Soluble Decoy Receptor 3 in Bacterial Infection and Sepsis

DESCRIPTION (provided by applicant): Sepsis is a serious inflammatory reaction of the body due to bacterial infection, and the mortality rate of severe sepsis is high in intensive care units around the world. There is a great need for inventing a reliable marker to diagnose patients with sepsis in its early stage so that appropriate therapeutic intervention can be made without delay. We found that a novel soluble decoy receptor DcR3 in the tumor necrosis factor receptor family is selectively increased in human cells in response to bacterial antigens, and that the level of DcR3 in sera of patients with suspected bacterial infections is significantly higher than those of patients with virus associated diseases. Therefore, we hypothesize that DcR3 expression might be increased in patients with sepsis and that the serum level of DcR3 will be useful to predict sepsis with high sensitivity and specificity. To investigate this, we propose to accomplish two goals in this phase-I SBIR study. First, we propose to develop a well characterized rapid immunological assay and validate it in accordance with the regulatory guidelines so that the assay can be adapted in future clinical settings. Second, by using this assay, we propose to assess the level of DcR3 in clinical sera of sepsis patients in comparison with sera of patients with systemic inflammatory response syndrome, a condition similar to sepsis but non-bacterial etiology. Undoubtedly, the successful completion of phase-I feasibility study will lay the groundwork for our future phase-II SBIR study and also demonstrate the potential for future commercialization of ELISA as a diagnostic test to predict sepsis. If the serum level of DcR3 can be effective in the assessment of patients with sepsis, this will aid physicians in deciding the proper course of therapeutic intervention thus increasing the success rate of therapy and reducing the burden of medical care costs, as well as enhancing the quality of the patient's life.