Rositaii Evaluation of OnSite Oral Fluid Test in Europe and the United States

In 2003, a follow-up project to ROSITA was started. This time, the study is being performed in collaboration with the United States. Six European partner countries of the former ROSITA project (Belgium, Finland, France, Germany, Norway, and Spain) and five states in the United States—Utah (Salt Lake City Police), Florida (Hillsborough County Sheriff's Office and Manatee County Sheriff's Office, Washington (State Patrol), Wisconsin (State Laboratory of Hygiene), and Indiana (State Department of Toxicology/Indiana State Police)—are the participants. In this study, the focus is exclusively on oral-fluid testing. In total, approx 3000 subjects will be tested in two 9-mo testing periods, separated by a 3-mo interim evaluation period. A preliminary market study identified 10 on-site test devices appropriate for testing drugs in oral fluids (Table 7). Six of the 10 have been evaluated with spiked oral-fluid samples (Table 7). Final results are expected to be published by the end of 2005.

Based on the experience with the first ROSITA project, the focus of ROSITA II will be on a more uniform protocol with identical limits of detection for the reference methods. Initial evaluations indicate that the current versions of the oral-fluid test devices have made some progress, but not as much as was hoped for in 2000. In particular, the detection of THC is still problematic. Although a detection limit of of 2 ng/mL is necessary, the best device can detect 20 ng/mL only 50% of the time (Table 8).

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