The overall aim of this SBIR program is to develop a surface-enhanced Raman spectroscopy (SERS) based device for on-site analysis of drugs in saliva. This device will allow immediate assessment of both medicinal and illicit drug use by patients with substance-related disorders (SRDs), and provide medical professionals and management with quantitative data so that treatment decisions can be made. Successful treatments for SRD patients require frequent monitoring of both medicinal and illicit drug use, which are mostly done in outpatient settings (doctor's office, rehabilitation centers, etc.) employing urine- based drug tests. For such tests, a sample is screened with immunoassay test kits, and if a drug is present, it is confirmed and quantified by gas chromatography - mass spectrometry (GC-MS). Unfortunately, immunoassay test kits are susceptible to false positives, while the GC-MS method is time consuming and requires highly trained operators and a laboratory setting. Consequently, there is a critical need for a device that combines the portability, speed and ease-of-use of immunoassay kits with the identification and quantitation abilities of GC-MS so that health care personnel can assess SRD patient compliance in outpatient settings. The proposed SERS Saliva Analyzer (SSA) will meet all such requirements by providing health care personnel an easy-to-use device, which will extract, identify and quantify the presence of drugs (and metabolites) at requisite levels in saliva (1-50 ng/mL), within 10 minutes. The overall aim of the Phase I program is to demonstrate feasibility by detecting two priority drugs (cocaine and diazepam) in saliva at physiologically relevant concentrations and analysis time. This will be accomplished by 1) measuring cocaine and diazepam at required sensitivity, and 2) measuring cocaine and diazepam in saliva. PUBLIC HEALTH RELEVANCE: The overall aim of this SBIR program is to develop a surface-enhanced Raman spectroscopy (SERS) based device for on-site analysis of drugs in saliva. This device will allow immediate assessment of both medicinal and illicit drug use by patients with substance-related disorders (SRDs), and provide medical professionals and management with quantitative data so that treatment decisions can be made.