不同化学发光免疫分析系统检测亚临床甲状腺功能减退症血清促甲状腺激素的结果对比

摘要

目的 对疑似亚临床甲状腺功能减退症(简称亚甲减)患者血清样本应用4种化学发光免疫分析系统检测TSH,比较检测结果差异及对临床诊疗的影响. 方法 从上海交通大学附属第六人民医院检验科罗氏Cobas e601电化学发光分析系统检测平台收集103份血清样本(FT3、FT4正常,TSH 2.50~10.00 mU/L),其中90份血清TSH≥4.27 mU/L.采用4套不同厂家或型号的分析系统(Cobas e601、Immulite2000、Centaur XP、I2000)检测血清TSH.采用Wilcoxon符号秩检验及Spearman相关分析对检测结果进行差异比较和相关性分析.结果 4种血清TSH检测结果[M(P25,P75)]分别为5.20(4.73, 6.40)、2.95(2.59, 3.48)、3.30(2.94, 4.15)和4.10(3.43, 4.75) mU/L, 互有不同程度差异(z值:-8.78、-8.41、-7.64、-8.09、-8.50,均P<0.05),相关系数差异很大(r s为0.45~0.92).以各自的TSH截域值(超出正常参考范围上限的临界值)为参考,亚甲减的诊断符合率差异显著.结论 不同化学发光免疫分析系统检测在2.50~10.00 mU/L区间TSH的检测结果差异明显,以单次血清TSH检测值升高作为亚甲减的诊断依据存有技术不确定性.%Objective To evaluate the differences of serum TSH of suspicious subclinical hypothyroidism determined by four automatic biochemical analyzers and the impact on clinical diagnosis and treatment.Methods Taking results of Roche Cobas e601 laboratory test as a reference, 103 serum samples with TSH 2.50-10.00 mU/L(90 with TSH≥4.27 mU/L) and normal FT3, FT4 were selected.Four different automatic biochemical analyzers (Cobas e601, Immulite2000, Centaur XP, I2000) were used to measure TSH of the serum samples at the same time.Wilcoxon signed rank test, Spearman correlation analysis were used for data analysis.Results TSH (M(P25, P75)) measured by 4 methods were 5.20(4.73, 6.40), 2.95(2.59, 3.48), 3.30(2.94, 4.15) and 4.10(3.43, 4.75) mU/L, which varied significantly from one assay to another (z values:-8.78,-8.41,-7.64,-8.09,-8.50, all P<0.05).The correlations between methods were of great differences (rs ranged from 0.45 to 0.92).Significant differences existed in each other for subclinical hypothyroidism diagnosis based on TSH cutoff respectively.Conclusion Results from different automatic immunoassay analyzers in patients with TSH of 2.50-10.00 mU/L varied widely, hence, it is indeterminate to diagnose subclinical hypothyroidism only relies on a single serum TSH test.