An evaluation of on-site oral fluid drug screening devices drugwipe® 5+ and rapid STAT® using oral fluid for confirmation analysis

Abstract

In this study, the performance of two on-site oral fluid drug-testing devices, DrugWipe 5+ (Securetec) and Rapid STAT (Mavand), was assessed. The results obtained by the devices were compared with gas chromatography-mass spectrometry confirmation analysis results in oral fluid. Sensitivity, specificity, and accuracy of the tests, as well as positive and negative predictive values, were calculated based on the classified results of the comparison. Both of the devices were evaluated for their ability to meet toxicological cutoffs as set in the DRUID project (www.druid-project.eu) as well as those reported by the manufacturers. The evaluation was performed for relevant drug groups of both devices: amphetamines, cannabis, cocaine, and opiates. Additionally, Rapid STAT has a test for benzodiazepines included in the same device. Both tests seemed to perform quite well for amphetamines although they also gave negative results for cases with high concentrations. Also, the benzodiazepine test of Rapid STAT was at a relatively good level although only half of the positive test results were true positives using the test cutoffs. The same phenomenon was detected for the cannabis tests of both devices. The proper evaluation of cocaine and opiates tests was not applicable because of the very low number of positive cases.