Application of programmable bio-nano-chip system for the quantitative detection of drugs of abuse in oral fluids

Abstract

Objective There is currently a gap in on-site drug of abuse monitoring. Current detection methods involve invasive sampling of blood and urine specimens, or collection of oral fluid, followed by qualitative screening tests using immunochromatographic cartridges. While remote laboratories then may provide confirmation and quantitative assessment of a presumptive positive, this instrumentation is expensive and decoupled from the initial sampling making the current drug-screening program inefficient and costly. The authors applied a noninvasive oral fluid sampling approach integrated with the in-development chip-based Programmable Bio-Nano-Chip (p-BNC) platform for the detection of drugs of abuse. Method The p-BNC assay methodology was applied for the detection of tetrahydrocannabinol, morphine, amphetamine, methamphetamine, cocaine, methadone and benzodiazepines, initially using spiked buffered samples and, ultimately, using oral fluid specimen collected from consented volunteers. Results Rapid (~10 minutes), sensitive detection (~ng/ml) and quantitation of 12 drugs of abuse was demonstrated on the p-BNC platform. Furthermore, the system provided visibility to time-course of select drug and metabolite profiles in oral fluids; for the drug cocaine, three regions of slope were observed that, when combined with concentration measurements from this and prior impairment studies, information about cocaine-induced impairment may be revealed. Conclusions This chip-based p-BNC detection modality has significant potential to be used in the future by law enforcement officers for roadside drug testing and to serve a variety of other settings, including outpatient and inpatient drug rehabilitation centers, emergency rooms, prisons, schools, and in the workplace.

Programmable bio-nano-chip system: a flexible point-of-care platform for bioscience and clinical measurements

“…As such, accuracy and reproducibility studies for a broad coverage of clinical applications on this new instrument is out of scope at this time and will be featured with greater focus in future publications. Previous work on the macro-scale system reports biomarker ranges and limits of detection for a variety of applications 42 as well as assay performance for specific applications such as drugs of abuse, 48 cardiac heart disease, 49 and ovarian cancer. 41 The new instrumentation here described yields comparable performance to prior lab-based equipment previously reported.…”

Next Generation Programmable Bio-Nano-Chip System for On-Site Quantitative Drug Detection in Oral Fluids

“…It should be noted, the majority of the initial development work on the chip-based drug detection already reported was completed using ‘macro’ laboratory prototypes, that included metal encased “flow cells” and bench-top instrumentation [12]. At the same time, parallel efforts have been directed toward the establishment of portable ‘micro’ instrumentation [13] and disposable labcards that now may be used at the point of need settings.…”

“…As we have described recently [12], the bead-based p-BNC drug tests function with non-invasive oral fluid sampling; more specifically, the process involves use of an oral swab to brush the entire upper and lower gum line, and then insertion of the swab into a specimen collection tube to extract the sample into the assay fluid that includes the tracer antibody used in bead/chip-based competitive immunoassay. The p-BNC reveals if there are specific drugs (i.e., drug immune-equivalents) present in the body within ~ 10 minutes.…”

“…Herein provided is an update on the further development of the bead-based Programmable Bio-Nano-Chip (p-BNC) drug tests we have recently reported [12]. ” It is expected that this next generation of a microfluidics point-of-care (POC) including a cartridge and miniaturized analyzer, will permit real-time screening of drug users in treatment facilities.…”

Innovative Programmable Bio-Nano-Chip Digitizes Biology Using Sensors That Learn Bridging Biomarker Discovery and Clinical Implementation

“…Analysis of each bead within the group, for each of the drug tests reported here, at each exposure time was initiated within the macro through line profile and circular area of interest routines for data extraction (46, 47). …”