Diagnostic tool for assessment and tracking of microbial load in bloodstream infections

项目总结 败血症在美国每年导致超过27万人死亡，败血症是对 血流感染(BSI)。BSI的早期诊断和治疗显示患者病情有所改善 结果和减少住院时间。然而，目前公认的诊断方法需要血液 培养步骤，不仅缓慢，而且在抗菌剂存在时敏感性降低 治疗。因此，目前的技术被认为不能可靠地监测一次治疗的有效性 开始了。对于BSI来说，非常需要新的诊断方法，这些方法是无培养的，并提供 在整个护理过程中提供微生物信息。 为了解决这一未得到满足的需求，HelixBind将利用其专有的直接从样本获取的功能(即， 无培养)平台，快速(抗性和病原体鉴定)，以评估微生物负载 对抗菌素干预的反应的感染。RAPID/BSI是该系统的第一个测试，它检测和 在3小时内直接从患者的全血中识别出BSI。整合了广泛的测试菜单和单项 Cfu/ml敏感性，检测不会受到多种微生物感染或抗菌治疗的干扰。横穿 多项临床研究表明，该检测方法具有95%的敏感性和99.8%的特异性。 Rapid/BSI被FDA指定为突破性设备。 作为这一计划的结果，准确评估微生物负载的能力将增加快速/BSI。有了这个 能力到位后，初步测试结果将为临床医生提供病原体识别以及措施 指负荷；感染严重程度的标志。综合起来，这些信息将有助于临床医生进行源头控制和 选择最合适的抗菌干预措施。后续测量将允许临床医生 以测量微生物清除量，这是患者康复的必要条件。除了直接的、特定于患者的影响之外， 该计划将根据需要直接支持改进的抗菌素管理，以应对 抗菌素耐药性病原菌。 我们的具体目标，每个目标都有可量化的交付成果，旨在完成所有技术开发， 与我们的临床合作伙伴合作进行系统验证、压力测试和临床验证。焦点 这项研究的重点将是验证我们创新方法的能力，为进一步的工作奠定基础 旨在优化其在临床环境中的实施。在实现我们的具体目标时，我们将拥有 开发并演示了一种革命性的方法，用于识别、表征、监控和 治疗侵袭性血液感染。

PROJECT SUMMARY Leading to over 270,000 deaths in the US annually, septicemia is the systemic inflammatory response to a bloodstream infection (BSI). Early diagnosis and treatment of BSIs have demonstrated improved patient outcomes and reduced hospitalization time. However, currently accepted diagnostic approaches require a blood culturing step, which is not only slow, but also demonstrates reduced sensitivity in the presence of antimicrobial treatment. Current techniques are therefore considered unreliable for monitoring effectiveness of treatment once begun. There is a significant need for new diagnostic approaches for BSIs that are culture-free and provide microbiological information throughout the course of care. To address this unmet need, HelixBind will leverage the capabilities of its proprietary direct-from-specimen (i.e., culture-free) platform, RaPID (Resistance and Pathogen IDentification) to assess the microbial load of an infection in response to an antimicrobial intervention. RaPID/BSI, the first test for this system, detects and identifies BSIs directly from patient whole-blood within 3 hours. Incorporating a broad test menu with single CFUs/ml sensitivity, the test is not confounded by polymicrobial infections nor antimicrobial treatment. Across multiple clinical studies, the assay has demonstrated >95% sensitivity and >99.8% per assay specificity. RaPID/BSI was designated as a Breakthrough Device by the FDA. As a result of this program, the capability to accurately assess microbial load will be added RaPID/BSI. With this capability in place, initial test results will provide clinicians with pathogen identification along with a measure of load; a marker for infection severity. Combined, this information will assist clinicians in source control and selecting the most appropriate antimicrobial intervention. Follow-up measurements will then allow the clinician to gauge for microbial clearance, a requisite for patient recovery. Beyond the immediate, patient-specific impact, this program will directly support improved antimicrobial stewardship as required to combat the rise of antimicrobial resistance pathogens. Our Specific Aims, each with quantifiable deliverables, are designed to complete all technical development, systems verification, stress testing, and clinical validation in collaboration with our clinical partners. The focus of this study will be to validate the capability of our innovative approach, setting the stage for further work aimed at optimizing its implementation in the clinical setting. In achieving our Specific Aims, we will have developed and demonstrated, a revolutionary approach towards identifying, characterizing, monitoring, and treating invasive infections of the bloodstream.