Simultaneous detection of 19 drugs of abuse on dried urine spot by liquid chromatography-tandem mass spectrometry
Simultaneous detection of 19 drugs of abuse on dried urine spot by liquid chromatography-tandem mass spectrometry
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DOI：
10.1016/j.clinbiochem.2013.03.027
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发表时间：
2013-08-01
影响因子：
2.8
通讯作者：
Sadrzadeh, S. M. Hossein
中科院分区：
文献类型：
--
作者：
Lee, Yungkang;Lai, Keane K. Y.;Sadrzadeh, S. M. Hossein
背景：针对药物滥用试验(DAT)的免疫分析方法缺乏特异性，以及对其与反射确证试验成本的担忧，促使我们研究了干尿斑(DUS)和LC-MS/MS作为替代方法的应用。方法：根据FDA和CLSI发布的指南进行方法开发和验证。结果：在本研究中，我们建立并验证了DUS-LC-MS/MS方法的精密度、准确度和线性，并对方法的回收率、干扰和携带进行了评估。所有19个分析物的线性检查显示斜率在0.94到1.04之间，R-2总是大于0.99。4个不同水平的QC批间变异系数为1.1%~10%，其中LLOQ的变异系数为12%~12.8%，ULOQ的变异系数为0.8%~5.1%。我们的方法与GC-MS与患者标本的符合率为80.8%~100%。对DUS标本的稳定性进行了30天的评估，测量的浓度范围为100 ng/mL尿液校准剂的94%到114%。结论：我们建立并验证了一种符合FDA、CLSI和SAMHSA指南的DUS-LC-MS/MS方法，该方法具有高灵敏度和高特异性，为放射免疫分析提供了一种替代诊断工具，也为标本的运输、保存和储存提供了更好的解决方案。我们的方法在减少周转时间和测试成本方面的好处是显而易见的，这导致了更好的患者护理。(C)2013年加拿大临床化学家学会。爱思唯尔公司出版，版权所有。
Background: The lack of specificity of immunoassays for drugs of abuse testing (DAT), and concerns over its cost in conjunction with reflex confirmatory tests prompted us to investigate the combinatorial use of dried urine spot (DUS) and LC-MS/MS as an alternative.Methods: The method development and validation were performed in accordance with the guidelines published by FDA and CLSI.Results: In this study we established and validated the precision, accuracy, and linearity of our DUS-LC-MS/MS method, and assessed the recovery, interference, and carryover as well. The linearity check for all 19 analytes demonstrated slopes between 0.94 and 1.04, and R-2 always greater than 0.99. Between-batch CV for QC at 4 difference levels ranged from 1.1% to 10%, where CV of LLOQranged from 12% to 12.8% and CV of ULOQranged from 0.8%,to 5.1%. A concordance study with patient specimens between our method and GC-MS demonstrated 80.8% to 100% agreement. Stability of DUS specimens was assessed up to 30 days and the measured concentrations ranged from 94% to 114% of the 100 ng/mL urine calibrator used for this assessment.Conclusions: We established and validated a DUS-LC-MS/MS method for DAT that conforms to the guidelines dictated by FDA, CLSI, and SAMHSA While our method with high sensitivity and specificity provides an alternative diagnostic utility to EMIT immunoassays, it also offers superior solutions in specimen transportation, preservation, and storage. The benefits of our method are apparent in reducing turnaround time and test costs that result in better patient care. (C) 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.