Research Project
8916066
DESCRIPTION (provided by applicant): The overall aim of this SBIR program is to develop a surface-enhanced Raman spectroscopy (SERS) based device for point-of-care analysis of drugs in patient saliva. This device will allow immediate assessment of both prescription 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. The use of saliva will eliminate the chance of HIV infection associated with blood analysis for both patient and clinician. Successful treatments for SRD patients require frequent monitoring of both prescription and illicit drug use. Monitoring is mostly performed in outpatient settings (doctor's office, rehabilitation centers, etc.) employing urine samples and immunoassay test kits, which only provide qualitative information (yes/no). If a test is positive it is confirmed and quantified by gas chromatography coupled mass spectrometry (GC/MS), which often requires a blood sample. Unfortunately, immunoassay test kits are susceptible to false positives, while the GC/MS analysis is performed at clinical laboratories by highly trained operators, and results are usually not available for days. 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 Saliva Drug Analyzer (SDA) will meet all such requirements by providing health care personnel with an easy-to-use device, which will extract, identify and quantify the presence of drugs (and metabolites) at requisite levels in saliva (10 through 10,000 ng/mL), within 10 minutes. During the Phase I program feasibility was demonstrate by developing a material that both separates drugs from saliva and generates SERS, and detecting two priority drugs, cocaine and diazepam in saliva from 25 to 10,000 ng/mL in 15 minutes. The overall aim of the Phase II program will be to develop and validate an SDA prototype so that it is ready for Phase III clinical trials. This will be accomplished by building the prototype and measuring actual patient samples through a subcontract with the Yale School of Medicine in conjunction with the Veterans Affairs Medical Center (VAMC), West Haven, CT.
