Development of a Colorimetric Sensor for Detection of Cerebrospinal Fluid Leaks

PROJECT SUMMARY Chemeleon is developing an easy to use colorimetric biosensorlike a pH test stripto aid doctors in eliminating uncertainty and delays in diagnosing cerebrospinal fluidCSFleakageThe product has applications in multiple clinical scenariosincluding traumatic brain injuriesTBIin emergency departmentsEDlumbar puncturesspontaneous CSF leak casesand during spinal surgeriesCSF leaks develop when there is a rupture in the membranes surrounding the brain or spinal cordWhile some CSF leaks occur spontaneouslymost are a result of a TBIpresenting as rhinorrheaor a result of spinal surgery in which the clear CSF fluid mixes with blood and other liquidsDiagnosing CSF leaks is a well known problem for neurosurgeonsas it is difficult to differentiate from common fluidsCurrentlypatient samples are sent out for third party analysistaking several days for results to returnDelayed treatment during this time increases patient morbidityas well as further complications such as meningitisbrain infectionsor strokeIn the case of spinal surgeriesa dural tear resulting in a CSF leak is a risk of spinal proceduresCurrently there is no accurateon site test to help neurosurgeons identify CSF leaks during surgeryThe innovation of the proposed approach lies in the integration of a synthetic nanoreceptorable to capture thetransferrin protein uniquely found in CSFwith a nanostructured surface capable of generating visible color changes upon capture of the targeted proteinThis product will give neurosurgeons a simple to use real time diagnostics tool for identifying a CSF leaksThis technology will significantly reduce the number of undiagnosed and misdiagnosed CSF leaksimproving overall patient outcomes by preventing delayed treatment and the complications that arise from itOur Phase I hypothesis is that a designed nanostructured surface can be functionalized to selectively bind thetransferrin protein unique to CSFinducing a measurable color change in the visible wavelength rangeOur first specific aim is to achieve highly specific nanoreceptors fortransferrin protein binding using synthetic polymersOur second aim is to achieve a color shift aftertransferrin protein bindingby integrating nanoreceptor with structural color reporter elementsIn Phase IIwe plan to develop a largerandquot x andquottest stripcoated with the sensor platformthat can produce a more significant spectra shift upontransferrin protein bindingwhich will be visible by eye under ambient lighting conditionsIt is estimated that there arehospitalizations yearly for TBI and overmillion spinal surgeries per yearIn each casephysicians could benefit greatly by utilizing our technology to confirm or rule out CSF leaksWith potential customers in every hospital in the USwe will first target key neurosurgeons to utilize our sensors in treating TBI and spinal surgeriesfocusing on developing relationships in mid Atlantic US medical marketsIn parallelwe will develop relationships with medical device distribution networks to expand the footprint towards a national market PUBLIC HEALTH RELEVANCE STATEMENT In this SBIRChemeleon Incplans to develop an easy to use colorimetric test strip biosensorthat instantaneously changes colors when cerebrospinal fluidCSFis presentassisting doctors in immediately identify a CSF leak to begin treatmentpreventing future complications and improving patient outcomesThe accurate detection of CSF leakage becomes increasingly crucial in traumatic brain injuriesTBIand during spinal surgerieswhere delayed treatment due to misdiagnosis or undiagnosed leaks leads to significantly increased rates of meningitisbrain infectionsstroke and morbidityCurrent detection technologies require external lab testing and takefive days for results to returnwhere our sensor will be operated by physicians at the point of care and return results almost instantaneously