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目的分析降钙素原(PCT)的检测结果在不同方法间的可比性。方法参照美国临床和实验室标准化研究所EP9-A3文件进行方法学比对和偏倚评估,用化学发光法和免疫透射比浊法分别测定40份标本的PCT水平,通过广义极端学生化偏差(ESD)法检验离群值点,选用最佳回归模型拟合回归方程,并计算医学决定水平处的偏倚。结果在散点图中未见异常值点,ESD法检验未发现离群值点;化学发光法和免疫透射比浊法检测结果相关性良好(r2>0.95);在PCT的医学决定水平处(0.50、2.00、10.00ng/mL),试验方法和参比方法的偏倚均小于可接受标准。结论免疫透射比浊法测定PCT的偏倚可接受,化学发光法和免疫透射比浊法测定PCT的结果具有可比性。
Objective To analyze the comparability of the results of procalcitonin (PCT) between different methods. Methods The methodological alignment and bias evaluation were performed according to EP9-A3 of the American Institute of Clinical and Laboratory Standards. The PCT levels of 40 specimens were determined by chemiluminescence and immunoturbidimetry respectively. The generalized extreme student-biased deviation (ESD) ) Method was used to test for outliers and the regression model was fitted using the best regression model and the bias at the level of medical decision was calculated. The results showed no abnormal values in the scatter plot and no outliers were detected by the ESD method. The results of chemiluminescence and immunoturbidimetry showed good correlation (r2> 0.95). At the medical decision level of PCT 0.50, 2.00, 10.00 ng / mL), both test method and reference method were less than acceptable bias. Conclusions The immunoturbidimetric method is suitable for the determination of PCT bias. The results of chemiluminescence and immunoturbidimetric assay for PCT are comparable.