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High sensitive and specific Point of use lateral flow strip for on site test of cannabis intoxication
Phone: (303) 717-4518
Email: xichun.zhou@lifebioscience.com
Phone: (303) 717-4518
Email: huiyan@vitan-biotech.com
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
* Information listed above is at the time of submission. *