VALIDITY STUTIES OF COMMERCIAL DRUG SCREENING ASSAYS

商业药物筛选试验的有效性研究

• 批准号: 2449746
• 负责人: E J CONE
• 金额: --
• 依托单位: NATIONAL INSTITUTE ON DRUG ABUSE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/2449746
• 关键词: Cannabis; clinical research; diagnosis design /evaluation; dosage; drug abuse; drug screening /evaluation; gas chromatography mass spectrometry; human subject; immunologic assay /test; inhalation drug abuse; male; performance; tobacco abuse; urinalysis

Commercial assays for the detection of drugs of abuse in urine change periodically and must be reevaluated for performance. Studies were designed to test the validity of new assays with clinical specimens obtained from drug users under controlled conditions. Healthy male volunteers with a history of chemical substance abuse participated in these studies. Informed consent is obtained and all procedures were approved by the hospital Institutional Review Board. Commercial assays for detection of drugs of abuse in urine were tested for validity with specimens collected under controlled dosing conditions. A variety of drugs of abuse were studied at various dose levels. The results of the assays were compared to GC/MS analysis. In the most recent study, detection times of cannabinoids in urine were measured with cannabinoid immunoassays at 20, 50 and 100 ng/mL cutoffs and with GC/MS. Six subjects smoked a single marijuana cigarette (placebo, 1.75% or 3.55% THC) each week while residing on the clinical ward of the Addiction Research Center. Each urine specimen was analyzed under blind conditions by immunoassay according to the manufacturer's instructions. The following cannabinoid reagents were evaluated Emit( d.a.u. 100, Emit d.a.u. 50, Emit d.a.u. 20, Emit II 100, Emit II 50, Abuscreen Online, Abuscreen RIA, DRI and ADx. All urine specimens were also analyzed for THCCOOH by GC/MS with a 15 ng/mL cutoff. Urinary cannabinoid detection times varied substantially across assays, subjects, doses, and cutoff levels. Detection times were shorter than previously assumed. Mean detection times increased from a maximum of one-half day after the low dose to a day and a half after the high dose with the 100 ng/mL cutoff. Mean detection times were less than one day following the low dose and less than two days following the high dose exposure with the 50 ng/mL cutoff. Mean detection times ranged from one to five days after the low dose and from three to six days after the high dose with the 20 ng/mL cutoff immunoassay. GC/MS detection times were approximately twice as long as mean detection times with an immunoassay cutoff of 50 ng/mL. Differences in sensitivity and specificity between the available immunoassay products affected the efficiency of detection of marijuana use. These results indicate that recent reductions in cannabinoid cutoffs by military and Federally-mandated programs will increase detection times and improve sensitivity, as expected. However, monitoring acute marijuana usage with a commercial cannabinoid immunoassay with a 50 ng/mL cutoff concentration provides only a narrow window of detection of one to two days.

用于检测尿液变化中滥用药物的商业测定法 定期进行，必须重新评估性能。 研究是 设计用于测试新检测试剂盒对临床标本的有效性 在受控条件下从吸毒者那里获得的。健康男性 有化学物质滥用史的志愿者参加了 这些研究。 获得知情同意书，所有程序均 经医院机构审查委员会批准。 商业测定法 用于检测尿液中滥用药物的有效性， 在受控给药条件下采集的样本。 各种 对不同剂量水平的滥用药物进行了研究。 的结果 将测定与GC/MS分析进行比较。 在最近的研究中，尿液中大麻素的检测时间为 用大麻素免疫测定法在20、50和100 ng/mL临界值下测量 6名受试者吸了一支大麻烟， （安慰剂，1.75%或3.55%THC），同时居住在临床 成瘾研究中心的病房 分析每份尿液标本 在盲法条件下，根据制造商的 指令对以下大麻素试剂进行了评价Emit（ d.a.u. 100，发射d.a.u. 50，Emit d.a.u. 20，发射II 100，发射II 50， Abuscreen Online、Abuscreen RIA、DRI和ADx。所有尿液样本均为 还通过GC/MS以15 ng/mL截止值分析THCCOOH。 尿 大麻素检测时间在不同的测定，受试者， 剂量和截止水平。 检测时间比以前短 假设。 平均检测时间从最多半天增加 低剂量后至高剂量后一天半， ng/mL临界值。平均检测时间少于一天后， 低剂量和高剂量暴露后不到两天， 50 ng/mL临界值。平均检测时间范围为一至五天后， 低剂量和高剂量后3至6天， ng/mL截止免疫测定。GC/MS检测时间约为 与平均检测时间一样长，免疫测定临界值为50 ng/mL。 可用的灵敏度和特异性之间的差异 免疫测定产品影响大麻的检测效率 使用.这些结果表明，最近大麻素截止值的减少 由军方和联邦授权的项目将增加检测时间 并提高灵敏度，正如预期的那样。然而，监测急性大麻 使用商业大麻素免疫测定法，50 ng/mL截止值 浓度仅提供一至两个的窄检测窗口， 天