BREVITEST TECHNOLOGIES, INC. — Department of Health and Human Services SBIR Phase I: R43

Description

DESCRIPTION provided by applicant Law enforcement officials workplace drug testing programs and researchers in the field of drug abuse lack rapid easily deployable tools to measure present cannabis marijuana intoxication The enzyme linked immunosorbant assay ELISA is an established cannabis testing method for detecting delta tetrahydrocannabinol THC levels in urine or blood however the logistics of obtaining urine or blood samples on site represents a major limitation of current THC ELISAs particularly for curbside testing of drivers The most feasible candidate sample for curbside testing is the oral fluid as it is a minimally invasive sampling route and the pharmacokinetics of THC concentration in oral fluid half life of hours parallels that of serum however the primary obstacle to this approach is the lack of a rapid quantitative THC immunoassay Traditional plate based ELISA tests can take to hours and require a laboratory setting and lateral flow assays lack the accuracy needed for quantitative cannabis intoxication detection BreviTest Technologies LLC is developing a portable analyzer to perform a rapid quantitative ELISA test within a minute run time The sample is loaded into a discontinuous microfluidics cartridge 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 partner with Cayman Chemical Company to develop a THC ELISA test using the BreviTest robotic analyzer with the following Specific Aims Develop and produce discontinuous microfluidic cartridges with layman operable sample port The type and quantity of magnetic nanoparticles will be determined for optimal reagent mixing and transit parameters and the design and validation will be completed for a sampling tool for metering L of sample fluid Design of the cartridge will be optimized for stability consistency and compatibility with biological materials Develop curbside ELISA test to quantitatively measure THC in oral fluid BreviTest will collaborate with Cayman Chemical to screen commercially available clones to generate an optimized antibody for THC detection Antibodies will be conjugated to magnetic nanoparticles via streptavidin biotin linkages for use in the BreviTest analyzer Optimization of reagent concentrations and analyzer parameters will be performed along with statistical validation of dynamic range specificity and sensitivity The completion of these proof of concept studies will demonstrate the ability of the BreviTest portable ELISA analyzer to measure THC concentration in oral fluid samples at concentrations relevant to curbside intoxication analysis This work will lay the foundation for further Phase II studies including fied and clinical testing of a rapid THC intoxication assay and additional validation testing towards a defined k clearance by the FDA PUBLIC HEALTH RELEVANCE The objective is to develop a portable automated analyzer for onsite detection of cannabis marijuana intoxication using a saliva sample The portable analyzer is capable of running an immunoassay in under ten minutes with accuracy and sensitivity comparable to standard laboratory assays This innovative technology for detecting cannabis intoxication will have broad benefits in the areas of law enforcement workplace safety and the diagnosis and treatment of substance use disorders