通过电化学发光免疫分析对促甲状腺激素和甲状腺激素进行分析及临床评估。

Analytical and clinical evaluation of TSH and thyroid hormones by electrochemiluminescent immunoassays.

作者信息

Sánchez-Carbayo M, Mauri M, Alfayate R, Miralles C, Soria F

机构信息

Laboratorio de Hormonas, Servicio de Análisis Clínicos, Hospital General Universitario de Alicante, Spain.

出版信息

Clin Biochem. 1999 Aug;32(6):395-403. doi: 10.1016/s0009-9120(99)00032-6.

DOI:10.1016/s0009-9120(99)00032-6

PMID:10667473

Abstract

OBJECTIVES

To perform an analytical evaluation of the new electrochemiluminescent immunoassays (ECLIA) for TSH, FT4, and T3 in the Elecsys 2010 immunoassay system. To assess the clinical classification of patients under suspicion of thyroid disease based on these laboratory assays.

MATERIALS AND METHODS

The analytical evaluation included the performance of minimum detectable concentrations, within-assay and inter-assay precision for the three analytes, functional sensitivity and linearity studies for TSH, and method comparison with the previous methods of RIA for FT4 and T3, and IRMA for TSH in current protocols of our institution. 102 patients with clinical suspicion of thyroid disease were assayed by ECLIA and radioactive techniques. Their differential clinical classification based on laboratory tests was studied as well.

RESULTS

The minimum detectable concentrations coincided with the manufacturer's: <0.005 mU/L for TSH, <0.30 pmol/L for FT4, and <0.30 nmol/L for T3. Functional sensitivity for TSH was 0.044 mU/L. Over the analytical range tested, within-assay imprecision was below 3.2% for TSH, 2.2% for FT4 and 9.6% for T3, and interassay CVs were below 4.0% for TSH, 5.9% for FT4 and 12.9% for T3. Measurement of diluted sera showed the TSH assay to overestimate recoveries by 18.6%. We have compared sera results of the Elecsys ECLIA assays with those obtained from the IRMA (Spectria-Orion Diagnostica) for TSH: TSH (ECLIA) = 0.074+0.953 TSH (IRMA), (r = 0.974; Sy/x = 2.638), and RIA (Coat a Count-DPC) for FT4:FT4 (ECLIA) = 5.043+0.682 FT4 (RIA), (r = 0.770; Sy/x = 4.774) and RIA (Spectria-Orion Diagnostica) for T3: T3(ECLIA) = -0.461+1.084 T3 (RIA), (r = 0.970; Sy/x = 0.412). When sera from 102 patients were processed by both methods, minimal disagreement in the area of diagnostic classification was observed in 8/102 (7.8%) of the cases.

CONCLUSION

The Elecsys 2010 is specially attractive as a routine assay because it is fully automated, obtaining results in only 18 minutes. The analytical assay performance for TSH, FT4 and T3 was shown to be acceptable. Using two different sets of diagnostic tests minimal discrepancies were found in the laboratory assessment for the classification of patients with clinical suspicion of thyroid disease.

摘要

目的

对Elecsys 2010免疫分析系统中促甲状腺激素（TSH）、游离甲状腺素（FT4）和三碘甲状腺原氨酸（T3）的新型电化学发光免疫分析（ECLIA）进行分析评估。基于这些实验室检测评估疑似甲状腺疾病患者的临床分类。

材料与方法

分析评估包括三种分析物的最低检测浓度、批内和批间精密度、TSH的功能灵敏度和线性研究，以及与我院现行方案中FT4和T3的放射免疫分析（RIA）方法以及TSH的免疫放射分析（IRMA）方法进行方法比较。对102例临床疑似甲状腺疾病的患者采用ECLIA和放射技术进行检测。还研究了基于实验室检测的不同临床分类。

结果

最低检测浓度与制造商给出的一致：TSH＜0.005 mU/L，FT4＜0.30 pmol/L，T3＜0.30 nmol/L。TSH的功能灵敏度为0.044 mU/L。在所测试的分析范围内，TSH的批内不精密度低于3.2%，FT4为2.2%，T3为9.6%，批间变异系数TSH低于4.0%，FT4为5.9%，T3为12.9%。稀释血清测量显示TSH检测高估回收率18.6%。我们将Elecsys ECLIA检测的血清结果与TSH的免疫放射分析（Spectria-Orion Diagnostica）结果进行了比较：TSH（ECLIA）=0.074 + 0.953 TSH（IRMA），（r = 0.974；Sy/x = 2.638），以及FT4的放射免疫分析（Coat a Count-DPC）结果：FT4（ECLIA）= 5.043 + 0.682 FT4（RIA），（r = 0.770；Sy/x = 4.774），和T3的放射免疫分析（Spectria-Orion Diagnostica）结果：T3（ECLIA）= -0.461 + 1.084 T3（RIA），（r = 0.970；Sy/x = 0.412）。当用两种方法处理102例患者的血清时，在8/102（7.8%）的病例中观察到诊断分类区域的最小差异。