title: Evaluation of four oral fluid devices (DDS®, Drugtest 5000®, Drugwipe 5+® and RapidSTAT®) for on-site monitoring drugged driving in comparison with UHPLC-MS/MS analysis.
abstract: 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.
authors.affiliation: Institute of Legal Medicine, Catholic University of Sacred Heart, L.go F. Vito, 1, Rome, Italy. sabina.stranorossi@gmail.com
authors.forename: Sabina
authors.initials: S
authors.lastname: Strano-Rossi
authors.forename: Erika
authors.initials: E
authors.lastname: Castrignanò
authors.forename: Luca
authors.initials: L
authors.lastname: Anzillotti
authors.forename: Giovanni
authors.initials: G
authors.lastname: Serpelloni
authors.forename: Roberto
authors.initials: R
authors.lastname: Mollica
authors.forename: Franco
authors.initials: F
authors.lastname: Tagliaro
authors.forename: Jennifer P
authors.initials: JP
authors.lastname: Pascali
authors.forename: Delfina
authors.initials: D
authors.lastname: di Stefano
authors.forename: Roberto
authors.initials: R
authors.lastname: Sgalla
authors.forename: Marcello
authors.initials: M
authors.lastname: Chiarotti
mesh_terms: D001334:Automobile Driving / Q000331:legislation & jurisprudence*; D002853:Chromatography, Liquid; D006801:Humans; D013058:Mass Spectrometry; D009294:Narcotics / Q000032:analysis*; D012463:Saliva / Q000737:chemistry*; D012680:Sensitivity and Specificity; D015813:Substance Abuse Detection / Q000295:instrumentation*
chemical_list: D009294:Narcotics