Performance evaluation of automated magnetic beads extraction method for the measurement of 23 plasma steroids using dual liquid chromatography-tandem mass spectrometry (LC-MS/MS) method

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2026-05-15 Epub Date: 2026-03-07 DOI:10.1016/j.cca.2026.120962

Han Chen , Gang Xu , Mei-juan Zhang , Fu-rong Ying , Hai-xia Huang , He-huan Liu , Jian-rong Yang

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引用次数: 0

Abstract

Objectives

To evaluate the performance of magnetic beads extraction method (MGE) for quantifying plasma steroids using liquid chromatography tandem mass spectrometry (LC-MS/MS).

Methods

The evaluation encompassed calibration linearity, limit of detection (LOD), lower limit of the measuring interval (LLMI), specificity and matrix effects, trueness and recovery, intra- and inter-day precisions, repeatability, dilution consistency and stability of 23 plasma steroids extracted by MGE method were evaluated. The 23 plasma steroids were isolated and analyzed through a single sample preparation and two injections by LC-MS/MS.

Results

All 23 steroids were successfully resolved chromatographically within 12.1 min. The automated MGE method exhibited excellent linearity (R² > 0.995 for all analytes) with coefficients of variation (CVs) ranging from 3.36% to 9.28% at LLMI and from 1.58% to 16.53% at LOD. Additionally, the CVs and average deviation for repeatability were between 0.55% and 7.11%, and − 6.57% to 10.81%, respectively. Both intra-day precision (0.88% to 8.43%) and inter-day precision (0.98% to 6.51%) satisfied the acceptance criteria. The average deviation for trueness and recovery ranged from −13.93% to 9.06%. Moreover, specificity, matrix effect, dilution consistency, and stability were distinctly identified and conformed to guideline requirements. Notably, levels of AD, T, E1, and 17-OHP were significantly elevated in patients with polycystic ovary syndrome (PCOS) (p < 0.05).

Conclusion

The automated MGE method demonstrates high efficiency and reliability for the simultaneous quantification of 23 plasma steroids, offering a promising solution for high-throughput analysis of steroid panels in clinical in the future.

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双液相色谱-串联质谱（LC-MS/MS）自动磁珠提取法测定23种血浆类固醇的性能评价

目的评价磁珠萃取法（MGE）液相色谱-串联质谱（LC-MS/MS）定量血浆甾体激素的性能。方法对MGE法提取的23种血浆甾体激素的校准线性度、检出限（LOD）、测定间隔下限（LLMI）、特异性和基质效应、真实度和回收率、日内和日间精密度、重复性、稀释一致性和稳定性进行评价。采用液相色谱-质谱联用技术（LC-MS/MS）对23种血浆甾体进行分离和分析。结果23种甾体激素均在12.1 min内分离成功。自动化MGE方法线性良好（R2 > 0.995），变异系数（cv）在LLMI范围为3.36% ~ 9.28%，LOD范围为1.58% ~ 16.53%。重复性的cv值为0.55% ~ 7.11%，平均偏差为- 6.57% ~ 10.81%。日内精度（0.88% ~ 8.43%）和日内精度（0.98% ~ 6.51%）均满足验收标准。准确度和回收率的平均偏差范围为- 13.93% ~ 9.06%。此外，特异性、基质效应、稀释一致性和稳定性被明确识别并符合指南要求。值得注意的是，多囊卵巢综合征（PCOS）患者的AD、T、E1和17-OHP水平显著升高（p < 0.05）。结论自动MGE方法可同时定量检测23种血浆类固醇药物，具有较高的效率和可靠性，为今后临床类固醇药物的高通量分析提供了良好的解决方案。

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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.