临床检验定量免疫分析检测项目的质量控制设计程序

摘要

Objective To study the internal quality control(IQC)designing procedure of the quantitative immunoassay testing i-tem to provide the most suitable IQC rule for the clinical laboratory immunoassay.Methods 3 quantitative detection items of thy-roxine,cortisol and thyroid stimulating hormone were taken for examples.The coefficient of variation(CV)of the method was ob-tained by the repeatability test for evaluating the methodological imprecision.Inaccuracy(bias)was obtained by the methods com-parison.The accuracy of the method was evaluated.Then the most suitable IQC rule for each quantitative detection item was select-ed by plotting the location of the operating point on the normalized operational process specifications(OPSpecs)chart according to CV and bias.Results Two multirule methods of 1 3s/(2of3)2s/R4s/3 1s/6 x and 1 3s/(2of3)2s/R4s/3 1s were identified when the oper-ating point was plotted on the normalized OPSpecs chart for N =6 and 90% analytical quality assurance(AQA)at the thyroxine de-cisive level of 0.064 4 mmol/L.When the cortisol decisive level was 0.735 μmol/L,the normalized OPSpecs chart for N =3 with 90%AQA showed the three solutions of 1 3s/(2of3)2s/R4s/3 1s ,1 2 .5s ,and 1 3s/(2of3)2s/R4s as for thyroid stimulating hormone,3 1s/2 2s/R4s/41s multirole procedure was the best choice for N =4,50%AQA at the upper control level,and the N =2 chart with 50%AQA showed a multirole procedure with 1 3s/2 2s/R4s at the lower control level.Conclusion The suitable internal quality control de-signing procedure of the quantitative immunoassay testing item can be selected by using the OPSpecs chart.%目的：研究定量免疫分析检测项目的室内质量控制设计程序，为临床实验室免疫分析提供最合适的室内质量控制规则。方法以甲状腺素、皮质醇和促甲状腺激素3个定量检测项目为例，通过重复性试验得到方法的变异系数，作为方法不精密度的评估，再通过方法比对得到偏倚，评估方法的正确度，然后根据变异系数和偏倚在操作过程规范（OPSpecs）图中标出操作点的位置，选择各定量免疫分析检测项目最合适的质量控制规则。结果当甲状腺素决定水平为0．0644 mmol/L 时，N ＝6，分析质量保证（AQA）为90％的操作过程规范（OPSpecs）图提示13s/（2of3）2s/R4s/31s/6 x 和13s/（2of3）2s/R4s/31s 两种多规则方法。当皮质醇的决定水平为0．735μmol/L，N ＝3，AQA 为90％时，可以采用13s/（2of3）2s/R4s/31s 、12．5s 或13s/（2of3）2s/R4s 3种方法。当促甲状腺激素为高浓度水平，N ＝4，AQA 为50％时，最好使用31s/22s/R4s/41s 多规则；当为低浓度水平，N ＝2，AQA 为50％时，可以使用13s/22s/R4s 规则。结论使用操作过程规范图可以为定量免疫分析检测项目选择合适的室内质量控制设计程序。