Development and evaluation of a novel non-competitive MAGLUMI estradiol chemiluminescence immunoassay

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-05-13 DOI:10.1016/j.cca.2025.120356

Yueying Wang , Yun Zhang , Zhonggang Fang , Ran Xu , Qiang Luo , Jian Liu , Yixiong Yao , Wenhai Liang , Ruiwei Gan , Tinghua Li , Zhifang Lin

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引用次数: 0

Abstract

Estradiol is a key estrogen, and measuring its circulating levels is essential for evaluating ovarian function, monitoring follicular development, and assessing reproductive health. In several patient samples, estradiol levels can be extremely low, surpassing the detection capabilities of current competitive immunoassays. This research introduces a non-competitive MAGLUMI estradiol chemiluminescence immunoassay (CLIA) that utilizes a two-step sandwich approach to quantify estradiol levels. The sandwich-based detection system for estradiol was established by preparing monoclonal antibodies for estradiol-primary antibody immune complexes. To optimize the performance of the reagents, we screened the ideal feeding ratios of the primary antibody to magnetic beads and the secondary antibody to ABEI, and then determined the best reaction system. The novel system exhibited higher sensitivity and precision compared to competitive assays. Besides superiority in limit of blank (LoB, 1.0 × 10⁻³ μg/L), limit of detection (LoD, 5.0 × 10⁻³ μg/L), limit of quantification (LoQ, 9.3 × 10⁻³ μg/L) and coefficient of variation for reproducibility (CV, 3.15 %∼9.47 %). The cross-reactivity with estrone, estriol, fulvestrant, abemaciclib and estradiol valerate is notably minimized. Meanwhile, the quantification result of this system strongly correlates with LC-MS/MS (y = 1.008x + 0.8949, R² = 0.981). In conclusion, the non-competitive reagents developed in this study for estradiol detection outperform existing competitive reagents, providing more reliable results for clinical applications.

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一种新型非竞争性MAGLUMI雌二醇化学发光免疫分析法的开发与评价

雌二醇是一种重要的雌激素，测量其循环水平对评估卵巢功能、监测卵泡发育和评估生殖健康至关重要。在一些患者样本中，雌二醇水平可能极低，超过了当前竞争性免疫测定法的检测能力。本研究介绍了一种非竞争性的MAGLUMI雌二醇化学发光免疫分析法（CLIA），该方法采用两步夹心法来量化雌二醇水平。通过制备雌二醇-一抗免疫复合物单克隆抗体，建立了基于三明治的雌二醇检测系统。为了优化试剂的性能，我们筛选了一抗对磁珠和二抗对ABEI的理想投料比例，确定了最佳反应体系。与现有的分析方法相比，该系统具有更高的灵敏度和精密度。空白限（LoB, 1.0 × 10−3 μg/L）、检出限（LoD, 5.0 × 10−3 μg/L）、定量限（LoQ, 9.3 × 10−3 μg/L）和重复性变异系数（CV, 3.15% ~ 9.47%）均具有优势。与雌酮、雌三醇、氟维司汀、阿贝马昔利和戊酸雌二醇的交叉反应性明显降低。同时，该体系的定量结果与LC-MS/MS有较强的相关性（y = 1.008x + 0.8949, R2 = 0.981）。综上所述，本研究开发的雌二醇检测非竞争性试剂优于现有的竞争性试剂，为临床应用提供了更可靠的结果。

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.