3种化学发光检测系统检测CA19-9的一致性评价  

An Evaluation of the Consistency Among Three Chemiluminescence Detection Systems for Detecting CA19-9

作　　者：郑芸[1] 李清茹[1] ZHENG Yun;LI Qingru(Department of Nuclear Medicine,the First Affiliated Hospital of Suzhou University,Suzhou 215006,China)

机构地区：[1]苏州大学附属第一医院核医学科,江苏苏州215006

出　　处：《标记免疫分析与临床》2024年第5期936-940,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的评价新产业、罗氏、雅培发光系统检测CA19-9指标的结果一致性。方法确认核医学科近期雅培CA19-9检测样本并保存,分别在新产业及罗氏检测系统复测,依据临床诊断信息分组,通过成对样本秩和检验、Passing-Bablok回归性分析及Kappa分析比较该指标在各厂家检测系统的血清学表达差异。通过ROC曲线比较分析各厂家指标在诊断恶性肿瘤的效能。结果秩和检验表明,3种检测系统检测CA19-9,成对数据差异性显著。相关性及Passing-Bablok分析,罗氏与新产业相关系数R^(2)为0.931,Y=0.8875X+1.3765,两检测系统结果线性度无明显偏差;罗氏与雅培相关系数R^(2)为0.5818,Y=1.7178X-6.4599,两检测系统结果线性度有明显偏差;新产业与雅培相关系数R^(2)为0.5195,Y=0.4690X+5.5883,两检测系统结果线性度有明显偏差。Kappa分析中,罗氏与新产业组Kappa值为0.864,一致性较好;罗氏与雅培组Kappa值为0.714,一致性一般;新产业与雅培组Kappa值为0.650,一致性一般。针对恶性肿瘤的ROC分析,罗氏CA19-9曲线下面积为0.688;新产业CA19-9曲线下面积为0.679;雅培CA19-9曲线下面积为0.651。在检测恶性肿瘤中,罗氏CA19-9灵敏度为73.91%,特异性为59.81%,总符合度为65.34%;新产业CA19-9灵敏度为65.22%,特异性为65.42%,总符合度为65.34%;雅培CA19-9灵敏度为63.77%,特异性为52.33%,总符合度为56.82%。结论罗氏与新产业比对结果线性度无明显偏差,一致性较高,两种检测结果的互换性较为理想;对于恶性肿瘤的诊断,两厂家检测系统对CA19-9诊断效能均为良好;单纯依据CA19-9结果做恶性肿瘤的诊断,3种诊断效能均不理想。Objective To evaluate the consistency of the detection results of CA19-9 indicators by the New Industry,Roche,and Abbott luminescent systems.Methods We collected and confirmed recent Abbott CA19-9 test samples from the Department of Nuclear Medicine and saved them for retesting in the New Industry and Roche testing systems.Samples were grouped based on clinical diagnostic information.We compared the serological expressions of CA19-9 in the testing systems of various manufacturers through paired sample rank sum test,Passing Bablock regression analysis,and Kappa analysis.We then compared and analyzed the efficacy of various manufacturer indicators in diagnosing malignant tumors through ROC curves.Results The rank sum test showed that the three detection systems all detected CA19-9,and there was a significant difference in paired data.Correlation and Passing Bablock analysis showed that the correlation coefficient R^(2)between Roche and New Industries was 0.931,Y=0.8875 X+1.3765,and there was no significant deviation in the linearity of the results of these two detection systems;The correlation coefficient R^(2)between Roche and Abbott was 0.5818,Y=1.7178 X-6.4599,and there was a significant deviation in the linearity of the results of these two detection systems;The correlation coefficient R^(2)between the New Industry and Abbott was 0.5195,Y=0.4690 X+5.5883,and there was a significant deviation in the linearity of the results of these two testing systems.The Kappa value of Roche and the New Industry group was 0.864,indicating a good consistency;The Kappa value of Roche and Abbott groups was 0.714,with a moderate consistency;The Kappa value of the New Industry and Abbott’s group was 0.650,with an average consistency.AUC of the Roche for CA19-9 was 0.688,while AUC of the New Industry was 0.679 and AUC of the Abbott CA19-9 was 0.651.In the detection of malignant tumors,the sensitivity of Roche for CA19-9 was 73.91%,the specificity was 59.81%,and the overall conformity was 65.34%;The sensitivity of the New Industry

关 键 词：CA19-9 化学发光 实验室评价 

分 类 号：R-331[医药卫生]