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电化学发光法和直接化学发光法测定12项肿瘤标志物指标的相关性和一致性评价

马淼 刘杰 马瑞敏 李萍燕 鲁静 许惠文 于丹葳 张国军

中国医学装备2024,Vol.21Issue(5):20-25,6.
中国医学装备2024,Vol.21Issue(5):20-25,6.DOI:10.3969/j.issn.1672-8270.2024.05.004

电化学发光法和直接化学发光法测定12项肿瘤标志物指标的相关性和一致性评价

Correlation and consistency evaluation between electrochemiluminescence and direct chemiluminescence in detecting 12 tumor markers

马淼 1刘杰 1马瑞敏 1李萍燕 1鲁静 1许惠文 1于丹葳 1张国军1

作者信息

  • 1. 首都医科大学附属北京天坛医院实验诊断中心 北京市免疫试剂临床工程技术研究中心 国家药监局体外诊断质量控制重点实验室 北京 100070
  • 折叠

摘要

Abstract

Objective:To assess the correlation and consistency of electrochemiluminescence and direct chemiluminescence in detecting 12 tumor markers.Methods:A total of 2426 serum specimens were selected from the physical examination in Beijing Tiantan Hospital,Capital Medical University from March to August 2023.These specimens included 446 cases for alpha fetoprotein(AFP),284 cases for carcinoembryonic antigen(CEA),289 cases for carbohydrate antigen 72-4(CA72-4),87 cases for carbohydrate antigen 19-9(CA19-9),205 cases for carbohydrate antigen 125(CA-125),216 cases for carbohydrate antigen 15-3(CA 15-3),292 cases for total prostate specific antigen(TPSA),292 cases for free prostate specific antigen(FPSA),84 cases for serum cytokeratin 19 fragment(Cyfra21-1),84 cases for neuron specific enolase(NSE),84 cases for squamous cell carcinoma associated antigen(SCC)and 63 cases for pro-gastrin-releasing peptide(PROGrp).The electrochemiluminescence and direct chemiluminescence methods were respectively used to detect the above 12 indexes,and then,the correlation and consistency between the two detection methods were analyzed.Results:The results of Pearson and Spearman correlation analysis showed that there were significantly positive correlations between electrochemiluminescence and direct chemiluminescence methods in detecting 12 tumor indexes(AFP,CEA,CA72-4,CA19-9,CA125,CA15-3,TPSA,FPSA,Cyfra21-1,NSE,SCC and PROGrp)(r=0.971,0.934,0.945,0.975,0.900,0.948,0.994,0.984,0.982,0.828,0.879,0.922,P<0.05),respectively.The total coincidence rates between the two methods were respectively 98.21%,98.24%,98.27%,98.85%,97.07%,99.54%,99.66%,99.32%,92.86%,92.86%,95.24%and 96.83%.There were consistencies between electrochemiluminescence and direct chemiluminescence methods for 10 indexes excepted CA15-3 and NSE that could not calculate Kappa values due to data reasons(Kappa=0.848,0.728,0.930,0.794,0.485,0.887,0.664,0.540,0.477,0.652,P<0.05),respectively.Conclusion:In the detections of electrochemiluminescence and direct chemiluminescence methods for tumor indexes,there are favorable correlations and consistencies between them in detecting AFP,CA72-4,CA19-9 and TPSA,and there are favorable correlations between them in detecting CEA,CA125,FPSA,Cyfra21-1,SCC and PROGrp but the consistencies between them are average in detecting these indexes,and there are favorable correlations between them in detecting CA15-3 and NSE.Clinical detection should pay attention to there may be differences in the results between different detection methods when the detection is conducted in reference laboratory.

关键词

肿瘤标志物/电化学发光/直接化学发光/相关性/一致性

Key words

Tumor mark/Electrochemiluminescence/Direct chemiluminescence/Correlation/Consistency

分类

医药卫生

引用本文复制引用

马淼,刘杰,马瑞敏,李萍燕,鲁静,许惠文,于丹葳,张国军..电化学发光法和直接化学发光法测定12项肿瘤标志物指标的相关性和一致性评价[J].中国医学装备,2024,21(5):20-25,6.

基金项目

北京市高层次公共卫生技术人才培养计划(2022-2-013) Talent Development Plan for High-level Public Health Technical Personnel Project(2022-2-013) (2022-2-013)

中国医学装备

OACSTPCD

1672-8270

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