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罗氏602与雅培iSR2000全自动生化分析仪部分肿瘤项目比对分析

Evaluation of the Comparability of Tumor Test Indicators by Roche 602 and Abbott iSR2000 for Automatic Biochemical Analysis

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【作者】 廖思钦; 廖美艳; 池青; 黄光秀; 邹文毕;

【Author】 LIAO Si-qin;LIAO Mei-yan;CHI Qing;HUANG Guang-xiu;ZOU Wen-bi;Departmentof Clinical Lab, Foshan Sanshui District People’s Hospital;

【通讯作者】 邹文毕;

【机构】 佛山市三水区人民医院检验科;

【摘要】 目的:探讨本科室两台不同全自动生化分析仪对癌胚抗原(CEA)、甲胎蛋白(AFP)检测结果的可比性和一致性。方法:随机收集60例患者血清样本,分别在罗氏602和雅培iSR2000全自动生化分析仪上进行检测,并对结果进行相关性分析,求出回归方程和相关系数,最后采用Bland-Altman(BA)分析法对两台仪器的一致性进行评价。结果:两台全自动生化分析仪各项目的变异系数CV均≤3.5%,稳定性较好,CEA和AFP的结果相关性良好,r~2分别为0.982和0.997;采用Bland-Altman法对两种仪器检测结果的一致性进行分析,CEA和AFP的一致性界限内的点为96.67%和95.00%。结论:两台仪器检测结果的一致性良好,两台仪器的结果可以通用。实验室内的生化仪器之间的比对是保证结果可比性的关键因素。

【Abstract】 Objective: To explore the comparability and consistency of the carcinoembryonic antigen(CEA), and alpha fetoprotein(AFP) results of two different automatic biochemical analyzers. Methods: 60 serum samples from patients were systematically collected and subjected to testing on the Roche 602 and Abbott iSR2000 fully automated biochemical analyzers. Subsequent correlation analysis was conducted to determine the regression equation and correlation coefficient. Finally, the concordance between the two instruments was evaluated utilizing the Bland-Altman(BA) analysis method. Results: The coefficient of variation(CV) of each item of the two fully automatic biochemical analyzers were ≤ 3.5%, indicating good stability. The correlation between CEA and AFP results was good, with r~2 values of 0.982 and 0.997, respectively;The consistency of the detection results of the two instruments was analyzed using the Bland-Altman method, and the points within the consistency limits of CEA and AFP were 96.67% and 95.00%, respectively. Conclusion: The consistency of the test results of the two instruments is good, and the results of the two instruments can be used universally. Comparison between biochemical instruments is a key factor in ensuring comparability of results in the laboratory.

【基金】 2022年佛山市科学技术局医学科研课题(课题名称:联合检测血清维生素D和同型半胱氨酸对多囊卵巢综合征患者的早期诊断,课题编号:2220001004187)
  • 【文献出处】 中国医疗器械信息 ,China Medical Device Information , 编辑部邮箱 ,2024年12期
  • 【分类号】R446.1
  • 【下载频次】9
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