Institute of Legal Medicine, Catholic University of Sacred Heart, L.go F. Vito, 1, Rome, Italy.
Forensic Sci Int. 2012 Sep 10;221(1-3):70-6. doi: 10.1016/j.forsciint.2012.04.003. Epub 2012 May 1.
New Italian legislation on driving under the influence of drugs considers oral fluid (OF) as a possible alternative drug testing matrix. On this basis, the present research was carried out to evaluate the applicability of four commercial on-site OF drug screening devices, namely DDS(®), Drugtest 5000(®), Drugwipe 5+(®) and RapidSTAT(®), in a real operative context. Preliminarily trained police officers tested randomly stopped drivers with two different kits side-by-side during roadside patrols. A central laboratory confirmed on-site kits' results by UHPLC-MS/MS analysis of the saliva specimen remaining after the screening analysis. 1025 drivers were submitted to the OF tests: 11.6% were positive for cocaine and metabolites, 11.1% for THC, 6% for amphetamines and amphetamine-type designer drugs and 2.3% for ketamine. The sensitivities of the kits were 81% (RapidSTAT(®)), 82% (DDS(®)), 90% (Drugwipe 5+(®)) and 97% (Drugtest 5000(®)) for cocaine and 38% (DDS(®)), 47% (Drugwipe 5+(®)), 72% (RapidSTAT(®)) and 92% (Drugtest 5000(®)) for THC. Drugtest 5000 was the only kit showing an acceptable sensitivity for on-site application. Only Drugtest 5000(®) and RapidSTAT(®) could be evaluated for amphetamines and methamphetamines: Drugtest 5000(®) showed a sensitivity of 100% in the case of amphetamines and 86% for methamphetamines, while RapidSTAT(®) 90% and 76% respectively. Nowadays, ketamine is not included in the target analytes of any on-site devices, but it was systematically included in the UHPLC-MS/MS confirmatory analysis. To ensure adequate reliability, MS confirmation of on-site OF screening tests is anyway always necessary, due to the presence of a significant number of false positive results even when using the commercial kit with the best performance.
新的意大利毒品影响驾驶立法将口服液（OF）视为一种可能的替代药物检测基质。在此基础上，本研究旨在评估四种商业现场 OF 药物筛选设备的适用性，即 DDS(®)、Drugtest 5000(®)、Drugwipe 5+(®)和 RapidSTAT(®)，在实际操作环境中。经过初步培训的警察在路边巡逻时并排使用两种不同的试剂盒对随机拦下的司机进行测试。一个中央实验室通过对筛选分析后剩余唾液样本进行 UHPLC-MS/MS 分析，对现场试剂盒的结果进行了确认。1025 名司机接受了 OF 测试：11.6%可卡因及其代谢物阳性，11.1%THC 阳性，6%安非他命和安非他命类兴奋剂阳性，2.3%氯胺酮阳性。试剂盒的灵敏度分别为：可卡因 81%（RapidSTAT(®)）、82%（DDS(®)）、90%（Drugwipe 5+(®)）和 97%（Drugtest 5000(®)）；THC 为 38%（DDS(®)）、47%（Drugwipe 5+(®)）、72%（RapidSTAT(®)）和 92%（Drugtest 5000(®)）。Drugtest 5000 是唯一一种现场应用灵敏度可接受的试剂盒。只有 Drugtest 5000(®)和 RapidSTAT(®)可用于评估安非他命和苯丙胺：Drugtest 5000(®)对安非他命的灵敏度为 100%，对苯丙胺的灵敏度为 86%，而 RapidSTAT(®)分别为 90%和 76%。如今，氯胺酮并未列入任何现场设备的目标分析物，但它被系统地纳入了 UHPLC-MS/MS 确证分析中。由于即使使用性能最佳的商业试剂盒，也会出现大量假阳性结果，因此，现场 OF 筛选测试的 MS 确证无论如何都是确保足够可靠性所必需的。
