SBIR-STTR Award

This research project is designed to investigate the feasibility to use saliva as an alternative biological fluid for the quantitative measurement of drugs of abuse. Collection of specimen is based on a patented device for the collection of an ultrafiltrate of saliva within a few minutes. As a non-invasive method, saliva can be unobtrusively obtained on-site without invasion of privacy and the risk of sample tampering. Once feasibility is proven, the saliva collection device could substitute for the controversial collection of urine, and allow sampling for subsequent screening (e.g. roadside testing of drivers of vehicles, military, sensitive jobs). The use of saliva collection device for the detection of one of the most frequently abused drugs, cocaine, and its major metabolites, benzoylecgonine, will be investigated as a model system in Phase I. The unimpaired transfer of drugs from saliva into the device, potential non- specific uptake, and the stability of drugs will be studied. Finally, the concentrations of cocaine and benzoylecgonine in urine, blood, and saliva from patients attending a drug rehabilitation program will be correlated. During Phase II, the application of the collection device will be extended to other drugs of abuse and applied in connection with a colorimetric immunoassay system that can be utilized on-site by untrained personnel and under non-laboratory conditions

This research project is designed to investigate the role of saliva as an alternative biological fluid for the quantitative measurement of cocaine and its metabolites. Specimen collection is based on an osmotic device for the collection of an ultrafiltrate of saliva in the mouth. The studies will provide a model for investigations of other drugs of abuse in an ultraflitrate of saliva. Preliminary results obtained in Phase I demonstrated the feasibility of screening for cocaine and its metabolite, benzoylecgonine, in saliva if the drug was ingested within 24 hours of sample collection. During Phase II, sample collection will be expanded to determine how long cocaine use can be detected using an ultrafiltrate of saliva. At the same time, analytical methods will be developed that focus on the lower concentration of analytes and the relatively small sample volume available with saliva as sample medium. These methods will include immunochemical screening procedures and confirmatory analysis by GC/MS or LC/MS. We will investigate whether the ratio of different cocaine metabolites in saliva can be used to obtain additional information about the time of drug ingestion. The refined analytical methods will be used to make an attempt to suggest threshold levels in saliva to determine recent use. The established criteria will be tested in a mixed population of drug users and non-users by comparing urinary concentrations of cocaine and benzoylecgonine with those in saliva.Awardee's statement of the potential commercial applications of the research:Saliva as biological medium for screening of drugs of abuse has a good potential for replacing the controversial collection of urine. With the patented device, non-invasive, unobtrusive, fast, hygienic collection of an ultrafiltrate of saliva opens up new opportunities for sampling and subsequent screening for drugs of abuse, i. e. roadside testing of drivers of vehicles by law enforcement agencies and on-site sampling without interrupting tasks currently being performed (e. g. armed forces, air traffic controllers).National Institute on Drug Abuse (NIDA)