抗苗勒管激素的测定：基于ABEI的全自动免疫测定法的初步评估
Measurement of Anti-Mullerian Hormone: Preliminary Evaluation of an ABEI-Based Fully Automated Immunoassay.
作者信息
Gruson Damien, Siham Akdim, Fillée Catherine
机构信息
Deportment of Clinical Biochemistry, Cliniques Universitaires St-Luc and Universite Catholique de Louvain, Brussels, Belgium.
Pôle de recherche en Endocrinologie, Diabète et Nutrition, Institut de Recherche Experimentale et Clinique, Cliniques Universitaires St-Luc and Université Catholique de Louvain, Brussels, Belgium.
出版信息
EJIFCC. 2023 Apr 18;34(1):4-9. eCollection 2023 Apr.
BACKGROUND
The added value of Anti-Müllerian hormone (AMH) measurement is recognized for several clinical applications such as assessment of the ovarian reserve, monitoring of fertilization protocol or in the field of oncofertility. Our study objective was to determine the performances of a novel fully automated chemiluminescent assay for AMH testing.
METHODS
We evaluated the performances of the Maglumi 800 AMH chemiluminescent immunoassay that applies N-(4-Aminobutyl)-N-ethylisoluminol (ABEI) labels. Assay imprecision was assessed with two levels of control materials. Method comparison was performed with an ultrasensitive AMH ELISA assay (Ansh Laboratories, Inc, Webster, TX, USA) with 88 patients' samples.
RESULTS
The within-run and between-run coefficients of variation (CVs) were below for both low and high internal quality controls. The automated and ELISA methods were significantly correlated. Bland-Altman plot evidenced a bias between the methods with a mean bias of 0.6 ng/mL.
CONCLUSIONS
Our preliminary evaluation showed overall good analytical performances for the Maglumi AMH fully automated immunoassay and good concordance with a routinely used assay.
背景
抗苗勒管激素（AMH）检测的附加价值在卵巢储备评估、受精方案监测或肿瘤生育领域等多种临床应用中得到认可。我们的研究目的是确定一种新型全自动化学发光法检测AMH的性能。
方法
我们评估了应用N-(4-氨丁基)-N-乙基异鲁米诺（ABEI）标记的迈瑞800 AMH化学发光免疫分析法的性能。使用两种水平的对照材料评估分析不精密度。对88例患者样本采用超灵敏AMH酶联免疫吸附测定法（美国得克萨斯州韦伯斯特市安仕实验室公司）进行方法比较。
结果
低、高内部质量控制的批内和批间变异系数（CV）均低于[具体数值未给出]。自动化方法和酶联免疫吸附测定法显著相关。布兰德-奥特曼图显示两种方法之间存在偏差，平均偏差为0.6 ng/mL。
结论
我们的初步评估表明，迈瑞AMH全自动免疫分析法总体具有良好的分析性能，且与常规使用的检测方法具有良好的一致性。
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