There is an urgent need for rapid diagnostics that are highly sensitive, specific, inexpensive, easy to use, and located in primary care settings to identify bacteria and viruses in cerebrospinal fluid (CSF). The long-term goal of this project is to develop a syndrome-based, multi-target immuno-biosensor for diagnosis of meningitis that can be used as a """"""""first response"""""""" device in hospitals and clinics. The biosensor will target multiple meningitis agents in a single test to identify the etiology in symptomatic patients. The proposed sensor, invented at Michigan State University, uses a conductimetric detection technique to produce qualitative results in 6 to 10 minutes with a lower detection limit of 79 cells/ml for bacteria and 103 viral particles. Rapid BioSense LLC holds an exclusive license for the patent (under review). The overall goal of the project is to transfer this previously demonstrated technology from a University laboratory experiment into a commercially viable product. The overall aim of the Phase I program is to demonstrate the feasibility of the technology as a single pathogen assay for meningitis diagnostics using Neisseria meningitidis in porcine CSF samples and Trans-Isolate medium (a CSF transport medium). ? The Phase I program is focused on three specific aims: ? ? Aim 1: Fabrication of a single-target biosensor for N. meningitidis ? Using methods from preliminary studies, single-target biosensors will be fabricated for detection of N. meningitidis grown in broth media. ? Aim 2: Biosensor testing for N. meningitidis in CSF samples ? Protocols will be developed for testing the biosensor with N. meningitidis in porcine CSF samples (including some blood-tainted CSF samples). Feasibility of the biosensor for human diagnostics will be demonstrated using animal model, and performance of the sensor will be characterized. Combined sample preparation and test time is aimed at less than 30 minutes. ? Aim 3: Biosensor testing for N. meningitidis in Trans-Isolate (T-I) medium ? Feasibility of the biosensor for use with the T-I transport medium will be demonstrated, and performance of the sensor characterized. ? ? The Phase II program will include development of a general meningitis test and a multi-array device for detection of multiple pathogens that cause meningitis, as well as improved sensor design, conductive ink formulation, and application technique for the capture pad electrodes. Following Phase II, clinical trials will be conducted, and FDA approvals for the diagnostic device will then be sought. ? ? The proposed biosensor is inexpensive and well-suited to the task of rapidly detecting pathogens causing bacterial meningitis. This will help healthcare providers quickly identify the potential cause of meningitis (bacterial or viral), collaborate with epidemiologists to determine the source of an epidemic and minimize its effects, achieve faster prognosis in patients, and aid targeted treatment of the disease. This is important in preventing increase in resistance of pathogens to antibiotics resulting from indiscriminate use of antibiotics, as well as reducing health costs and man-hours lost associated with misdiagnosed illnesses, unnecessary hospitalizations and tests performed. Commercialization of the conductimetric sensor technology will enable improvement in the overall quality of human life, not only in the US but around the world. ? ? ?
