Clin Lab. 2021 Apr 1;67(4). doi: 10.7754/Clin.Lab.2020.200806.
The study aimed to assess the analytical performance of the Access Sensitive Estradiol (SNSE2) Assay on a DxI800 (Beckman Coulter, Brea, CA, USA) and compared it with a Cobas E 601 (Roche Diagnostics, Penzberg, Germany).
SNSE2 was assessed for imprecision, accuracy, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ), linearity, interference, and carryover. Two hundred and fourteen samples were run on both instruments. Bland-Altman plots, Passing-Bablok regression, and concordance correlation coefficient (CCC) graphs were used for comparisons.
Access SNSE2 showed appropriate assay performance characteristics in terms of imprecision, LoB, LoD, LoQ, linearity, and interference. The Bland-Altman analysis of DxI 800 yielded negative bias from Cobas E 601 and the deviations for E2 ≤ 150 pmol/L, 150 - 500 pmol/L, and ≥ 500 pmol/L were found as 0.8%, -15%, and -8.9%, respectively. DxI 800 and E170 systems showed poor agreement for E2 levels ≤ 150 pmol/L and 150 - 500 pmol/L with CCC values of 0.7404 and 0.8342. For E2 levels ≤ 150 pmol/L there was a significant amount of both proportional and constant error with the highest slope of 1.518 (1.269 to 1.761) and an intercept of -45.08 (-66.09 to 18.78, respectively, according to the Passing-Bablok regression analysis).
Analytical performance for SNSE2 assay was found appropriate. However, attempts to improve harmonization and standardization across assays do not seem to contribute much for E2 measurements. Results obtained with different systems cannot be used interchangeably and follow up of patients should be done with the same system.
本研究旨在评估 Access Sensitive Estradiol（SNSE2）分析在 DxI800（贝克曼库尔特，Brea，CA，美国）上的分析性能，并将其与 Cobas E 601（罗氏诊断，彭茨贝格，德国）进行比较。
评估 SNSE2 的不精密度、准确度、空白限（LoB）、检测限（LoD）、定量限（LoQ）、线性、干扰和携带污染。在两台仪器上运行了 214 个样本。使用 Bland-Altman 图、Passing-Bablok 回归和一致性相关系数（CCC）图进行比较。
Access SNSE2 在不精密度、LoB、LoD、LoQ、线性和干扰方面表现出适当的分析性能特征。DxI 800 的 Bland-Altman 分析显示，与 Cobas E 601 相比存在负偏倚，E2≤150 pmol/L、150-500 pmol/L 和≥500 pmol/L 的偏差分别为 0.8%、-15%和-8.9%。DxI 800 和 E170 系统在 E2 水平≤150 pmol/L 和 150-500 pmol/L 时显示出较差的一致性，CCC 值分别为 0.7404 和 0.8342。对于 E2 水平≤150 pmol/L，存在大量的比例和常数误差，斜率最高为 1.518（1.269 至 1.761），截距为-45.08（-66.09 至 18.78，根据 Passing-Bablok 回归分析）。
SNSE2 分析的分析性能被认为是适当的。然而，试图在分析之间提高协调性和标准化似乎对 E2 测量没有多大贡献。不同系统获得的结果不能互换使用，应使用相同的系统对患者进行随访。
