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一种经过验证的方法,用于在同一装置中使用两种不同的10微升体积吸收微量样本装置对毛细管磷脂酰乙醇16:0/18:1进行定量分析。

A validated method for capillary phosphatidylethanol 16:0/18:1 quantification with two different 10-µl volumetric absorptive microsample devices in the same setup.

作者信息

Andreassen Trine N, Gule Marina, Havnen Hilde, Spigset Olav, Skråstad Ragnhild Bergene

机构信息

Department of Clinical Pharmacology, St. Olavs University Hospital, Trondheim 7006, Norway.

Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim 7030, Norway.

出版信息

J Anal Toxicol. 2025 Apr 12;49(4):231-240. doi: 10.1093/jat/bkaf004.

DOI:10.1093/jat/bkaf004
PMID:39882943
Abstract

There is a growing interest for quantification of drugs in capillary blood. Phosphatidylethanol (PEth) is a biomarker for alcohol intake measured in whole blood, thus making it a candidate for capillary sampling. Our laboratory has been running a method for PEth quantification in venous blood since 2016, and we aimed to expand this method to also include capillary dried blood spot (DBS) samples. Two 10-µl volumetric absorptive microsampling (VAMS) devices, Capitainer®B Vanadate and Mitra®, were included in the method development and validated. Calibrators and quality controls were spiked during automatic sample extraction without the VAMS devices present, making it possible to extract and analyze both types of VAMS samples in the same setup. With the Mitra device, all pre-established validation criteria were fulfilled in the measuring range of 0.03 to 4.0 µM (21-2812 ng/mL), including method comparison with our venous blood method. Capitainer fulfilled all validation criteria, except for the accuracy of samples with PEth levels ≥ 0.5 µM (≥ 352 ng/mL) (deviation -17.1% to -20.5%). The correlation analysis between Capitainer and the venous blood results showed no constant bias, but an acceptable small proportional mean difference of -7.6%. Overall, the method validation results for both Capitainer and Mitra were considered acceptable. Both devices were found to be suitable for the analyses of PEth.

摘要

对毛细血管血中药物定量的兴趣与日俱增。磷脂酰乙醇(PEth)是全血中测量的酒精摄入生物标志物,因此使其成为毛细血管采样的候选对象。自2016年以来,我们实验室一直在运行一种用于静脉血中PEth定量的方法,我们旨在将该方法扩展到也包括毛细血管干血斑(DBS)样本。两种10微升的体积吸收微量采样(VAMS)设备,Capitainer®B钒酸盐和Mitra®,被纳入方法开发并进行了验证。在校准品和质量控制品的自动样品提取过程中,在没有VAMS设备的情况下进行加样,使得可以在同一设置中提取和分析两种类型的VAMS样品。使用Mitra设备,在0.03至4.0微摩尔(21-2812纳克/毫升)的测量范围内满足了所有预先确定的验证标准,包括与我们的静脉血方法的方法比较。Capitainer满足了所有验证标准,但PEth水平≥0.5微摩尔(≥352纳克/毫升)的样品准确性除外(偏差为-17.1%至-20.5%)。Capitainer与静脉血结果之间的相关性分析显示没有恒定偏差,但比例平均差异为-7.6%,可以接受。总体而言,Capitainer和Mitra的方法验证结果均被认为可以接受。两种设备都被发现适用于PEth的分析。

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