Summary
"The demand for a quick and simple roadside screening device for oral fluid is rapidly increasing. Commercially available oral fluid screening devices all operate similarly and are based on point of collection saliva testing combined with immunoassay detection of selected (illicit) drugs. Their applicability to roadside testing, however, requires consideration of a number of variables: ease of operation (sample collection, completion time and ease of result reading/interpretation), reliability, sensitivity, specificity and kit cost. Although the manufacturers test and provide abundant performance data, it is imperative that end-users conduct an objective validation of any device prior to implementing one or more into a standard operating procedure for roadside testing. Towards this goal, BCIT reviewed the currently available point-of-collection devices and chose three for validation under laboratory conditions (Oratec-II/III, OraLine-IV and Drugwipe-5/5+) based on the characteristics noted and proposed Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines. The five target drug classes tested were Cocaine, Amphetamines, Opiates, THC and Benzodiazepines. A low detection limit for THC was considered as a secondary selection criteria and eliminated many potential devices from the study. The devices were challenged with single drug formulations of known concentration by spiking into either pooled saliva or water prior to device testing. Overall, the testing of saliva-spiked samples performed less well compared to the water-spiked samples, although the latter precluded their additional testing on the Oraline-IV device. Each device showed instances of good and bad sensitivities and specificities depending on the medium and/or drug tested. The results of this project, taken in totality, do not point to a single point-of-collection device with superior performance characteristics but the technology in general holds promise for further testing and future roadside screening for drugs.