REAL-TIME ANALYZERS INC — Department of Health and Human Services SBIR Phase II: NIDA

Description

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 doctorandapos 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 through ng mL within 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 to ng mL in 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 PUBLIC HEALTH RELEVANCE 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