Field Detection of Drugs of Abuse in Oral Fluid Using the Alere™ DDS®2 Mobile Test System with Confirmation by Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS).

Field Detection of Drugs of Abuse in Oral Fluid Using the Alere™ DDS®2 Mobile Test System with Confirmation by Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS).
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使用 Alere™ DDS®2 移动测试系统现场检测口腔液中的滥用药物,并通过液相色谱串联质谱 (LC-MS/MS) 进行确认。

DOI:
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发表时间:
2018
影响因子:
2.5
通讯作者:
B. Logan
B. Logan
中科院分区:
医学3区
文献类型:
--
作者:
A. Krotulski;A. L. Mohr;Melissa Friscia;B. Logan

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随着便携式测试设备的引入,在路边收集和分析口服液中的药物变得更加可行,例如Alere™DDS®2移动测试系统(DDS®2)。这项研究的目的是将DDS®2的现场结果与基于实验室的验证性分析进行比较,以检测人体滥用药物。作为机构审查委员会批准的一项更大规模研究的一部分,在美国佛罗里达州迈阿密的一个音乐节上,从每位参与者那里收集了两个样本。其中一个样本使用DDS®2进行现场筛选,并使用采集设备的Quantisal™收集确认样本并提交实验室进行检测。总共有124名受试者参与了这项研究,提供了两个同期的样本。DDS®2现场检测结果显示,三角洲-9-四氢大麻酚(THC)(n=27)、可卡因(n=12)、苯丙胺(n=3)、甲基苯丙胺(n=3)和苯二氮卓(n=1)呈阳性结果。未检测到阿片类药物阳性样本。对于可卡因、苯丙胺、甲基苯丙胺和苯二氮卓类药物,DDS®2的敏感度、特异度和准确率均为100%。对于THC,DDS®2的敏感度为90%,特异度为100%,准确度为97.5%,确认阈值与制造商宣传的截止值相符。当这一确认阈值降低到分析检测下限(即1 ng/mL)时,THC的表观仪器性能会变差,这是因为在DDS®2上检测为阴性的确认测试中有更多样品呈阳性,这表明需要在制造商截止和分析报告下限之间建立关联。这些来自吸毒者的结果表明了现场检测的价值,并说明了选择适当的确认截止浓度对于药物使用的绩效评估和检测的意义。
The collection and analysis of drugs in oral fluid (OF) at the roadside has become more feasible with the introduction of portable testing devices such as the Alere™ DDS®2 Mobile Test System (DDS®2). The objective of this study was to compare the on-site results for the DDS®2 to laboratory-based confirmatory assays with respect to detection of drugs of abuse in human subjects. As part of a larger Institutional Review Board approved study, two OF samples were collected from each participant at a music festival in Miami, FL, USA. One OF sample was field screened using the DDS®2, and a confirmatory OF sample was collected using the Quantisal™ OF collection device and submitted to the laboratory for testing. In total, 124 subjects participated in this study providing two contemporaneous OF samples. DDS®2 field screening yielded positive results for delta-9-tetrahydrocannabinol (THC) (n = 27), cocaine (n = 12), amphetamine (n = 3), methamphetamine (n = 3) and benzodiazepine (n = 1). No opiate-positive OF samples were detected. For cocaine, amphetamine, methamphetamine and benzodiazepines, the DDS®2 displayed sensitivity, specificity and accuracy of 100%. For THC, the DDS®2 displayed sensitivity of 90%, specificity of 100% and accuracy of 97.5%, when the threshold for confirmation matched that of the manufacturers advertised cut-off. When this confirmatory threshold was lowered to the analytical limit of detection (i.e., 1 ng/mL), apparent device performance for THC was poorer due to additional samples testing positive by confirmatory assay that had tested negative on the DDS®2, demonstrating a need for correlation between manufacturer cut-off and analytical reporting limit. These results from drug-using subjects demonstrate the value of field-based OF testing, and illustrate the significance of selecting an appropriate confirmation cut-off concentration with respect to performance evaluation and detection of drug use.