Barnes Allan J, Kim Insook, Schepers Raf, Moolchan Eric T, Wilson Lisa, Cooper Gail, Reid Claire, Hand Chris, Huestis Marilyn A
Chemistry and Drug Metabolism, Intramural Research Program, National Institute on Drug Abuse, National Institutes of Health, Baltimore, Maryland 21124, USA.
J Anal Toxicol. 2003 Oct;27(7):402-7. doi: 10.1093/jat/27.7.402.
Oral fluid specimens (N = 1406) were collected from 19 subjects prior to and up to 72 h following controlled administration of oral codeine. Volunteers provided informed consent to participate in this National Institute on Drug Abuse Institutional Review Board-approved protocol. A modification of Cozart Microplate Opiate EIA Oral Fluid Kit (Opiate ELISA), employing codeine calibrators, was used for semiquantitative analysis of opiates, followed by gas chromatography-mass spectrometry (GC-MS) for the confirmation and quantitation of codeine, norcodeine, morphine, and normorphine in oral fluid. GC-MS limits of detection and quantitation were 2.5 microg/L for all analytes. The Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed a 40-microg/L opiate screening and a 40-microg/L morphine or codeine confirmation cutoff for the detection of opiate use. Oral fluid opiate screening and confirmation cutoffs of 30 micro g/L are in use in the U.K. Utilizing 2.5-, 20-, 30-, and 40-microg/L GC-MS cutoffs, 26%, 20%, 19%, and 18% of the oral fluid specimens were positive for codeine or one of its metabolites. Six Opiate ELISA/confirmation cutoff criteria (2.5/2.5, 10/2.5, 20/20, 30/20, 30/30, and 40/40 microg/L) were evaluated. Calculations for Opiate ELISA sensitivity, specificity, and efficiency were determined from the number of true-positive, true-negative, false-positive, and false-negative results at each screening/confirmation cutoff. Sensitivity, specificity, and efficiency for the lowest cutoff were 91.5%, 88.6%, and 89.3%. Application of the cutoff currently used in the U.K. yielded sensitivity, specificity, and efficiency results of 79.7%, 99.0%, and 95.4% and similar results of 76.7%, 99.1%, and 95.1% when applying the SAMHSA criteria. These data indicate that the Opiate ELISA efficiently detects oral codeine use. In addition, the data, collected following controlled oral codeine administration, may aid in the interpretation of opiate oral fluid test results and in the selection of appropriate oral fluid screening and confirmation cutoffs.
在口服可待因的受控给药之前及之后长达72小时，从19名受试者身上采集了口腔液样本（N = 1406）。志愿者已提供知情同意书，以参与这项经美国国家药物滥用研究所机构审查委员会批准的方案。采用可待因校准品对Cozart微孔板阿片类物质酶免疫分析口腔液试剂盒（阿片类物质酶联免疫吸附测定法）进行改良，用于阿片类物质的半定量分析，随后采用气相色谱 - 质谱联用（GC-MS）对口腔液中的可待因、去甲可待因、吗啡和去甲吗啡进行确证和定量。所有分析物的GC-MS检测限和定量限均为2.5微克/升。物质滥用和精神健康服务管理局（SAMHSA）提议将40微克/升作为阿片类物质筛查的临界值，将40微克/升作为吗啡或可待因确证的临界值，用于检测阿片类物质的使用情况。英国使用的口腔液阿片类物质筛查和确证临界值为30微克/升。利用2.5、20、30和40微克/升的GC-MS临界值时，26%、20%、19%和18%的口腔液样本对可待因或其代谢物之一呈阳性。评估了六种阿片类物质酶联免疫吸附测定法/确证临界值标准（2.5/2.5、10/2.5、20/20、30/20、30/30和40/40微克/升）。根据每个筛查/确证临界值下的真阳性、真阴性、假阳性和假阴性结果数量，计算阿片类物质酶联免疫吸附测定法的灵敏度、特异性和效率。最低临界值的灵敏度、特异性和效率分别为91.5%、88.6%和89.3%。应用英国目前使用的临界值时，灵敏度、特异性和效率结果分别为79.7%、99.0%和95.4%；应用SAMHSA标准时，结果相似，分别为76.7%、99.1%和95.1%。这些数据表明，阿片类物质酶联免疫吸附测定法能有效检测口服可待因的使用情况。此外，在口服可待因的受控给药后收集的数据，可能有助于解释阿片类物质口腔液检测结果，并有助于选择合适的口腔液筛查和确证临界值。
