国产全自动免疫发光分析仪检测胃癌肿瘤标志物与进口设备检测结果的比较分析  

Comparative Analysis of Detection Results of Gastric Cancer Tumor Markers Using Domestically Produced Fully Automatic Immunoluminescence Analyzer and Imported Equipment

作　　者：徐进 孙斗智 XU Jin;SUN Dou-zhi(Laboratory Department of Langxi County People’s Hospital,Anhui Xuancheng 242199)

机构地区：[1]郎溪县人民医院检验科,安徽宣城242199

出　　处：《中国医疗器械信息》2024年第5期90-92,共3页China Medical Device Information

摘　　要：目的:分析国产全自动免疫发光分析仪检测胃癌肿瘤标志物癌胚抗原(CEA)、糖类抗原19-9(CA19-9)和糖类抗原72-4(CA72-4)指标与进口设备检测结果的临床符合度。方法:将2020年1月~2022年12月本院收治的58例胃部恶性肿瘤疾病患者为本次研究的观察组,同期选取58例来本院参加健康体检或经临床诊断为胃部良性病变的人群为本次研究的对照组。分别用国产全自动免疫发光分析仪和进口化学发光分析仪对纳入的研究对象进行血清学胃癌肿瘤标志物CEA、CA19-9和CA72-4指标检测。对比分析国产和进口设备观察指标检测结果的符合度;对比分析国产与进口设备观察指标鉴别诊断胃癌的临床诊断效率;利用Pearson相关对二种设备观察指标检测结果的相关性线性回归分析。结果:国产与进口设备CEA、CA19-9和CA72-4指标的整体符合度分别为93.97%、92.24%和97.41%;国产设备检测CEA、CA19-9和CA72-4指标结果鉴别诊断胃癌的诊断效率与进口设备检测结果均无显著性差异(P>0.05);线性回归结果表明,二种设备对CEA(r=0.990)、CA19-9(r=0.983)和CA72-4(r=0.996)指标的检测结果具有较强的相关性。结论:国产全自动免疫发光分析仪检测胃癌肿瘤标志物CEA、CA19-9和CA72-4与进口设备检测结果符合度较好,可用于替代进口设备对胃癌高风险人群的辅助诊断和早期筛查,有利于节约医保资金和降低患者诊疗费用。Objective:Analyze the clinical consistency between the detection of gastric cancer tumor markers carcinoembryonic antigen(CEA),carbohydrate antigen 19-9(CA19-9),and carbohydrate antigen 72-4(CA72-4)using a domestically produced fully automated immunoluminescence analyzer and the detection results of imported equipment.Methods:58 patients with gastric malignant tumors admitted to our hospital between January 2020 and December 2022 were selected as the observation group for this study,while 58 individuals who participated in health examinations or were clinically diagnosed with benign gastric lesions were selected as the control group for this study.Serological detection of gastric cancer tumor markers CEA,CA19-9,and CA72-4 was performed on the included research subjects using domestically produced fully automated immunoluminescence analyzers and imported chemiluminescence analyzers,respectively.Compare and analyze the conformity of the observation index test results between domestic and imported equipment;Comparative analysis of the clinical diagnostic efficiency of differential diagnosis of gastric cancer using observation indicators between domestic and imported equipment;Linear regression analysis of the correlation between observation indicators and detection results of two devices using Pearson correlation.Results:The overall compliance of CEA,CA19-9,and CA72-4 indicators for domestic and imported equipment is 93.97%,92.24%,and 97.41%,respectively;There was no significant difference(P>0.05)in the diagnostic efficiency of differential diagnosis of gastric cancer between domestic equipment testing CEA,CA19-9,and CA72-4 indicators and imported equipment testing results;The linear regression results indicate that the two devices have a strong correlation with the detection results of CEA(r=0.990),CA19-9(r=0.983),and CA72-4(r=0.996)indicators.Conclusion:The domestically produced fully automatic immunoluminescence analyzer detects gastric cancer tumor markers CEA,CA19-9,and CA72-4 with good consistency with the det

关 键 词：国产全自动免疫发光分析仪 胃癌肿瘤标志物 进口设备 对比分析 

分 类 号：TH776[机械工程—仪器科学与技术]