同型半胱氨酸不同检测方法结果分析  

Result analysis of various detection methods for homocysteine

作　　者：赵彦[1] 康凤凤[1] 王薇[1] 何法霖[1] 钟堃[1] 王治国[1] 

机构地区：[1]北京医院卫生部临床检验中心,北京100730

出　　处：《检验医学》2015年第3期284-286,共3页Laboratory Medicine

基　　金：北京市自然科学基金资助项目(7143182)

摘　　要：目的评价并分析同型半胱氨酸（Hcy）项目不同检测方法的结果。方法采用卫生部临床检验中心（NCCL）的室内质量控制（IQC）监测系统调查分析全国110家实验室Hcy检测项目的不精密度水平[即变异系数（CV）]。再利用NCCL基于Web的室间质量评价（EQA）系统评估2012年全国110家实验室Hcy检测的偏倚（Bias）。引入我国目前的EQA评价标准（TEa=20%）进行评价,并通过公式西格玛（σ）=（TEa-Bias）/CV计算项目的σ度量值。同时评价各方法组实验室的及格率和实验室间CV。结果从σ水平、实验室间的不精密度水平以及EQA及格率三方面对Hcy不同检测方法的结果进行分析,化学发光法σ〉6、3〈σ≤6、0〈σ≤3、σ≤0的比例分别为0%、7.69%、30.77%、61.54%,免疫比浊法分别为9.09%、0%、63.64%、27.27%,循环酶法分别为11.63%、31.40%、47.67%、9.30%。化学发光法、免疫比浊法、循环酶法5个批号质控品的实验室间CV分别为33.66%-43.77%、19.54%-25.24%、10.46%-14.21%,及格率分别为53.3%、53.3%-80.0%、85.9%-92.3%。结论我国Hcy的检测水平还有待提高。Objective To evaluate the results of various detection methods for homocysteine（Hcy）.Methods The internal quality control（IQC） information of 110 laboratories from National Center for Clinical Laboratory（NCCL）was collected.The imprecision [coefficient of variation（CV） ] of Hcy was analyzed.Bias was estimated according to various detection methods in NCCL External Quality Assessment（EQA） in 2012 through online EQA platform.With current evaluation criteria for EQA（TEa = 20%）,sigma（σ） value of each laboratory was calculated as the formula： σ=（TEa-bias） / CV.Furthermore,the passing rates and inter-laboratory CV for each group were evaluated.Results The proportions of σ 〉6,3〈 σ ≤6,0 〈σ ≤3 and σ ≤0 by chemiluminescence,immunoturbidimetry and enzymatic cycling were 0%,7.69%,30.77%,61.54%; 9.09%,0%,63.64%,27.27% and 11.63%,31.40% 47.67%,9.30%,respectively.The inter-laboratory CV by the 3 methods for 5-run quality control materials were 33.66%-43.77%,19.54%-25.24% and 10.46%-14.21%,and the passing rates were 53.3%,53.3%-80.0% and 85.9%-92.3%.Conclusions Laboratories in China need further efforts to improve the performance of Hcy detection.

关 键 词：同型半胱氨酸 六西格玛 西格玛度量 不精密度 偏倚 

分 类 号：R446.1[医药卫生—诊断学]