Clinical Study on iNOS EIA for Sepsis and Septic Shock

描述(由申请人提供)：在开发出高度敏感和 我们发现诱导型一氧化氮合酶(INOS)的强健夹心ETA 这种蛋白在全身炎症反应患者的血浆中游离 综合征(SIRS)或败血症，但在从以下来源获得的血浆中检测不到它 健康的个体。我们的新发现使我们提出了 血浆诱导型一氧化氮合酶水平升高可作为一种有效的生化标志物 预测全身炎症反应综合征和/或脓毒症的发病，并监测患者的 状态改善或恶化时的状态。我们的目标是开发一种创新的 新的临床诊断可以快速检测、量化和监测这种情况 严重脓毒症和感染性休克发作前iNOS升高，因此 为未来的有害事件提供早期预警信号。一大早 诊断将为比现在更早开始治疗提供基础 目前正在练习。之前两项研究的结果表明， 慢性阻塞性肺疾病患者血浆诱导型一氧化氮合酶水平升高 SIRS和/或脓毒症，发生在SIRS和/或脓毒症的早期，以及 预测未来的问题。此二期项目的目标是(1)扩展 这项研究对400名患者进行了评估，以评估是否对两名患者进行了观察 较小的患者队列一般适用，以及(2)确定是否 SIRS和脓毒症患者血浆iNOS水平升高是独有的 病理，不会发生在与Over相关的其他疾病中 诱导型一氧化氮合酶的表达。一旦建成，这个项目将带来独一无二的 需要新的临床诊断推向市场，这反过来将导致 改善危重病人的医疗保健。 建议的商业应用： 每年发生超过1,200,000例全身炎症反应综合征和脓毒症 这些疾病每年导致超过500,000例严重败血症和感染性休克，以及每年100,000-250,000例死亡。需要一种快速测试来评估患者进入和沿着脓毒症途径进展到严重的脓毒症和感染性休克。我们的EIA旨在满足这一临床需求，通过减少ICU停留时间来降低患者成本。并改善患者的预后。

DESCRIPTION (provided by applicant): After developing a highly sensitive and robust sandwich ETA for inducible nitric oxide synthase (iNOS), we discovered this protein free in plasma of patients with systemic inflammatory response syndrome (SIRS) or sepsis, but could not detect it in plasma obtained from healthy individuals. Our novel discovery has lead us to proposed that the increased plasma level of iNOS can serve as a valid biochemical marker to prognosticate the onset of SIRS and/or sepsis and to monitor a patient's condition as it improves or deteriorates. Our goal is to develop an innovative new clinical diagnostic that can rapidly detect, quantitate and monitor this increase in iNOS prior to the onset of severe sepsis and septic shock, and thus provide an early warning signal for future deleterious events. An early diagnosis will provide a basis for the earlier initiation of therapies than is currently practiced. The results from two prior studies indicate that an increased plasma level of iNOS can be detected and measured in patients with SIRS and/or sepsis, occurs early in an episode of SIRS and/or sepsis, and forecasts future problems. The aims of this phase 2 project are (1) to extend the study to 400 patients in order to assess if the observations made on two smaller cohorts of patients are generally applicable and (2) to determine if the increased plasma level of iNOS in SIRS and sepsis is unique to this pathology and does not occur in other diseases associated with an over expression of iNOS. Once completed, this project will bring a unique and much needed new clinical diagnostic onto the market, and this, in turn, will lead to improved health care for critically ill patients. PROPOSED COMMERCIAL APPLICATIONS: Over 1,200,000 cases/yr of systemic inflammatory response syndrome and sepsis occur in the USA; these lead to over 500,000 cases/yr of severe sepsis and septic shock and 100,000 - 250,000 deaths/yr. A rapid test to assess a patient's entry into and progress down the sepsis pathway to severe sepsis and septic shock is needed. Our EIA is designed to meet this clinical need, to lower patient cost by reducing the length of ICU stays. and to improve patient outcome.