Microfluidic immunoassay as a polysubstance oral fluid screening tool for law enforcement to rapidly identify recent drug use in traffic stops to reduce traffic fatalities and injuries.

Abstract More Americans are driving under the influence of drugs (DUID) than ever before, leading to an increase in fatal motor

vehicle accidents. With more than 12 million drivers DUID each year, only a fraction of law enforcement officers (8%) has

the advanced training needed to recognize drug impairment in roadside traffic stops, representing about 220 drivers DUID

for every patrol officer with advanced training. Like the breathalyzer for alcohol, presumptive drug screening technology can aid patrol officers in making standardized and objective decisions for DUID arrest. However, current drug screening

tests are primarily based on immunochromatographic test strips, and, as a result, yield merely qualitative results with poor

diagnostic performance and offer limited drug test menus that are missing high-priority drugs like fentanyl. There is an

unmet need for drug screening technology with performance characteristics like laboratory tests and the ability to measure multiple high-priority drugs, including fentanyl. Toward this goal, Portable Diagnostic Systems is developing a next-

generation microfluidics-based drug screening tool called the Integrity-1 Analysis System. The Integrity-1 Analysis System detects low abundance targets in small volumes (<20 𝜇L) of oral fluid with high accuracy and precision, made possible by

the novel microfluidic circulation of fluids over the sensors. When fully developed, the system will feature best-in-class portability, unparalleled multiplexing capability for more comprehensive drug screening, and analytical characteristics

closer to laboratory-based instrumentation. Our primary objective for this Phase I program is to establish the feasibility of

the Integrity-1 Analysis System for use in drug screening applications. First, we will develop the infrastructure for drug

testing, which involves fabricating test cartridges and reader prototypes to complete the project’s Aims. We will then develop a multiplexed assay of multiple drugs and/or drug metabolites of high interest to DUID enforcement as well as

clinical toxicology applications, including fentanyl. This work will culminate in a cross-sectional diagnostic accuracy study

of 100 subjects from a population with a high prevalence of drug use. The analysis will compare the diagnostic performance

(sensitivity and specificity) of the Integrity-1 relative to a commercially available oral fluid ICS test, verified by LC-MS as

the reference method. The results of this study will advance our technology toward the goal of developing an initial product for law enforcement under FDA regulatory discretion, and towards future regulated (510[k] clearance) IVD products in clinical toxicology and related applications. Our technology, when adopted for DUID enforcement, could help prevent

motor vehicle-related injuries and fatalities, which is consistent with CDC’s high-level strategic goals to protect America

from health, safety, and security threats. While not all persons DUID have substance use disorders (SUD), increasing the

yield of DUID convictions could also lead to earlier intervention for individuals at risk of SUD through addiction treatment

in the drug court system. In addition, near real-time data, facilitated by this technology, could act as surveillance systems to monitor national trends regarding the population incidence rate of DUID and the types/classes of drugs encountered.