促甲状腺激素和游离甲状腺素在 ADVIA Centaur 免疫分析系统上的检测：分析性能的多中心评估。

Thyroid-stimulating hormone and free thyroxine on the ADVIA Centaur immunoassay system: a multicenter assessment of analytical performance.

机构信息

Laboratoire d'Hormonologie, Hôpitaux Universitaires de Strasbourg, 1 place de l'Hôpital, 67091 Strasbourg Cedex, France.

出版信息

Clin Biochem. 2013 Sep;46(13-14):1305-8. doi: 10.1016/j.clinbiochem.2013.04.015. Epub 2013 Apr 26.

DOI:10.1016/j.clinbiochem.2013.04.015

PMID:23628596

Abstract

OBJECTIVES

We assessed the analytical performance of the TSH and FT4 assays on ADVIA Centaur in a multicenter national evaluation.

DESIGN AND METHODS

A precision study and a method comparison were performed. Reference values stated by the manufacturer were checked from 379 normal subjects.

RESULTS

For TSH and FT4, the intra-assay CVs were below 2.3 and 5.2%, respectively, and the inter-assay CVs below 4.4% and 7.2%, respectively. Therefore, the precision and reproducibility were acceptable. Bland-Altman bias plots revealed good correlation and agreement with Cobas assays. TSH and FT4 data yielded reference ranges of 0.64-3.24 mIU/L and 10.5-18.9 pmol/L, respectively.

CONCLUSION

These assays demonstrate reliable characteristics. The reference ranges obtained can be used for interpretation of thyroid function.

摘要

目的

我们评估了 ADVIA Centaur 上 TSH 和 FT4 检测的分析性能，这是一项多中心的全国性评估。

设计和方法

进行了精密度研究和方法比较。检查了 379 名正常受试者的制造商规定的参考值。

结果

对于 TSH 和 FT4，其日内 CV 分别低于 2.3%和 5.2%，而日间 CV 分别低于 4.4%和 7.2%。因此，精密度和重现性是可以接受的。Bland-Altman 偏倚图显示与 Cobas 检测具有良好的相关性和一致性。TSH 和 FT4 的参考范围分别为 0.64-3.24 mIU/L 和 10.5-18.9 pmol/L。