三种免疫分析系统测定血清抗苗勒管激素的比较

Comparison of Three Immunoassay Systems for Determining Serum Anti-Mullerian Hormone.

作者信息

Feng Yixi, Chen Yanqun, Liu Chunming, Fu Jinjian, Xu Jianhua

出版信息

Clin Lab. 2021 Apr 1;67(4). doi: 10.7754/Clin.Lab.2020.200814.

DOI:10.7754/Clin.Lab.2020.200814

PMID:33865260

Abstract

BACKGROUND

Serum anti-Mullerian hormone (AMH) is a dimeric glycoprotein of the transforming growth factor-β (TGF-β) family of growth and serves as a key biomarker of folliculogenesis as well as steroidogenesis within ovaries. Cobas E601, UniCel DxI 800 and iFlash3000 are automated immunoassay systems which are widely used to measure serum AMH levels in the blood. However, the correlations of serum AMH measured by the three automated immunoassay systems are not well recognized, the aim of this study is to compare the performance of the three automated immunoassay systems and record the correlation of serum AMH concentrations.

METHODS

Serum AMH concentrations were measured in 100 serum samples using the UniCel DxI 800, Cobas E601, and iFlash 3000 automated immunoassay systems on the same day. Passing-Bablok regression analysis and Bland-Altman plot analysis were used to compare the system methods. The concordance correlation coefficient was analyzed to explain interrater agreement between the three immunoassay systems.

RESULTS

Bland-Altman plot showed that the concentrations of AMH measured by UniCel DxI 800 were about 0.15 times higher than that measured using Cobas E601, the concentrations of AMH measured by UniCel DxI 800 were about 0.05 times higher than that measured using iFlash 3000, serum AMH concentrations measured by the iFlash3000 were about 0.19 times higher than that measured using Cobas E601. The concordance correlation coefficient ρc was 0.921, 0.909 and 0.978 for the UniCel DxI 800 versus the Cobas E601, the iFlash 3000 versus the UniCel DxI 800, and the iFlash3000 versus the Cobas E601, respectively.

CONCLUSIONS

The three measurement systems have good correlation with each other for determining serum AMH.

摘要

背景

血清抗苗勒管激素（AMH）是转化生长因子-β（TGF-β）生长因子家族的一种二聚体糖蛋白，是卵泡发生以及卵巢内类固醇生成的关键生物标志物。Cobas E601、UniCel DxI 800和iFlash3000是自动化免疫分析系统，广泛用于测量血液中的血清AMH水平。然而，这三种自动化免疫分析系统所测血清AMH的相关性尚未得到充分认识，本研究的目的是比较这三种自动化免疫分析系统的性能，并记录血清AMH浓度的相关性。

方法

同一天使用UniCel DxI 800、Cobas E601和iFlash 3000自动化免疫分析系统对100份血清样本进行血清AMH浓度测定。采用Passing-Bablok回归分析和Bland-Altman图分析比较系统方法。分析一致性相关系数以解释三种免疫分析系统之间的评分者间一致性。

结果

Bland-Altman图显示，UniCel DxI 800所测AMH浓度比使用Cobas E601所测浓度高约0.15倍，UniCel DxI 800所测AMH浓度比使用iFlash 3000所测浓度高约0.05倍，iFlash3000所测血清AMH浓度比使用Cobas E601所测浓度高约0.19倍。UniCel DxI 800与Cobas E601、iFlash 3000与UniCel DxI 800、iFlash3000与Cobas E601的一致性相关系数ρc分别为0.921、0.909和0.978。