Detection of Biofilm Bacteria using GloBac

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DESCRIPTION (provided by applicant): The microbiologic diagnosis of infected joint anthroplasty is inaccurate using current techniques. Dr. Robin Patel has developed and validated a new technique that samples microorganisms in biofilms on the surface of explanted orthopedic implants. This technique yields biofilm microorganisms suspended in solution; currently these organisms are detected using plate culture. This approach is {more} sensitive, yet as specific as periprosthetic tissue culture. However, it is not rapid and therefore not amenable to intraoperative use. An intraoperative prosthetic joint infection diagnostic would enable appropriate surgical decisions to be made in the operating room, and could potentially be faster and more objective than the currently used frozen section evaluation. Using the new technique, biofilm microorganisms are suspended in solution in high quantity (i.e., >200 cfu/ml); they should therefore be amenable to direct detection. A rapid, automated, sensitive, cost-effective method for detection of suspended biofilm bacteria would enable a rapid prosthetic joint infection diagnostic amenable to intraoperative application. Dr. Patel s group has demonstrated that Gram stain of the suspended biofilm bacteria is 48% sensitive, which is improved compared to periprosthetic tissue Gram stain (sensitivity 19%), but still inadequate for an intraoperative diagnostic. Improved sensitivity is needed. SUBC, Inc. is developing a novel, sensitive, fully automated, microprocessor driven viable bacterial detection system called "GloBac". This novel technology is being designed to provide a {90 second} sensitive and specific bacterial detection test based on the measurement of bacterial ATP, and is anticipated to be cost-effective. The goal of this phase I STTR proposal is to develop the GloBac rapid bacterial detection system and to determine if this novel system can rapidly, sensitively and specifically detect planktonic and biofilm bacteria isolated from patients with prosthetic joint infection. Assuming feasibility in phase I, phase II will consist of refinement of the GloBac system for use in surgical suites and clinical validation by prospectively testing patients undergoing knee or hip arthroplasty revision or resection {i.e., without the need for culture}. This system is potentially applicable to testing of other clinical specimens including, but not limited to, dislodged biofilm bacteria from other foreign bodies, and synovial fluid. PUBLIC HEALTH RELEVANCE: Hip and knee replacements are being performed with increasing frequency; while most patients who undergo this type of surgery experience relief of pain and restoration of joint function, some require repeat surgery for infection or other reasons. Surgical and medical management of failed joint replacements depend on whether or not infection is present; there is currently no way to rapidly detect bacteria causing infection in the operating room in patients undergoing surgery for a failed joint replacement. The goal of the proposed studies is to develop a rapid test for detection of bacteria on artificial joints that can be used in the operating room to diagnose infected artificial joints.