High sensitive and specific Point of use lateral flow strip for on site test of cannabis intoxication

Project Summary Marijuana e g cannabis is the most frequently detected drug of abuse Cannabis abuse has a substantial impact on public safety as driving under the influence of cannabis will impair driving skill and the marijuana use in the workplace will increase the risk of adverse events and the loss of productivity With the recent wave of legalization of marijuana use in numerous states and the increase of use marijuana in re creation and medical treatment the US is experiencing a rise in cases of driving under influence of cannabis and workplace cannabis intoxication The lack of sensitive rapid easy to use and reliable tool for on site cannabinoid tests is a critical gap in the ability of Law enforcement officials workplace drug testing programs and researchers in the field of drug abuse to measure present cannabis intoxication The current established cannabis testing methods are either laboratory enzyme linked immunosorbent assay ELISA or GC MS for the detection of the cannabis metabolites in urine or blood which take to hours and require a laboratory setting however the logistics of obtaining urine or blood samples on site represents a major limitation of current methods We propose to develop a low cost disposable point of use highly sensitive and specific non instrument test strip that enables the convenient onsite detection of the cannabis intoxication in saliva The test requires no special training to operate and qualitative yes no and semi quantitative results are visibly obtained within ten minutes To circumvent the technical challenge of a lateral flow assay LFA strip s ability to measure low concentration of cannabis in saliva fluid e g sensitivity meets the cutoff concentration ng mL of marijuana intoxication we will implement innovative strip architecture and built in signal amplification by dual labeled Au nanoparticle conjugates into the strip to enhance the sensitivity To increase the specificity for cannabis detection we propose a new assay format by using peptide specific against the immunocomplex of cannabis capture antibody in the test line of the LFA We will optimize reagent concentrations and LFA parameters along with statistical validation of dynamic range specificity and sensitivity in Phase I project The completion of these proof of concept studies will demonstrate the ability of this new type LFA to measure cannabis concentration in saliva samples at concentrations relevant to roadside and workplace intoxication analysis In Phase II we will optimize the LFAs configuration to reduce false negatives and false positives to ensure reliable detection design and develop any associated devices cassette packaging and labeling develop smartphone based quantitative analysis of the LFA test results and data processing Apps recording and wireless communication of test results and develop manufacturing processes for pilot scale production of LFAs and validate the cannabis saliva test with a large cohort of saliva samples andgt clinical saliva samples At the end of Phase II the colorimetric LFAs will be ready for transferring to full scale automated manufacturing and final LFAs device will be produced at large scale for clinical validation towards a defined k clearance by the FDA Project Narrative Marijuana e g cannabis is the most frequently used illicit drug of abuse in the United States and abuse of cannabis also has a substantial impact on public safety With the recent wave of legalization of marijuana use in numerous states the US is experiencing a rise in cases of driving under influence of cannabis and workplace cannabis intoxication There is a critical need for a rapid onsite cannabis intoxication test for highway law enforcement and workplace drug testing programs If funded this proposed project will fill current technology void in developing a low cost point of use highly sensitive and specific non instrument test that enables the convenient onsite detection of the cannabis marijuana intoxication