Sensitive Detection of Bacterial Contamination in Platelets

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DESCRIPTION (provided by applicant): Bacterial contamination of platelets is the leading cause of morbidity and mortality from a transfusion- transmitted infection. Bacterial contamination rates for platelets have been estimated to occur at a frequency of 1 in 2,000 to 1 in 3,000 platelet units. Projected fatalities from these transfusions, based on extrapolation from surveillance and other studies, vary from 15 to over 200 per year. There are several technical approaches for bacterial detection in platelets but none have been widely accepted because they either lack the speed or sensitivity required. Lynntech proposes an innovative, easy-to-operate, quantitative, real-time convective PCR (QC-PCR) thermal cycling bacteria detection system (BDS) to achieve the speed and sensitivity required for platelets testing near the time of release. The QC-PCR based BDS provides random-access nucleic acid testing in one hour, from nucleic acid extraction to amplification and real-time detection. The technology is anticipated to be able to detect a broad range of bacteria in platelets at a detection limit between 102 to 103 CFU per/mL (1 to 10 genomic copies per PCR reaction). Because platelets, especially the pooled random donor whole-blood derived platelets, are processed immediately before release, rapid bacterial detection is needed to test the discrete samples. The system's random-access nucleic acid analysis capability, therefore, meets the critical needs of transfusion services which do not process high numbers of platelets for transfusion simultaneously. Users will not need to wait for completion of other PCR reactions before running more samples. This innovative system will help reduce the delay in processing and release of platelet units that are currently associated with culture based methods. In addition, each test requires only 200 ¿L of platelets. This will significantly reduce the loss of platelets to culture-based methods which each require 3 to 5 mL of platelets. In short, the implementation of the system will significantly reduce the number of cases of infections and fatalities, improving the patients' quality of life and saving the health care system millions of dollars annually. Also, important is the simplicity of the system which leads to low-cost systems for hospitals and blood banks to purchase. Lynntech's QC-PCR based BDS is the next generation of tool for molecular diagnostics that will enable a non-specialized operator to perform sophisticated biological tests in any setting with greater speed at a lower cost. The QC-PCR technology can be adapted to run virtually any existing and future PCR based clinical diagnostic assays. By significantly simplifying and accelerating testing, the BDS system could allow for molecular diagnostic testing at doctors' offices as well as hospitals in point-of-care format. The system will also be great for resource poor countries. This technology provides an opportunity for better management of the quality of platelet supply affecting millions of Americans annually, specifically for preventing bacterial related infections and sepsis through transfusion of contaminated platelets. The economic impact is also enormous considering the market size and associated savings from prolonging platelet shelf life and improving infection prevention. Once developed, the product can also be expanded for use to detect pathogens in other blood product components. Also, the system will have great commercial potential and medical values in providing rapid, low-cost, easy-to-use in- vitro diagnostics in doctors' offices, clinics, hospitals, and even in countries with poor resources.