Sensitive and Portable Physician Office-Based Urine Analyzer to Tackle Prescription Drug Abuse

PROJECT SUMMARY BreviTest Technologies, LLC, proposes to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for the assay platform to deliver quantitative performance similar to a standard laboratory ELISA. Phase I research and development showed the repeatability and accuracy of BreviTest’s proprietary assay technology. Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. Thus most physicians do not follow the federal recommendations to use urine drug testing (UDT) before prescribing opioids to identify potential opioid abuse, either from overdosing (above expected levels of opioids in urine) or intent to resell (low or absent opioids despite patient claims to the contrary). BreviTest Technologies has developed a low-cost, layman operable, POC analyzer to perform a quantitative ELISA test within a 10-minute run time. The sample is loaded into a cartridge that is placed in the analyzer and an automated mechanism controls the movement of antibody-conjugated magnetic microparticles through successive fluid wells with enhanced mixing patterns. This innovative approach enables the implementation of a rapid, portable, fully automated ELISA test with accuracy comparable to a standard laboratory ELISA. The Specific Aims for this Phase II project are: (1) Finalize development and implementation of repeatability and calibration protocols according to industry standards for the diagnostic device and disposable test cartridges; (2) Build and characterize fully integrated prototypes to obtain a finalized device design, packaging, process, and tooling; (3) Perform testing of finalized BreviTest device and performance validation using patient urine samples. The expected outcome of this project will be a device designed for manufacturing (DFM), built and characterized by a contract manufacturer, validated in a pilot study and user simulation, ready to enter design controls, and with a regulatory and commercialization path in place. BreviTest offers a unique platform to create an ELISA test for performing rapid quantifications of urine drug levels in a physician’s office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way towards lower toxicity and a better quality of life.PROJECT NARRATIVE. Deaths from prescription opioids account for nearly one-fifth of all drug-related deaths in the US (134 deaths daily), through overdosing and misuse. Federal health agencies, aware of this growing epidemic, have advocated urinary drug testing prior to prescriptions; however, physician compliance is poor because of the additional wait period for laboratory results. The proposed point-of-care diagnostic device will fill a critical unmet need for an affordable and quick urinary opioid test that can be used by physicians in their offices for objective, accurate assessments prior to prescribing opioids. The technology can potentially be used in pain clinics, private practice, public health laboratories, and urban emergency departments throughout the United States.