Performance evaluation of electrochemiluminescence and immunofluorescence in the detection of procalcitonin
电化学发光法及免疫荧光法在降钙素原检测中的性能评估

摘要

目的 评估电化学发光法及免疫荧光法在降钙素原检测中的性能。方法 收集血清样本255份，分别采用电化学发光法、免疫荧光法进行检测，以免疫荧光法作为参考系统，对电化学发光法分别进行精密度、正确性、相关性以及一致性分析。结果 电化学免疫荧光分析仪检测PCT精密度的变异系数<10%,与厂家的声明具有一致性。电化学免疫荧光分析仪检测结果的均值为16.34ng/ml，免疫荧光检测仪检测结果的均值为15.55ng/ml，百分偏倚为-11.05%,百分偏倚的标准差为14.87%。百分偏倚置信区间为-1.53%～-20.57%，覆盖了声明的±15%的百分偏倚。电化学发光法以及免疫荧光法检测总体及各个区间内的数据在P<0.01水平上明显相关（y=0.861x+0372，R2=0.960）。采用Kappa检验分析电化学发光法与免疫荧光法检测数据之间的一致性，Kappa值为0.92。结论 电化学免疫荧光分析仪精密度良好，与免疫荧光检测系统偏倚性较小，相关性以及一致性均良好，临床上可以根据具体情况选取适宜的检测方法。

Abstract

Objective To evaluate the performance of electrochemiluminescence and immunofluorescence in the detection of procalcitonin.
Methods: 255 serum samples were collected and detected by electrochemiluminescence method and immunofluorescence method respectively. Using immunofluorescence method as a reference system, the precision, correctness, correlation and consistency of electrochemiluminescence method were analyzed respectively.
Results: The coefficient of variation of the precision of PCT detected by electrochemical immunofluorescence analyzer was less than 10%, which was consistent with the manufacturer's statement. The mean value of electrochemical immunofluorescence analyzer was 16.34ng/ml, the mean value of immunofluorescence analyzer was 15.55ng/ml, the percentage bias was -11.05%, and the standard deviation of the percentage bias was 14.87%. The percent bias confidence interval ranged from -1.53% to -20.57%, covering the stated percent bias of ±15%. The data detected by electrochemiluminescence and immunofluorescence methods were significantly correlated at the level of P<0.01 (y=0.861x+0372, R2=0.960). The Kappa test was used to analyze the consistency between the data detected by electrochemiluminescence and immunofluorescence, and the Kappa value was 0.92.
Conclusion  : Electrochemical immunofluorescence analyzer has good precision, less bias with immunofluorescence detection system, and good correlation and consistency. In clinical practice, appropriate detection methods can be selected according to specific conditions.