前列腺相关标志物在不同检测系统中结果的相关性分析  

The Correlation Analysis of Prostate Related Markers inDifferent Detection Systems

作　　者：王修全[1] 邱顺华[1] 童玲[1] 张潜英[1] WANG Xiuquan;QIU Shunhua;TONG Ling;ZHANG Qianying(Department of Medical Laboratory,the Third People’s Hospital of Zigong,Zigong 643020,China)

机构地区：[1]自贡市第三人民医院医学检验科,四川自贡643020

出　　处：《标记免疫分析与临床》2023年第5期863-866,共4页Labeled Immunoassays and Clinical Medicine

基　　金：老年前列腺增生的综合防控技术研究与精准风险评估和个体化防治措施应用示范(编号:2021YFC2009300)。

摘　　要：目的探讨前列腺相关标志物总前列腺特异性抗原(total prostate specific antigen,tPSA)和游离前列腺特异性抗原(free prostate specific antigen,fPSA)在全自动生化分析系统贝克曼(AU5811)、全自动化学发光分析系统贝克曼(DXI800)和迈瑞CL-2000i中检测结果的相关性。方法AU5811采用胶乳免疫比浊法,DXI800、CL-2000i采用磁微粒化学发光法,检测不同浓度tPSA和fPSA的结果,依据CNAS-GL037临床化学定量检验程序性能验证指南要求,按照WS/T492-2016规定的方法,对用胶乳免疫比浊法在AU5811上检测tPSA和fPSA的结果进行可比性验证,选择5个水平室间质控品202211~202215,每一样本重复检测3次,计算均值和偏倚,用试剂盒自带2水平质控做精密度评价。各系统分别测定253例确诊前列腺增生患者的血液tPSA和fPSA水平,评价AU5811检测系统与DXI800、CL-2000i检测系统结果的相关性。结果AU5811检测tPSA和fPSA可比性验证符合要求,tPSA 5水平的偏倚分别为-8.25%、4.78%、3.55%、-5.88%、-3.46%,fPSA 5水平的偏倚分别为-10.00%、-8.11%、3.72%、10.59%、-7.04%;精密度验证tPSA水平1批内CV为5.43%、总CV为5.42%,水平2批内CV为3.16%、总CV为3.35%;fPSA水平1批内CV为8.91%、总CV为8.94%,水平2批内CV为6.82%、总CV为6.99%;其CV值均低于试剂说明书规定CV(10%)。253例确诊前列腺增生患者的血液tPSA和fPSA在AU5811检测结果分别与DXI800和CL-2000i上检测结果比较,其相关系数tPSA为0.977、0.945,fPSA相关系数为0.951、0.918,在0.01水平(双侧)上显著相关。结论贝克曼AU5811系统检测tPSA和fPSA可比性验证符合要求,批内精密度与总精密度均小于试剂盒说明书要求,验证通过,AU5811系统与DXI800、CL-2000i检测tPSA和fPSA结果比较具有较好的相关性。Objective To explore the correlation between the detection results of prostate-related markers total prostate-specific antigen(tPSA)and free prostate-specific antigen(fPSA)in automatic biochemical analysis system Beckman(AU5811),automatic chemiluminescence analysis system Beckman(DXI800)and Mindray(CL-2000i).Methods The results of tPSA and fPSA at different concentrations were detected by latex immunoturbidimetry for AU5811 and magnetic particle chemiluminescence for DXI800 and CL-2000i.According to the method stipulated by WS/T492-2016,the results of tPSA and fPSA detected by latex immunoturbidimetry on AU5811 were validated for comparability.Five horizontal quality control products 202211-202215 were selected,each of which was tested three times in duplicate,and the mean value and bias were calculated.Precision evaluation was performed with the 2-level quality control provided with the kit.Levels of tPSA and fPSA in 253 patients with prostatic hyperplasia were measured by each system,and the correlation between AU5811 detection system and DXI800 and CL-2000I detection system was evaluated.Results The comparability of tPSA and fPSA detected by AU5811 met the requirements.The bias of tPSA 5 level were-8.25%,4.78%,3.55%,-5.88%,-3.46%,and the bias of fPSA 5 level were-10.00%,-8.11%,3.72%,10.59%,-7.04%,respectively.The CV of the first batch of tPSA was 5.43%and the total CV was 5.42%,and the CV of the second batch was 3.16%and the total CV was 3.35%.The CV of fPSA level in the first batch was 8.91%and the total CV was 8.94%,and the CV of fPSA level in the second batch was 6.82%and the total CV was 6.99%,all of which were lower than the CV specified in the reagent instruction(10%).The results of tPSA and fPSA were compared with those of DXI800 and CL-2000i on AU5811,respectively.The correlation coefficients of tPSA and fPSA were 0.977 and 0.945,0.951 and 0.918,respectively.Significant correlation was found at 0.01 level(two sides).Conclusion The comparability verification of the Beckman AU5811 system for detecting tP

关 键 词：前列腺标志物 TPSA FPSA 可比性 相关性 

分 类 号：R446.1[医药卫生—诊断学]