Electrical System for Rapidly Detecting Viable Bacteria in Blood Culture

DESCRIPTION provided by applicant Background Each year in the US there are over Million Blood Cultures performed to determine the presence absence of viable microorganisms in the blood of patients suspected of having Blood Steam Infection BSI or Septicemia Current technology for Blood Cultures typically takes days to provide a result Our proposed system would enable the user to obtain Blood Culture results in hrs instead which will greatly improve the outcomes for patients with Sepsis Innovation At the core of the system lies a patent pending electrical method which can detect proliferating microorganisms in suspensions based on charges stored at the intact cell membranes of live microorganisms This approach was shown prior to Phase I to be X faster than the current methods employed in BACTEC TM current Gold Std However in order to achieve the desired sensitivity our method required that aliquots be periodically withdrawn from the broth blood culture medium patient blood into a thin long chamber for an andquot electrical scanandquot impedance measurements are frequencies KHz MHz The data from this andquot scanandquot is then analyzed to calculate the andquot Bulk Capacitanceandquot Cb a parameter that rises with the rise in the number of live microbes We successfully achieved our Phase I goals by showing that a the automated sampling could be repeatedly performed aseptically over days x longer than foreseen need b the sophisticated electrical measurements needed could be obtained using a circuit designed and assembled by us and c the threshold concentrations and hence Times to Detection TTDs using our Phase I were much lower than those of BACTEC TM Approach In Phase II we propose to a build an unit andquot researchandquot unit b verify the robustness of our device its abilit to handle different volumes of blood with different properties such as hematocrit and WBC counts c verify our ability to correctly diagnose clinical samples using the unit system and d design using andquot Good Design Principlesandquot andamp keeping records in a andquot Device History Fileandquot a unit andapos market readyandapos system By the end of the funded period yrs we will be ready to meet with the FDA armed with a Device History File documenting the development of the product unit system andamp clinical studies NB not clinical trials showing equivalency to existing devices such as BACTECTM in terms of being able to correctly identify positives and also demonstrate improved performance reduced TTDs to potential partners and or investors PUBLIC HEALTH RELEVANCE Each year in the US there occur over cases of Sepsis the systemic inflammation in response to infection by bacteria and or other microorganisms of normally sterile tissues like blood out of which require intensive care and are fatal The high mortality rate is a direct function of the time needed to detect the presence of bacteria in blood The proposed instrument will cut down the time needed for blood cultures from days to andlt hours thereby ensuring much improved patient outcomes