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Open Access Article

International Journal of Clinical Research. 2022; 6: (1) ; 135-138 ; DOI: 10.12208/j.ijcr.20220009.

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

作者: 赵莛 *

广西维岭灿生物科技有限公司 广西南宁

*通讯作者: 赵莛,单位:广西维岭灿生物科技有限公司 广西南宁;

发布时间: 2022-02-28 总浏览量: 617

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。

关键词: 电化学发光法;免疫荧光法;降钙素原;性能

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.

Key words: Electrochemiluminescence; Immunofluorescence; Procalcitonin; Performance

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引用本文

赵莛, 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[J]. 国际临床研究杂志, 2022; 6: (1) : 135-138.