Quality control designing procedure of quantitative immunoassay testing item for clinical laboratory / 国际检验医学杂志

ABSTRACT

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.