The United States is in the midst of a prescription opioid epidemic. Deaths from misuse (51 daily) exceed deaths from heroin overdose and account for nearly one-fifth of all drug-related deaths. The estimated burden on the US healthcare system was $9.5 billion in 2005 and increased to an estimated $72.5 billion annually in 2014. A key recommendation of several federal agencies is to use urine drug testing (UDT) before prescribing opioids to establish overdosing (above expected levels of opioids in urine) or misuse with intent to resell (low or absent opioids despite patient claims to the contrary). Current strategy for UDT involves a qualitative screening immunoassay, followed by quantification using HPLC or GC/MS for positive cases. Screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians who do not have access to in-house testing have to send out patient samples for screening. Thus, laboratory testing of every patient suffering from chronic pain at every visit imposes unacceptable delays to treatment and is not followed by most physicians. A quick, affordable, layman operable, point of care UDT in the physician's office will help in rapid diagnosis of problems and potentially halt the epidemic. BreviTest Technologies has developed a low-cost, portable analyzer to perform a rapid, quantitative ELISA test within a 10-minute run time. The sample is loaded into a cartridge that is placed in the analyzer, and a robotic mechanism controls the movement of antibody-conjugated magnetic nanoparticles through successive fluid wells, where enhanced mixing patterns substantially reduce the time required for each ELISA step. This innovative approach enables the implementation of a rapid, portable, fully automated ELISA test with accuracy comparable to a standard laboratory ELISA. In this SBIR Phase I project, BreviTest will develop and optimize an ELISA test for opioids in urine using the BreviTest robotic analyzer.
The Specific Aims for the project are: (1) Develop a competitive ELISA for opioids using the BreviTest analyzer platform. We will determine the optimal reagent concentrations for the immunoassay and characterize performance of the assay in the BreviTest platform. Performance parameters will include dynamic range, repeatability, and limit of quantification. (2) Perform a limited proof-of- concept field study of the analyzer on de-identified urine samples in collaboration with a local pathology laboratory. BreviTest offers a unique platform to create an ELISA test for performing rapid quantifications of urine drug levels at the physician's office, which will be an invaluable tool to render more effective dosing to patients, paving the way towards lower toxicity and a better quality of life.
. Deaths from prescription opioids account for nearly one-fifth of all drug-related deaths in the US (51 deaths daily), through overdosing and misuse. Federal health agencies, aware of this growing epidemic, have advocated frequent urinary drug testing prior to prescriptions; however, physician compliance is poor because of the additional wait period for laboratory results. In this SBIR Phase I project, BreviTest Technologies proposes to develop, optimize, and conduct proof-of-concept studies for an affordable and quick urinary opioid assay that can be used by physicians in their offices for objective, accurate assessments prior to prescribing opioids.
