid method） showed the bias were - 5.99% - 0. 35%, and as to the other systems which measured by alkaline picric acid method, when creatinine concentrations were 〈 200 μmol/L, the bias were positive, and increasing positive with the concentration lower, as much as 11.85% for the lowest concentration samples, however, when the concentrations of creatinine were 〉 200 μmol/L, the results showed negative bias, and the greatest bias was - 8.45%. The bias plots revealed negative for all of the detection systems with enzymatic method over the whole concentration range, and the greatest bias was -8. 88%. Conclusions The creatinine determination results of Beckman and Dade closed detection systems were consistent. The results of detection systems which used enzymatic method were generally lower than Beckman detection systems. What＇s more, the creatinine measurement variations of clinical laboratories were very large, especially for the results of unclosed detection systems, so it was urgent need to solve the standardization of creatinine measurement.
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2007年第11期1288-1292,共5页
Chinese Journal of Laboratory Medicine
关键词
肌酐
数据收集
实验室
Creatinine
Data collection
Laboratories
