VALIDITY STUTIES OF COMMERCIAL DRUG SCREENING ASSAYS

检测滥用药物尿液变化的商业检测方法 定期，并且必须重新评估其性能。研究结果是 用临床标本测试新检测方法的有效性 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与了 这些研究。获得知情同意，并且所有程序都是 由医院机构审查委员会批准。商业化验 用于检测尿液中滥用药物的有效性 在受控剂量条件下收集的标本。各种各样的 研究了不同剂量水平的滥用药物。评选结果 将检测结果与GC/MS分析结果进行比较。 在最近的研究中，尿液中检测到大麻素的时间是 以20、50和100 ng/毫升为截止值的大麻素免疫测定法 通过GC/MS，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 成瘾研究中心的沃德。对每个尿样进行了分析。 在盲目的条件下，根据制造商的 指示。评估了下列大麻素试剂的排放( D.A.U。100，排放达标量。50，排放DAU。20，排放II 100，排放II 50， Abus creen Online、Abus creen RIA、DRI和ADX。所有的尿样都是 还用GC/MS分析了THCCOOH，截止值为15 ng/mL。尿液 大麻素检测时间在不同的化验方法、受试者、 剂量和截止水平。检测时间比以前更短 假设如此。平均检测时间从最多半天增加 小剂量用后一天半，大剂量用100 纳克/毫升截止值。平均检测时间不到一天后 低剂量且在高剂量暴露后不到两天 50 ng/m L为临界值。平均检测时间为1至5天 小剂量和大剂量后三至六天内用20 Ng/m L截止免疫法。GC/MS检测时间约为原来的两倍 只要免疫测定法的平均检测时间截止为50 ng/m L。 敏感度和特异度的差异 免疫分析产品影响大麻检测效率 使用。这些结果表明，最近大麻素截止量的减少 由军方和联邦授权的计划将增加检测时间 并如预期的那样提高敏感度。然而，监测急性大麻 使用截止浓度为50 ng/ml的商用大麻素免疫分析方法 浓度只能提供一到两个窄的检测窗口 几天。

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.