自动化荧光免疫分析系统与罗氏 Elecsys 和贝克曼库尔特 Access 2 检测抗缪勒管激素的比较。
Comparison of the Automated Fluorescent Immunoassay System With Roche Elecsys and Beckman Coulter Access 2 Assays for Anti-Müllerian Hormone Measurement.
机构信息
I-dream Clinic, Department of Obstetrics and Gynecology, MizMedi Hospital, Seoul, Korea.
Deagu Cha Fertility Center, CHA University, Daegu, Korea.
出版信息
Ann Lab Med. 2022 Jan 1;42(1):47-53. doi: 10.3343/alm.2022.42.1.47.
BACKGROUND
Since 2017, automated assays have been used in most clinical laboratories for anti-Müllerian hormone (AMH) level measurement. We evaluated the analytical performance of the newly developed automated fluorescent immunoassay system (AFIAS) AMH assay (Boditech Med, Gangwon-do, Korea) in comparison with the Roche Elecsys and Beckman Coulter Access 2 AMH assays.
METHODS
Analytical performance of the AFIAS AMH assay was assessed in terms of linearity, repeatability, and within-laboratory precision (CV%) using human recombinant AMH samples according to the Clinical and Laboratory Standards Institute (CLSI) guidelines EP05 and EP06. Using 293 serum samples collected from an infertility clinic, the AMH levels were compared across AFIAS, Elecsys, and Access 2 AMH assays according to the CLSI EP09 guidelines.
RESULTS
The AFIAS AMH assay results were linear across the measurement range of 0.420-72.386 pmol/L AMH, with repeatability of 6.341%. CV% of the AFIAS AMH assay for three levels of control, 1.786, 7.143, and 56.857 pmol/L, were 5.801%, 5.714%, and 6.228%, respectively. The results of the three AMH assays showed strong correlation: AFIAS and Elecsys [slope, 1.055 (95% confidence interval (CI), 1.022-1.088) and Spearman's rho, 0.978 (95% CI, 0.973-0.983)], Elecsys and Access 2 [slope, 0.813 (95% CI, 0.791-0.834) and Spearman's rho, 0.986 (95% CI, 0.983-0.989)], and AFIAS and Access 2 [slope, 0.836 (95% CI, 0.821-0.853) and Spearman's rho, 0.984 (95% CI, 0.980-0.988)].
CONCLUSIONS
The AFIAS AMH assay may be an alternative to the Roche Elecsys and Beckman Coulter Access 2 AMH assays.
背景
自 2017 年以来，自动化检测已在大多数临床实验室中用于抗苗勒管激素（AMH）水平的测量。我们通过与罗氏 Elecsys 和贝克曼库尔特 Access 2 AMH 检测进行比较，评估了新开发的自动化荧光免疫分析系统（AFIAS）AMH 检测的分析性能。
方法
根据临床和实验室标准协会（CLSI）EP05 和 EP06 指南，我们使用人重组 AMH 样本评估了 AFIAS AMH 检测的线性、重复性和实验室内精密度（%CV）。使用从不孕不育诊所收集的 293 份血清样本，根据 CLSI EP09 指南，比较了 AFIAS、Elecsys 和 Access 2 AMH 检测之间的 AMH 水平。
结果
AFIAS AMH 检测结果在 0.420-72.386 pmol/L AMH 的测量范围内呈线性，重复性为 6.341%。三个水平的控制品，即 1.786、7.143 和 56.857 pmol/L，AFIAS AMH 检测的 CV%分别为 5.801%、5.714%和 6.228%。三种 AMH 检测结果具有很强的相关性：AFIAS 和 Elecsys [斜率，1.055（95%置信区间（CI），1.022-1.088）和 Spearman's rho，0.978（95% CI，0.973-0.983）]，Elecsys 和 Access 2 [斜率，0.813（95% CI，0.791-0.834）和 Spearman's rho，0.986（95% CI，0.983-0.989）]，以及 AFIAS 和 Access 2 [斜率，0.836（95% CI，0.821-0.853）和 Spearman's rho，0.984（95% CI，0.980-0.988）]。
结论
AFIAS AMH 检测可能是罗氏 Elecsys 和贝克曼库尔特 Access 2 AMH 检测的替代方法。
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