Kim Seon Young, Kim Hyunjin, Park Yeongchun, Lim Jinsook, Kim Jimyung, Koo Sun Hoe, Kwon Gye Cheol
Department of Laboratory Medicine, Chungnam National University School of Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, 35015, Republic of Korea.
J Anal Toxicol. 2017 Jun 1;41(5):412-420. doi: 10.1093/jat/bkx014.
On-site drugs of abuse testing devices have undergone continuous improvement. We evaluated three devices with different designs: an automated reader, the Multi-Drug Screen Test Device with DxLINK (DxLINK; Innovacon, Alere, San Diego, USA) and two colorimetric immunoassays, the One Step Multi-Line Screen Panel with Integrated E-Z Split Key Cup II (E-Z Cup; Innovacon, Alere) and the One Step Multi-Drug Screen Panel card (Multi4 card; Alere, Abon Biopharm, Hangzhou, China). Eleven drugs [amphetamine, secobarbital, oxazepam, buprenorphine, benzoylecgonine, methylenedioxymethamphetamine (MDMA), 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC), methamphetamine, methadone, morphine and nortriptyline] were tested using the DxLINK and E-Z Cup. Four drugs (benzoylecgonine, THC, methamphetamine and morphine) were tested using the Multi4 card using control materials (Detectabuse Stat-Skreen; Biochemical Diagnostics, Edgewood, NY, USA). The concentrations (-50%, -25%, +25%, +50% and 3× cut-off values) of the control materials were confirmed by mass spectrometry. Concordance rates were calculated around cut-offs. All devices showed high overall agreement rates of >90% with a few exceptions: the DxLINK exhibited lower sensitivity for benzoylecgonine, methadone and nortriptyline (60% and 30%, 92% and 40%, and 96% and 60% sensitivity at +50% and +25% cut-off levels, respectively). The E-Z Cup exhibited lower sensitivity for oxazepam and nortriptyline (97% and 50%, and 97% and 40% sensitivity at +50% and +25% cut-off levels, respectively). We additionally evaluated test-band color by visual inspection using a standard color-scale card. When detailed color criteria for determination of positivity were applied for the E-Z Cup, using slightly less stringent criteria, oxazepam, buprenorphine, MDMA and nortriptyline showed increases in sensitivity from 70-80% to 90-100%, all with a specificity above 98%. Overall, all devices exhibited satisfactory performance at ±50% cut-off levels for commonly used drugs, with the exception of lower sensitivity for cocaine testing for DxLINK. Careful evaluation of devices and elaborate calibration of visual interpretation for determining positivity may help improve the performance of these devices.
现场滥用药物检测设备一直在不断改进。我们评估了三种设计不同的设备：一种自动读数器、带有DxLINK的多药物筛查测试设备（DxLINK；Innovacon，美国圣地亚哥的Alere公司）以及两种比色免疫测定法，即带有集成E-Z分离钥匙杯II的一步多线筛查面板（E-Z杯；Innovacon，Alere）和一步多药物筛查面板卡（Multi4卡；中国杭州的Alere公司和Abon生物制药公司）。使用DxLINK和E-Z杯对11种药物[苯丙胺、速可巴比妥、奥沙西泮、丁丙诺啡、苯甲酰爱康宁、亚甲基二氧甲基苯丙胺（摇头丸）、11-去甲-9-羧基-Δ9-四氢大麻酚（THC）、甲基苯丙胺、美沙酮、吗啡和去甲替林]进行了检测。使用对照材料（Detectabuse Stat-Skreen；美国纽约州埃奇伍德的生化诊断公司）通过Multi4卡对4种药物（苯甲酰爱康宁、THC、甲基苯丙胺和吗啡）进行了检测。通过质谱法确认了对照材料的浓度（-50%、-25%、+25%、+50%和3倍临界值）。计算了临界值附近的一致性率。所有设备总体一致性率均高于90%，但有少数例外：DxLINK对苯甲酰爱康宁、美沙酮和去甲替林的灵敏度较低（在+50%和+25%临界值水平时，灵敏度分别为60%和30%、92%和40%、96%和60%）。E-Z杯对奥沙西泮和去甲替林的灵敏度较低（在+50%和+25%临界值水平时，灵敏度分别为97%和50%、97%和40%）。我们还使用标准色标卡通过目视检查评估了测试带颜色。当对E-Z杯应用稍宽松的详细阳性判定颜色标准时，奥沙西泮、丁丙诺啡、摇头丸和去甲替林的灵敏度从70%-80%提高到了90%-100%，特异性均高于98%。总体而言，除DxLINK对可卡因检测的灵敏度较低外，所有设备在常用药物±50%临界值水平时均表现出令人满意的性能。仔细评估设备并精心校准目视判读以确定阳性结果可能有助于提高这些设备的性能。
