Wei Ruhan, Bowers Kathleen, Kroner Grace M, Payto Drew, Colón-Franco Jessica M
Department of Laboratory Medicine, Cleveland Clinic, Cleveland, OH, USA.
Pract Lab Med. 2022 May 10;31:e00279. doi: 10.1016/j.plabm.2022.e00279. eCollection 2022 Aug.
Androstenedione (ASD) is a biomarker used in the diagnostic workup of hyperandrogenism, congenital adrenal hyperplasia, premature adrenarche, and polycystic ovary syndrome (PCOS). The Elecsys ASD competitive electrochemiluminescence immunoassay (Roche Diagnostics, Indianapolis, IN) is a new assay recently available in the US.
This study evaluated the analytical and clinical performance of the Elecsys ASD assay.
DESIGN & METHODS: We evaluated the linearity/analytical measuring range (AMR), precision, and accuracy of the Elecsys ASD assay on the cobas e601 analyzer. ASD was measured in serum/plasma in the Elecsys ASD, Immulite (Siemens Medical Solutions USA, Inc. Malvern, PA), and LC-MS/MS assays. Reference intervals (RI) were evaluated across genders, menopausal status, and in children. Statistical analysis was performed using EP evaluator and R program.
The Elecsys ASD assay had a linear response across the AMR. The intra- and inter-assay coefficients of variation at various concentrations were ≤4.5%. The Elecsys ASD assay had a mean difference of -0.04 ng/mL (-1.7%) with the LC-MS/MS assay, whereas the Immulite assay had a mean difference of 1.17 ng/mL (66%) and -1.22 ng/mL (-38%) compared to the LC-MS/MS and Elecsys ASD assays, respectively. The Roche recommended RIs for healthy men (0.280-1.52 ng/mL) and postmenopausal women (0.187-1.07 ng/mL) were successfully verified. The RIs for children were adopted from published data. For pre-menopausal women, a RI of <1.60 ng/mL was established. The ASD concentrations in women with and without PCOS overlapped.
The Elecsys ASD assay has superior comparability to the LC-MS/MS assay than the Immulite assay.
雄烯二酮（ASD）是一种生物标志物，用于高雄激素血症、先天性肾上腺皮质增生症、肾上腺功能初现过早和多囊卵巢综合征（PCOS）的诊断检查。Elecsys ASD竞争电化学发光免疫分析法（罗氏诊断公司，印第安纳波利斯，印第安纳州）是一种最近在美国上市的新检测方法。
本研究评估了Elecsys ASD检测方法的分析性能和临床性能。
我们在cobas e601分析仪上评估了Elecsys ASD检测方法的线性/分析测量范围（AMR）、精密度和准确性。在Elecsys ASD、Immulite（西门子医疗解决方案美国公司，马尔文，宾夕法尼亚州）和液相色谱-串联质谱（LC-MS/MS）检测方法中对血清/血浆中的ASD进行测量。对不同性别、绝经状态和儿童的参考区间（RI）进行了评估。使用EP评估器和R程序进行统计分析。
Elecsys ASD检测方法在整个AMR范围内呈线性响应。不同浓度下的批内和批间变异系数≤4.5%。Elecsys ASD检测方法与LC-MS/MS检测方法的平均差异为-0.04 ng/mL（-1.7%），而Immulite检测方法与LC-MS/MS和Elecsys ASD检测方法相比，平均差异分别为1.17 ng/mL（66%）和-1.22 ng/mL（-38%）。罗氏推荐的健康男性（0.280 - 1.52 ng/mL）和绝经后女性（0.187 - 1.07 ng/mL）的RI得到了成功验证。儿童的RI采用已发表的数据。对于绝经前女性，确定的RI<1.60 ng/mL。患有和未患有PCOS的女性的ASD浓度有重叠。
与Immulite检测方法相比，Elecsys ASD检测方法与LC-MS/MS检测方法具有更好的可比性。
