Abstract
Current on-site drug of abuse detection methods involve invasive sampling of blood and urine specimens, or collection of oral fluid, followed by qualitative screening tests using immunochromatographic cartridges. Test confirmation and quantitative assessment of a presumptive positive are then provided by remote laboratories, an inefficient and costly process decoupled from the initial sampling. Recently, a new noninvasive oral fluid sampling approach that is integrated with the chip-based Programmable Bio-Nano-Chip (p-BNC) platform has been developed for the rapid (~ 10 minutes), sensitive detection (~ ng/ml) and quantitation of 12 drugs of abuse. Furthermore, the system can provide the time-course of select drug and metabolite profiles in oral fluids. For cocaine, we observed three slope components were correlated with cocaine-induced impairment using this chipbased p-BNC detection modality. Thus, this p-BNC has significant potential for roadside drug testing by law enforcement officers. Initial work reported on chipbased drug detection was completed using ‘macro’ or “chip in the lab” prototypes, that included metal encased “flow cells”, external peristaltic pumps and a bench-top analyzer system instrumentation. We now describe the next generation miniaturized analyzer instrumentation along with customized disposables and sampling devices. These tools will offer real-time oral fluid drug monitoring capabilities, to be used for roadside drug testing as well as testing in clinical settings as a non-invasive, quantitative, accurate and sensitive tool to verify patient adherence to treatment.
Highlights
A key feature differentiates the Programmable Bio-Nano-Chip (p-BNC) from other analytical schemata
Oral fluid sample collected by a swab (Ai) is extracted in assay buffer (Aii), to be delivered to the microfluidic cell hosting bead sensors arrayed on a microchip
Unlike immunochromatographic test strips (ICS) tests, which are qualitative (Yes/No) type of tests, both LC–MS/MS and p-BNC-based drug tests are fully quantitative, albeit p-BNC tests are highly dependent on the specificity of the antibody reagents that they employ
Summary
Likewise, increasing emphasis on treatment outcomes as evidence of program effectiveness has added significance to drug tests in Treatment Programs (TPs), as well as use of drug test results in response to quality assurance requirements. Up to this juncture, drug testing in treatment settings has been limited to either remote drug testing via laboratoryconfined procedures (LC-MS/MS or ELISA) associated with long turn-around time for results reporting or on-site urine testing via immunochromatographic test strips (ICS), which are known to have limited multiplexing and semi-quantitative measurement capacities. Drug test results help policymakers and TP administrators detect and monitor emerging trends in substance abuse that may signal a need to redirect resources.
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