我国肌酐检测系统性能分析

Analysis on the performance of creatinine testing system in China

目的研究我国肌酐检测系统的检测性能。方法通过向全国1 402家实验室发放5个不同浓度批次的质评物,进行肌酐检测的实验室室间调查,同时收集各实验室2011年5月肌酐室内质量控制(IQC)信息,按照2种检测方法(苦味酸法和酶法)和11套检测系统分组分析。计算各检测系统室间质量评价(EQA)结果,剔除离群值后的均值(x珋)、标准差(s)、变异系数(CV)。以1/3允许总误差(TEa)和基于生物学变异的质量规范判断各检测系统的不精密度水平。采用各实验室EQA的平均偏差作为偏倚估计,IQC累积CV作为不精密度估计,计算各实验室的西格玛(σ)水平。结果 EQA结果分析中,苦味酸法组CV范围为1.03%～18.23%,酶法组为1.50%～8.08%。苦味酸法组中Beckman检测系统实验室间的变异情况较其他系统好,Beckman UniCel系列检测系统CV范围为3.13%～4.90%。酶法组中以HITACHI系列(Roche)检测系统的变异情况优于其余各组,CV为1.50%～3.00%。IQC结果分析中,80%以上的实验室通过1/3 TEa的质量规范,70%以上的实验室通过基于生物学变异最低质量规范。σ水平分析中,σ度量值>6的实验室酶法组约43%,苦味酸法组约23%。结论肌酐不同检测系统实验室间变异情况酶法组优于苦味酸法组,多数检测系统的不精密度水平满足生物学变异的最低标准,酶法组的σ水平优于苦味酸法组。我国实验室肌酐的检测性能还有待于进一步提高。

Objective To study the performance of creatinine testing system in China. Methods A total of 5 different concentrations of quality control materials were distributed to 1 402 laboratories for the creatinine external quality assessment （EQA）, and the internal quality control（IQC） information for creatinine was collected in May 2011. Data were classified into different groups, according to 2 testing methods （Jaffe and enzymatic methods） and l 1 testing systems. The results of EQA were calculated, and without the outliers, the mean value （x）, standard deviation （s） and coefficient of variation （CV） were calculated. According to the 1/3 total allowable errors （ TEa ） and the quality standards based on biological variations, the system imprecision was determined. The means of difference from the EQA were used to evaluate bias for each laboratory, the accumulation CV was performed for the evaluation of imprecision, and then the sigma metric （cr） was calculated. Results In EQA results, the CV range for Jaffe method was 1.03%- 18.23% and for enzymatic method was 1.50%-8.08%. The lowest variation in Jaffe method group was in Beckman UniCel system, and the range of CV was 3. 13%-4.90%. The lowest variation in enzymatic method group was in HITACHI（Roche）system, and the range of CV was 1.50%-3.00%. In the IQC results, above 80% and above 70% laboratories can pass the 1/3 TEa and the minimum performance based on biological variations, respectively, and the a of 43% and 23% laboratories in enzymatic and Jaffe method groups can be 〉 6. Conclusions Between different laboratories, the variations of enzymatic method are better than those of the Jaffe method for creatinine testing system.Most testing system imprecision performance could match the minimum performance based on biological variations, and the （r of enzymatic method is better than that of Jaffe method. Performance of creatinine testing system needs to be improved in China.