罗氏Cobas8000 e801电化学发光免疫分析仪对促甲状腺激素的检出效能分析  

Detection Efficiency of Roche Cobas8000 e801 Electrochemiluminescence Immunoassay for Thyroid Stimulating Hormone

作　　者：周珣 魏欣宇 冯慧芬 骆跃兴 ZHOU Xun;WEI Xin-yu;FENG Hui-fen;LUO Yue-xing(Laboratory Department,Nanping Second Hospital,Fujian Nanping 354399;Laboratory Department,Central Health Center of Shuiji Town,Jianyang District,Nanping City,Fujian Nanping 354207)

机构地区：[1]南平市第二医院检验科,福建南平354399 [2]南平市建阳区水吉镇中心卫生院检验科,福建南平354207

出　　处：《中国医疗器械信息》2025年第6期87-89,共3页China Medical Device Information

摘　　要：目的:分析罗氏Cobas8000e801电化学发光免疫分析仪用于促甲状腺激素的检出效能。方法:选择在2022年1月~2023年7月接受诊断的108例受检者作为此次的研究对象,以健康受检者54例为对照组,54例为甲状腺功能减退组,均使用罗氏Cobas8000 e801电化学发光免疫分析仪进行检测,分析两组的促甲状腺激素水平和诊断效能。结果:和对照组相比,甲状腺功能减退组的促甲状腺激素水平明显更高,组间对比有统计学意义(P<0.05),在仪器检测性能分析中,在稳定性检测中,仪器在4h和6h的相对偏倚分别为6%、-4%,稳定性检测符合厂家的误差范围。线性范围结果在0.09~84左右,正确度检测中,样本校准的结果和靶值之间的偏差在-2.7%~3.6%。结论:罗氏Cobas8000 e801有比较理想的稳定性和检测准确率,临床诊断的主要性能和厂商所规定的性能具有较高的一致性,可以满足临床的诊断需求,且操作简单,适应范围广。Objective:To analyze the efficacy of Roche Cobas8000 e801 electrochemiluminescence immunoassay for the detection of thyroid stimulating hormone.Methods:108 patients diagnosed from January 2022 to July 2023 were selected as the study objects,54 healthy subjects were selected as the control group,and 54 were hypothyroidism.All patients were detected by Roche Cobas8000 e801 electrochemiluminescence immunoassay.The levels and diagnostic efficacy of thyrotropin were analyzed.Results:Compared with the control group,the level of thyrotropin in the hypothyroidism group was significantly higher,and the comparison between groups was statistically significant(P<0.05).In the analysis of instrument performance,the relative bias of the instrument at 4h and 6h was 6%and-4%,respectively,in the stability test,the stability test was in line with the manufacturer’s error range.The linear range is about 0.09-84,and the deviation between the sample calibration result and the target value is between-2.7%-3.6%in the accuracy test.Conclusion:Roche Cobas8000 e801 has a relatively ideal stability and detection accuracy,the main performance of clinical diagnosis and the performance specified by the manufacturer has a high consistency,can meet the needs of clinical diagnosis,and simple operation,wide range of adaptation.

关 键 词：罗氏Cobas8000e801 电化学发光免疫分析仪 促甲状腺激素 诊断 

分 类 号：R446.1[医药卫生—诊断学]