Stout Peter R, Klette Kevin L, Wiegand Russell
Aegis Sciences Corp., 345 Hill Avenue, Nashville, Tennessee 37210, USA.
J Anal Toxicol. 2003 Jul-Aug;27(5):265-9. doi: 10.1093/jat/27.5.265.
The performances of four immunoassays (DRI amphetamines, DRI ecstasy, Abuscreen ONLINE amphetamines, and a modified Abuscreen ONLINE amphetamines) were evaluated for control failure rates, sensitivity, and specificity for amphetamine (AMP), methamphetamine (MTH), 3,4-methylenedioxyamphetamine (MDA), and 3,4-methylenedioxymethamphetamine (MDMA). The two DRI reagents and the ONLINE reagents were run according to manufacturer specifications using a Roche Hitachi Modular DDP system. The modified ONLINE reagent was calibrated with MDMA and had 16mM sodium periodate added to the R2 reagent. These assays were run on approximately 27,500 human urine samples and 7000 control urine samples prepared at 350 and 674 ng/mL over the course of 8 days. All assays were calibrated using a single point, qualitative cutoff standard with the manufacturer-recommended compound at the Department of Defense cutoff (500 ng/mL). Gas chromatography-mass spectrometry (GC-MS) confirmation was conducted on screened-positive samples. Control performance for the manufacturer recommended assays was excellent, with a maximum qualitative control failure rate of 2.03%. The modified ONLINE reagent demonstrated poor control performance with a maximum failure rate of 38.3% and showed no improved MDMA sensitivity when compared with the ONLINE reagent; the confirmation rate (20%) was improved when compared with the production ONLINE reagent (8%). The DRI ecstasy reagent provided improved sensitivity for MDMA as compared with the ONLINE reagent, with approximately 23% more samples screening and confirming positive for MDMA and a confirmation rate of approximately 90%. The DRI methamphetamine reagent had a low confirmation rate (6% or less) and produced numerous positives for samples with only ephedrine or pseudoephedrine present.
评估了四种免疫测定法（DRI苯丙胺、DRI摇头丸、Abuscreen ONLINE苯丙胺以及改良的Abuscreen ONLINE苯丙胺）对苯丙胺（AMP）、甲基苯丙胺（MTH）、3,4-亚甲基二氧基苯丙胺（MDA）和3,4-亚甲基二氧基甲基苯丙胺（MDMA）的控制失败率、灵敏度和特异性。两种DRI试剂和ONLINE试剂按照制造商规格，使用罗氏日立模块化DDP系统进行检测。改良的ONLINE试剂用MDMA校准，并在R2试剂中添加了16mM高碘酸钠。这些检测在8天内对约27500份人类尿液样本和7000份分别制备为350和674 ng/mL的对照尿液样本进行。所有检测均使用单点定性截断标准，以国防部截断值（500 ng/mL）的制造商推荐化合物进行校准。对筛查呈阳性的样本进行气相色谱-质谱（GC-MS）确证。制造商推荐检测的对照性能极佳，最大定性控制失败率为2.03%。改良的ONLINE试剂显示出较差的对照性能，最大失败率为38.3%，与ONLINE试剂相比，MDMA灵敏度未提高；与生产的ONLINE试剂（8%）相比，确证率（20%）有所提高。与ONLINE试剂相比，DRI摇头丸试剂对MDMA的灵敏度有所提高，筛查并确证为MDMA阳性的样本多约23%，确证率约为90%。DRI甲基苯丙胺试剂的确证率较低（6%或更低），对于仅含有麻黄碱或伪麻黄碱的样本产生了大量阳性结果。
