The Substance Abuse and Mental Health Services Administration (SAMHSA) has set guidelines for illicit drugmonitoring for both screening and confirmatory tests. Point-of-care (POC) screening assays usually rely uponimmunoassays that lack specificity among compounds in a given drug class. Confirmation testing usuallyemploys chromatography coupled to mass spectrometry (MS), which is a powerful technique capable ofidentifying the relevant analytes of interest in complex samples; however, this approach requires large,expensive equipment that requires technical expertise to operate, thus precluding it from POC environments. Inthis Fast-Track SBIR project, scientists at Axcend Corporation in collaboration with chromatography and druganalysis experts in academia and advice from practicing health care professionals will pursue furtherdevelopment of a compact capillary liquid chromatography (LC) platform for rapid POC screening of drugs ofabuse. In Phase I, sample preparation with a novel solid phase extraction (SPE) apparatus will be optimized andautomated, a longer pathlength UV absorption detector flow cell will be created, and capillary LC stationaryphases and mobile phases will be investigated and selected to achieve SAMHSA testing concentration cutofflimits for relevant compounds using the compact LC system. In Phase II, novel column-column and column-detector combinations, diode-array detection modules, and data processing approaches combiningchromatographic retention times and UV absorption ratios will be developed to enhance the analysis of thesecompounds and provide timely information to support urgent patient treatment decisions. Key aspects of thisproposal that are unique to advancing the field of POC chemical analysis using capillary LC are (1) improvedsensitivity using novel simple off-line and on-line extraction and concentration devices, and a longer pathlengthUV-absorption flow cell; (2) combinations of columns, solvents, and modes of operation for maximum LCseparation, and (3) enhanced selectivity of detection using innovative tandem column-UV-detectorcombinations, (4) a new compact DAD UV-absorption detector for capillary LC, and (5) unique data handlingsoftware algorithms for peak deconvolution. These innovations are new to the area of POC analysis as well asto the broad field of capillary LC in general. The results from this project will be a critical step towards the releaseof a POC drug screening solution that provides improved patient care compared to current healthcare practices.
Public Health Relevance Statement: Project Narrative
Monitoring of illicit drug use is a critical component of care in drug treatment facilities and pain clinics, as well as
in other situations where patients may be at risk of substance use disorders. This project focuses on improved
analytical methodologies to perform this type of testing in point-of-care settings by using a compact capillary
liquid chromatograph. The new approaches developed here will provide improvements to current point-of-care
screening assays by providing higher specificity, rapid turn-around, and the capability to look at multiple drug
classes with a single instrument.
Project Terms: |
