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用于准确定量磷脂酰乙醇的干血斑采样装置之间校准可转移性的评估与交叉验证

Assessment and cross-validation of calibration transferability between dried blood spot sampling devices for accurate quantification of phosphatidylethanol.

作者信息

Hose J, Juebner M, Thevis M, Andresen-Streichert H

机构信息

Department of Toxicology, Institute of Legal Medicine, University of Cologne, Faculty of Medicine and University Hospital, Cologne, Germany.

Centre for Preventive Doping Research/Institute of Biochemistry, German Sport University Cologne, Cologne, Germany.

出版信息

Anal Bioanal Chem. 2025 May 15. doi: 10.1007/s00216-025-05897-x.

Abstract

Phosphatidylethanol (PEth) is a direct alcohol biomarker which is used in a variety of clinical and forensic contexts. Due to its limited stability in whole blood, PEth is routinely analysed using dried blood spots (DBS). There are many different commercially available sampling systems for DBS, but data on their comparability is scarce. The aim of this study was to develop and validate a LC-MS/MS method for the quantification of PEth 16:0/18:1 and PEth 16:0/18:2 for three different DBS sampling systems: Whatman™ filter paper (903 Protein Saver Cards), Mitra and CapitainerB Vanadate. The transferability of calibration curves and their applicability across these devices should be assessed. The results showed that DBS of all devices could be prepared and analysed using the same procedure. Validation was successful for the devices. The accuracy of QCs was best if quantified using the matching DBS sampling device calibration curve (bias < 15 %). Higher, but still acceptable, bias values were observed when using a Whatman™ calibration curve to quantify PEth in DBS of the CapitainerB Vanadate system and vice versa. Mitra QCs should only be quantified using device-specific calibration curves, as in all other cases, accuracy exceeded the limit of 15 %. We recommend analysing samples using device-specific calibrations at all times, as determined PEth concentrations might be crucial for patients and should not be subjected to any avoidable uncertainty.

摘要

磷脂酰乙醇(PEth)是一种直接酒精生物标志物,用于多种临床和法医环境。由于其在全血中的稳定性有限,PEth通常使用干血斑(DBS)进行分析。有许多不同的市售DBS采样系统,但关于它们可比性的数据很少。本研究的目的是开发并验证一种液相色谱-串联质谱(LC-MS/MS)方法,用于定量三种不同DBS采样系统中的PEth 16:0/18:1和PEth 16:0/18:2:Whatman™滤纸(903蛋白保存卡)、Mitra和CapitainerB钒酸盐。应评估校准曲线的转移性及其在这些设备中的适用性。结果表明,所有设备的DBS都可以使用相同的程序制备和分析。这些设备的验证是成功的。如果使用匹配的DBS采样设备校准曲线进行定量,质控品的准确性最佳(偏差<15%)。当使用Whatman™校准曲线对CapitainerB钒酸盐系统的DBS中的PEth进行定量时,观察到较高但仍可接受的偏差值,反之亦然。Mitra质控品应仅使用特定于设备的校准曲线进行定量,因为在所有其他情况下,准确性超过了15%的限度。我们建议始终使用特定于设备的校准来分析样品,因为确定的PEth浓度对患者可能至关重要,不应受到任何可避免的不确定性影响。

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