AXCEND LLC — Department of Health and Human Services STTR Phase I: R41

Description

Project Summary Abstract Point of carePOCtesting of clinical samples for the presence of illegal substances and their metabolites is important for monitoring substance use disordersemployment screeningand legal matters relating to drug abstinenceTypical immunoassay screening methods suffer from higher false testing rates and do not provide quantitative informationConfirmatory tests that are used for quantitative analysis rely on chromatographic separations coupled with mass spectrometricMSdetectionwhich requires expensive instrumentation and technical expertise for operationIn this research projecta prototype liquid chromatographyLCinstrument with integrated LED UV detection will be developed for the purpose of POC screening of illicit drugs in clinical samplesThe system includes integrated separation column cartridgeswhich makes column installation much simpler than with traditional instrumentation that requires additional tubing and fittingsA control program that runs on a miniaturized computer with an integrated touch screen user interface is then used for instrument control and data acquisitionA method library for the separation of different classes of illicit substances will be developed on standard LC instrumentation using a variety of columns packed with different particle types and stationary phase selectivitiesThese methods will then be translated to the prototype system where users will be able to select a method for a given drug test panelwhich reduces the technical expertise required to obtain concentration data on the tested samplesWith this instrumentthe integrated column cartridge is designed for dual LED UV detection so that a single analyte is measured at two different absorbance wavelengths to provide positive identification using a new data analysis tool referred to as thedetection capacityThe absorbance ratio for a given peak provides qualitative identificationwhich will ensure that each analyte is accounted for individually during the separationPotential customers for this new products currently involved in the analysis of illicit substances will collaborate on the project to ensure that the results correlate well with the current methods employed for this applicationThe results generated by this new system will be faster and provide more analyte information that the standard immunoassay screening tests currently usedproviding an important new commercial tool for POC drug monitoring Project Narrative Point of care monitoring of illegal substance abuse typically relies on immunoassay based qualitative methods to analyze clinical samplesThis project focuses on the development of a portable liquid chromatography system with integrated user control software that can be used to perform point of care analyses of illicit drug concentrations in such samples with more information provided than these current screening methods