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药物检测方法及检测结果的临床解读。

Drug-testing methods and clinical interpretations of test results.

作者信息

Kapur B M

机构信息

Addiction Research Foundation, Toronto, Ontario, Canada.

出版信息

Bull Narc. 1993;45(2):115-54.

PMID:7920539
Abstract

In the present paper, major issues related to drug testing are discussed. For example, drug-testing techniques measure the presence of a drug or drugs but are not sophisticated enough to measure impairment from drug use. Moreover, it is difficult to determine the route of drug administration, quantity or frequency, as well as when the drug was taken, on the basis of the laboratory results. Selection of the drug to be tested should depend on the local availability of the drug, its abuse potential and clinical effects, as well as on the availability of analytical technology and expertise in testing and in interpreting laboratory results. The most sophisticated drug-testing approach is gas chromatography coupled with mass spectrometry (GC/MS), which is regarded as a "gold standard"; it is used in confirmatory testing. Typically, GC/MS is preceded by a rapid immunoassay method to eliminate the majority of the "negative" samples. Despite the existence of sophisticated drug-testing methods, it is still possible to obtain incorrect test results. Such results may be caused by the presence of interfering substances or adulteration of the urine sample. A number of techniques can be employed to reduce the likelihood of obtaining erroneous results and to detect adulterated urine samples. A "positive" drug finding can have a serious impact on the livelihood of an individual, therefore, persons conducting such tests should adhere to the strictest standards of laboratory performance. Only qualified and experienced individuals with proper laboratory equipment should perform these analyses. The standards of laboratory performance must meet local legal and forensic requirements. Access to patient samples and laboratory records must be restricted in order to prevent the tampering of samples and results. In order to maintain confidentiality, the results must be communicated only to the medical review officer. Chain-of-custody documents and all file so that they can be examined in case of a legal challenge. The laboratory must have a complete record on quality control. Finally, specific initial and confirmatory testing requirements should be met.

摘要

在本论文中,讨论了与药物检测相关的主要问题。例如,药物检测技术可检测一种或多种药物的存在,但不够精密,无法检测药物使用造成的损害。此外,根据实验室结果很难确定药物的给药途径、数量或频率,以及服药时间。待检测药物的选择应取决于该药物在当地的可得性、其滥用潜力和临床效果,以及分析技术的可得性和检测及解读实验室结果方面的专业知识。最精密的药物检测方法是气相色谱-质谱联用(GC/MS),它被视为“金标准”,用于确证检测。通常,在进行GC/MS检测之前,先用快速免疫分析方法排除大多数“阴性”样本。尽管存在精密的药物检测方法,但仍有可能获得错误的检测结果。此类结果可能是由于存在干扰物质或尿液样本被掺假所致。可以采用多种技术来降低获得错误结果的可能性,并检测掺假的尿液样本。药物检测呈“阳性”会对个人的生计产生严重影响,因此,进行此类检测的人员应遵守最严格的实验室操作标准。只有具备合格资质和经验且配备适当实验室设备的人员才能进行这些分析。实验室操作标准必须符合当地法律和法医要求。必须限制对患者样本和实验室记录的访问,以防止样本和结果被篡改。为了保密,结果只能传达给医学审查官。必须保留监管链文件和所有档案,以便在面临法律质疑时能够进行审查。实验室必须有完整的质量控制记录。最后,应满足特定的初始检测和确证检测要求。

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