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用于测定苯二氮䓬类药物的CEDIA和EMIT II免疫分析方法的比较。

Comparison between the CEDIA and EMIT II immunoassays for the determination of benzodiazepines.

作者信息

Way B A, Walton K G, Koenig J W, Eveland B J, Scott M G

机构信息

Washington University School of Medicine, Department of Pathology, St. Louis, MO 63110, USA.

出版信息

Clin Chim Acta. 1998 Mar 9;271(1):1-9. doi: 10.1016/s0009-8981(97)00227-1.

Abstract

We evaluated a new, qualitative immunoassay for benzodiazepines in urine using CEDIA technology on the Hitachi 747 and compared its performance to an immunoassay using EMIT II methodology on the same instrument. A total of 500 urine samples received for routine drug screen analysis were prospectively examined for benzodiazepines by both methods. Samples producing positive results by either immunoassay method were analyzed by gas chromatography-mass spectrometry (GC-MS). Available medical records were reviewed for patients whose samples produced discrepant immunoassay results or that were positive in both immunoassays but negative by GC-MS. Samples that produced negative results in both immunoassays were not subjected to GC-MS analysis. Therefore, identification of an immunoassay result as a false negative only occurred when the sample produced a positive value in only one of the two immunoassays and was confirmed as positive by either GC-MS or medical record review. Following initial immunoassay screening and confirmation by GC-MS, a medical record review and reanalysis of GC-MS data was performed. After this in-depth analysis of the data, the CEDIA method produced 60 true-positives, 7 false positives and no false negatives. The EMIT II method produced 47 true positives, 1 fase positive and 13 false negatives. These differences appear to be due to the CEDIA assay being more sensitive for detection of lorazepam.

摘要

我们使用日立747上的CEDIA技术评估了一种用于检测尿液中苯二氮䓬类药物的新型定性免疫测定法,并将其性能与在同一仪器上使用EMIT II方法的免疫测定法进行了比较。总共500份接受常规药物筛查分析的尿液样本,通过两种方法对苯二氮䓬类药物进行了前瞻性检测。两种免疫测定法中任何一种产生阳性结果的样本,均通过气相色谱-质谱联用(GC-MS)进行分析。对样本产生免疫测定结果不一致或两种免疫测定均为阳性但GC-MS为阴性的患者的现有病历进行了审查。两种免疫测定均产生阴性结果的样本未进行GC-MS分析。因此,仅当样本在两种免疫测定中的一种中产生正值,并且通过GC-MS或病历审查确认为阳性时,免疫测定结果才被鉴定为假阴性。在最初的免疫测定筛查和GC-MS确认之后,进行了病历审查和GC-MS数据的重新分析。在对数据进行深入分析之后,CEDIA方法产生了60个真阳性、7个假阳性且无假阴性。EMIT II方法产生了47个真阳性、1个假阳性和13个假阴性。这些差异似乎是由于CEDIA测定法对劳拉西泮的检测更敏感。

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