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驾驶大麻影响:陷阱,验证,和超高效液相色谱 - 串联质谱法的质量控制用于定量唾液中四氢大麻酚收集的StatSure,Quantisal,或Certus 收集器。

Driving under the influence of cannabis: pitfalls, validation, and quality control of a UPLC-MS/MS method for the quantification of tetrahydrocannabinol in oral fluid collected with StatSure, Quantisal, or Certus collector.

机构信息

Laboratory of Toxicology, National Institute of Criminalistics and Criminology, Brussels, Belgium.

出版信息

Ther Drug Monit. 2013 Feb;35(1):101-11. doi: 10.1097/FTD.0b013e318278dbe4.

Abstract

BACKGROUND

"Driving under the influence of drugs" (DUID) has a large impact on the worldwide mortality risk. Therefore, DUID legislations based on impairment or analytical limits are adopted. Drug detection in oral fluid is of interest due to the ease of sampling during roadside controls. The prevalence of Δ9-tetrahydrocannabinol (THC) in seriously injured drivers ranges from 0.5% to 7.6% in Europe. For these reasons, the quantification of THC in oral fluid collected with 3 alternative on-site collectors is presented and discussed in this publication.

METHODS

An ultra-performance liquid chromatography-mass spectrometric quantification method for THC in oral fluid samples collected with the StatSure (Diagnostic Systems), Quantisal (Immunalysis), and Certus (Concateno) devices was validated according to the international guidelines. Small sample volumes of 100-200 μL were extracted using hexane. Special attention was paid to factors such as matrix effects, THC adsorption onto the collector, and stability in the collection fluid.

RESULTS

A relatively high-throughput analysis was developed and validated according to ISO 17025 requirements. Although the effects of the matrix on the quantification could be minimized using a deuterated internal standard, and stability was acceptable according the validation data, adsorption of THC onto the collectors was a problem. For the StatSure device, THC was totally recovered from the collector pad after storage for 24 hours at room temperature or 7 days at 4°C. A loss of 15%-25% was observed for the Quantisal collector, whereas the recovery from the Certus device was irreproducible (relative standard deviation, 44%-85%) and low (29%-80%). During the roadside setting, a practical problem arose: small volumes of oral fluid (eg, 300 μL) were collected. However, THC was easily detected and concentrations ranged from 8 to 922 ng/mL in neat oral fluid.

CONCLUSION

A relatively high-throughput analysis (40 samples in 4 hours) adapted for routine DUID analysis was developed and validated for THC quantification in oral fluid samples collected from drivers under the influence of cannabis.

摘要

背景

“药物影响下驾驶”(DUID)对全球死亡率有很大影响。因此,基于损伤或分析限制的 DUID 法规被采用。由于在路边控制时易于采样,因此对口腔液中的药物检测很感兴趣。在欧洲,严重受伤驾驶员中 Δ9-四氢大麻酚(THC)的流行率为 0.5%至 7.6%。出于这些原因,本文介绍并讨论了使用 3 种替代现场采集器采集的口腔液中 THC 的定量检测。

方法

根据国际指南,对使用 StatSure(Diagnostic Systems)、Quantisal(Immunalysis)和 Certus(Concateno)设备采集的口腔液样品中 THC 的超高效液相色谱-质谱定量方法进行了验证。使用正己烷提取 100-200μL 的小样本量。特别注意了基质效应、THC 对收集器的吸附以及收集液中的稳定性等因素。

结果

根据 ISO 17025 的要求开发并验证了一种高通量分析方法。尽管使用氘代内标可以最小化基质对定量的影响,并且根据验证数据稳定性可以接受,但 THC 对收集器的吸附是一个问题。对于 StatSure 设备,THC 在室温下储存 24 小时或在 4°C 下储存 7 天后可从收集垫中完全回收。对于 Quantisal 收集器,观察到 15%-25%的损失,而 Certus 设备的回收是不可重复的(相对标准偏差为 44%-85%)且较低(29%-80%)。在路边环境中,出现了一个实际问题:采集的口腔液量较小(例如 300μL)。然而,很容易检测到 THC,在未稀释的口腔液中浓度范围为 8 至 922ng/mL。

结论

开发并验证了一种适用于常规 DUID 分析的高通量分析(4 小时内 40 个样本),用于检测大麻影响下驾驶员口腔液中 THC 的定量检测。

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