VALIDITY STUDIES OF COMMERCIAL DRUG SCREENING ASSAYS

商业药物筛选试验的有效性研究

• 批准号: 3838558
• 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/3838558
• 关键词: diagnosis quality /standard; dosage; drug abuse; drug detection; evaluation /testing; gas chromatography mass spectrometry; human subject; male; substance abuse related disorder; urinalysis

Commercial assays for the detection of drugs of abuse in urine change periodically and must be reevaluated for validity of detection. Studies are designed to test the validity of new assays on clinical specimens obtained from drug users under controlled conditions. Healthy male volunteers with a history of chemical substance abuse participate in these studies. Informed consent is obtained and all procedures are approved by the Hospital Institutional Review Board. Commercial assays for detection of drugs of abuse in urine are tested for validity with specimens collected under controlled dosing conditions. A variety of drugs of abuse are studied at various dose levels. The results of the assays are compared to GC/MS analyses. These studies test the validity of commercial assays on clinical samples instead of "spiked" samples and provide uniques and valuable information to the military and industry concerning their time course of detection, specificity and accuracy.

用于检测尿液变化中滥用药物的商业测定法 定期进行，必须重新评估检测的有效性。 研究 旨在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。 有化学物质滥用史的健康男性志愿者 参与这些研究。 获得知情同意，所有 程序由医院机构审查委员会批准。 用于检测尿液中滥用药物的商业测定法被测试为 在受控给药条件下采集的样本的有效性。 一 对各种剂量水平的滥用药物进行了研究。 结果 的分析进行了比较，GC/MS分析。 这些研究测试了商业检测试剂盒对临床样本的有效性 而不是“加标”样品，并提供独特和有价值的信息， 军事和工业关于他们的时间进程的检测， 特异性和准确性。