临床检验定量免疫分析检测项目的质量控制设计程序
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摘要
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0.064 4mmol/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/6x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/R4s3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。
Objective To study the internal quality control(IQC)designing procedure of the quantitative immunoassay testing item to provide the most suitable IQC rule for the clinical laboratory immunoassay.Methods 3quantitative detection items of thyroxine,cortisol and thyroid stimulating hormone were taken for examples.The coefficient of variation(CV)of the method was obtained by the repeatability test for evaluating the methodological imprecision.Inaccuracy(bias)was obtained by the methods comparison.The accuracy of the method was evaluated.Then the most suitable IQC rule for each quantitative detection item was selected by plotting the location of the operating point on the normalized operational process specifications(OPSpecs)chart according to CVand bias.Results Two multirule methods of 13s/(2of3)2s/R4s/31s/6xand 13s/(2of3)2s/R4s/31 swere identified when the operating point was plotted on the normalized OPSpecs chart for N=6and 90%analytical quality assurance(AQA)at the thyroxine decisive level of 0.064 4mmol/L.When the cortisol decisive level was 0.735μmol/L,the normalized OPSpecs chart for N=3with90%AQA showed the three solutions of 13s/(2of3)2s/R4s/31 s,12.5s,and 13s/(2of3)2s/R4 sas for thyroid stimulating hormone,31s/22s/R4s/41 smultirole procedure was the best choice for N=4,50%AQA at the upper control level,and the N=2chart with 50%AQA showed a multirole procedure with 13s/22s/R4 sat the lower control level.Conclusion The suitable internal quality control designing procedure of the quantitative immunoassay testing item can be selected by using the OPSpecs chart.
Objective To study the internal quality control(IQC)designing procedure of the quantitative immunoassay testing item to provide the most suitable IQC rule for the clinical laboratory immunoassay.Methods 3quantitative detection items of thyroxine,cortisol and thyroid stimulating hormone were taken for examples.The coefficient of variation(CV)of the method was obtained by the repeatability test for evaluating the methodological imprecision.Inaccuracy(bias)was obtained by the methods comparison.The accuracy of the method was evaluated.Then the most suitable IQC rule for each quantitative detection item was selected by plotting the location of the operating point on the normalized operational process specifications(OPSpecs)chart according to CVand bias.Results Two multirule methods of 13s/(2of3)2s/R4s/31s/6xand 13s/(2of3)2s/R4s/31 swere identified when the operating point was plotted on the normalized OPSpecs chart for N=6and 90%analytical quality assurance(AQA)at the thyroxine decisive level of 0.064 4mmol/L.When the cortisol decisive level was 0.735μmol/L,the normalized OPSpecs chart for N=3with90%AQA showed the three solutions of 13s/(2of3)2s/R4s/31 s,12.5s,and 13s/(2of3)2s/R4 sas for thyroid stimulating hormone,31s/22s/R4s/41 smultirole procedure was the best choice for N=4,50%AQA at the upper control level,and the N=2chart with 50%AQA showed a multirole procedure with 13s/22s/R4 sat the lower control level.Conclusion The suitable internal quality control designing procedure of the quantitative immunoassay testing item can be selected by using the OPSpecs chart.
引文
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[2]Westgard JO,Stein B,Westgard SA,et al.QC Validator 2.0:a computer program for automatic selection of statistical QC procedures for applications in healthcare laboratories.Comput Methods Programs Biomed,1997,53(3):175-186.
[3]Westgard JO,Stein B.Automated selection of statistical qualitycontrol procedures to assure meeting clinical or analytical quality requirements[J].Clin Chem,1997,43(1):400-403.
[4]Mugan K,Carlson IH,Westgard JO.Planning QC procedures for immunoassays[J].J Clin Immunoassay,1994,17(1):216-222.
[5]Carey RN.Tips for managing the quality of immunoassays[EB/OL].[2013-8-22].http://www.westgard.com/guest4.htm.
[6]王治国.临床检验质量控制技术[M].北京:人民卫生出版社,2008.