A comprehensive device integrating fentanyl test strips with sample preparation features for convenient and discreet fentanyl testing in high-risk environments

Project Summary The opioid crisis, fueled by fentanyl contamination, has escalated, with fentanyl involved in nearly 70% of overdose deaths in the U.S. in the past year [1-5]. This crisis stems from cheaply produced fentanyl being mixed into illegal drugs, including counterfeit pills. In 2022, the DEA found that 6 out of 10 fake prescription pills contained a potentially lethal dose offentanyl [16]. Fentanyl test strips (FTS) are an effective detection tool but are often difficult to use, especially in public or social settings. The current multi-step testing process is time-consuming and error-prone, discouraging use and increasing overdose risks [11]. This strains healthcare systems and impacts broader societal issues like productivity and crime rates. Recent research shows that people who inject drugs (PWID) with a positive FTS result were five times more likely to change their drug use behavior [13]. However, those who used FTS after drug consumption were 70% less likely to modify subsequent behavior, highlighting the need for a more accessible and user-friendly testing method. To address these challenges, TeaSun is developing a streamlined fentanyl testing device that enhances accessibility, speed, and ease of use. Our innovation integrates multiple testing steps-crushing, measuring, and assaying-into a single, convenient unit, setting it apart from existing solutions. This all-in-one approach significantly simplifies the testing process, making it more practical for use in urgent or public situations. By incorporating FTS directly into the device, we aim to improve their accessibility. We plan to reach this market through strategic partnerships with U.S. harm reduction organizations, which spend $460 million annually on harm reduction supplies. Our team, which includes experts in product development, harm reduction, and drug testing, is well-positioned to execute this plan. Our innovation combines several testing steps into a single device, protected by U.S. patent 11478788B1. The design also incorporates human-centered design principles and is informed by Social Cognitive Theory, which emphasizes peer influence in behavior change. By creating a device that can easily be adopted and shared among social networks, we expect to foster trust and widespread adoption. In Phase I, Specific Aim 1 will focus on developing the technical feasibility of the device by designing and building a prototype, ensuring ease of use with three-step, one-handed operation with accurate measuring. Following the development of the prototype, Specific Aim 2 will focus on commercial feasibility and usability. We will conduct focus groups with key stakeholders, including people who use drugs and harm reduction professionals, to assess the device's ease of use, comfort, and practicality. Feedback from these sessions will drive iterative refinements to the design, improving its user-friendliness. Specific Aim 3 will focus on scientific feasibility, testing the device's detection limit, sensitivity, and specificity using real-world samples. Overall, our project aims to develop a convenient drug checking device to improve FTS accessibility in high-risk settings.