Determination of testosterone by liquid Chromatography–Tandem mass spectrometry in dried plasma obtained from capillary blood using the HealthID PSD microsampling device

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-06-11 DOI:10.1016/j.cca.2025.120421

Amanda Pacheco Bondan , Ana Paula Grando , Eduarda Milena Reichert , Giovana Piva Peteffi , Giovanna da Silva Grassi , Maitê de Moraes Machado , Roberta Zilles Hahn , Marina Venzon Antunes , Eduardo Guimarães Camargo , Mariele Feiffer Charão , Rafael Linden

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Abstract

Monitoring testosterone (T) levels is essential in various clinical contexts, but traditional venous sampling is invasive and limits access. This study describes the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to quantify T in dried plasma spot (DPS) samples obtained from capillary blood using the HealthID PSD microsampling device. A chloride-based correction of plasma volume in the DPS and a multiplication factor were applied to estimate venous plasma concentrations. The method showed linearity from 1.63 to 104.02 nmol/L, with accuracy ranging from 96.8 % to 105.2 % and precision between 1.90 % and 7.24 %. Matrix effects were adequately corrected by the internal standard, and extraction yield exceeded 89 %. T in DPS samples was stable for up to 10 days at room temperature and 40 °C. Clinical validation involved 104 volunteers, including cisgender men and transgender individuals on hormone therapy. A strong correlation was observed between DPS-derived and venous plasma testosterone levels (r = 0.950), and the percent total error (TE%) of 16.41 % met the desirable performance criterion derived from biological variation data. The method proved robust against hematocrit variation and sample volume differences. This is the first report on T quantification using a capillary plasma separation device, highlighting the potential of the HealthID PSD for simplified, decentralized T monitoring. The approach offers practical advantages in collection, transport, and storage, making it a promising alternative to conventional phlebotomy for clinical applications.

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使用HealthID PSD微采样装置，液相色谱-串联质谱法测定毛细管血中干燥血浆中的睾酮

监测睾酮(T)水平在各种临床情况下是必不可少的，但传统的静脉取样是侵入性的，并且限制了获取。本研究描述了一种液相色谱-串联质谱（LC-MS/MS）方法的开发和验证，该方法使用HealthID PSD微采样装置定量从毛细管血液中获得的干燥血浆斑点（DPS）样品中的T。DPS中基于氯离子的血浆体积校正和乘法因子用于估计静脉血浆浓度。方法线性范围为1.63 ~ 104.02 nmol/L，准确度为96.8% ~ 105.2%，精密度为1.90% ~ 7.24%。内标法充分修正了基质效应，提取率超过89%。DPS样品中的T在室温和40℃下稳定达10天。临床验证涉及104名志愿者，包括接受激素治疗的顺性男性和变性人。dps与静脉血浆睾酮水平之间存在很强的相关性（r = 0.950），总误差百分比（TE%）为16.41%，符合生物变异数据得出的理想性能标准。该方法对红细胞比容变化和样品体积差异具有鲁棒性。这是第一份使用毛细管血浆分离装置定量T的报告，强调了HealthID PSD在简化、分散T监测方面的潜力。该方法在收集、运输和储存方面具有实际优势，使其成为临床应用中传统静脉切开术的有希望的替代方法。

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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.