I-Corps Program for A rapid instrument-free diagnostic assay for the early detection and quantification of sepsis biomarkers in blood.

I-Corps 计划用于快速无仪器诊断测定，用于血液中脓毒症生物标志物的早期检测和定量。

• 批准号: 9411541
• 负责人: Alberto Gandini
• 金额: $ 4.9万
• 依托单位: ACCEL DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-23 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9411541
• 关键词: Accident and Emergency department; Address; Affect; Ambulances; American; Antibiotic Therapy; Antibiotics; Antibodies; Award; Bedside Testings; Biological Assay; Biological Markers; Biomedical Engineering; Blood; Blood specimen; Businesses; Calibration; Cardiovascular system; Caring; Cause of Death; Chemistry; Clinic; Clinical Research; Clinical Trials; Complex; Deposition; Detection; Development; Devices; Diagnosis; Diagnostic; Early Diagnosis; Elements; Equipment; Fingers; Functional disorder; Future; General Population; Gold; Health; Hospitalization; Hospitals; Hour; Hypotension; Immobilization; Immunoassay; Impairment; In Vitro; Incidence; Innovation Corps; Intuition; Laboratories; Legal patent; Magnetism; Measurement; Measures; Medical Technology; Microspheres; Monitor; Multi-Institutional Clinical Trial; National Heart, Lung, and Blood Institute; Organ; Pain; Patient Care; Patient risk; Patients; Phase; Physical Function; Physicians; Preparation; Procedures; Process; Public Health; Reader; Reagent; Recording of previous events; Refrigeration; Research; Sample Size; Sampling; Sepsis; Small Business Innovation Research Grant; Statistical Data Interpretation; Supervision; Surface; Systemic infection; Technology; Testing; Time; Tissues; Titrations; Training; Translating; Universities; Validation; Whole Blood; antimicrobial; base; blood-based biomarker; clinical Diagnosis; clinically relevant; commercialization; cost; design; diagnostic assay; early onset; emergency service responder; experience; experimental study; handheld equipment; hypoperfusion; improved; instrument; killings; mortality; multidisciplinary; novel; point of care; point-of-care diagnostics; pre-clinical; procalcitonin; programs; prototype; public health relevance; scale up; screening; specific biomarkers; standard of care; success; tool; validation studies

 DESCRIPTION (provided by applicant): The objective of this proposed SBIR Phase I is to complete the proof-of-principle of a novel blood based biomarker assay for the diagnosis and management of Sepsis, pScreen-Sep(tm). pScreen- Sep(tm) has several unique features. It is fully disposable (single use) and does not requires external electronic equipment (i.e., benchtop or handheld devices), hence it is easy to use and very affordable; it is also a quantitative and sensitive platform, hence it provides an accurate and precise quantification of the level of key sepsis biomarkers, such as procalcitonin (PCT). Current research has shown PCT to be a promising biomarker for indicating early onset of sepsis in at risk patients. Severe sepsis, systemic infection and organ dysfunction or tissue hypoperfusion, affects over a million Americans every year, and the incidence of sepsis is increasing at a drastic rate. Severe sepsis kills 20-50% of patients and is the 10th leading cause of death overall in the US, while patients who survive often experience pain, impaired physical functionality, and overall worse health than the general population during their lifetime. Sepsis and related hospitalization cost over $20 billion annually in the US alone, making it the most expensive condition treated in US hospitals. One of the major challenges associated with effective sepsis treatment is the difficulty in early recognition and diagnosis. Starting antibiotics within one hour following the observation of hypotension was found to significantly decrease mortality from sepsis, yet over 50% of patients do not receive antibiotics from more than six hours following onset of hypotension. One study showed that survival decreased by 7.6% per hour that antimicrobial therapy was delayed in the first six hours following the onset of hypotension. A clear and critical need for a prognostc tool exists for diagnosis and management of sepsis. Our solution enables physicians and first responders to rapidly monitor and diagnose potential sepsis at the Point-of-Care of patients. pScreen-sep(tm) is based on a patent-protected technology developed at Carnegie Mellon University, which has been extensively verified in our laboratory. In this Phase I proposal, we will optimize key elements of our latest prototype and complete a detailed validation study that includes positive and negative controls. A clinical trial to support the FDA premarket approval would then follow in a Phase II effort.

 描述（由适用提供）：该拟议的SBIR I期的目的是完成一种新型血液生物标志物测定的原则证明，以诊断和管理败血症，Pscreen-Sep（TM）。 Pscreen-Sep（TM）具有几个独特的功能。它是完全一次性的（一次性），不需要外部电子设备（即台式或手持设备），因此易于使用且价格合理；它也是一个定量和敏感的平台，因此，它提供了对关键败血症生物标志物（例如procalcitonin（PCT））的准确而精确的量化。当前的研究表明，PCT是表明AT风险患者早期发作的有前途的生物标志物。严重的败血症，全身感染和器官功能障碍或组织灌注不足，每年都会影响超过一百万的美国人，并且败血症的事件正在增加。严重的败血症杀死了20-50％的患者，是美国总体死亡的第十大死亡原因，而生存的患者通常会遭受疼痛，身体功能受损和总体健康状况比一生中的一般人群差。仅在美国，败血症及相关住院每年耗资超过200亿美元，使其成为美国医院治疗的最昂贵的病情。与有效败血症治疗相关的主要挑战之一是困难 在早期识别和诊断中。在观察到低血压后的一小时内开始抗生素可显着降低败血症的死亡率，但是超过50％的患者在低血压发作后未从六个小时以上接受抗生素。一项研究表明，在低血压发作后的前六个小时内，抗菌治疗延迟了每小时的生存率下降7.6％。对于脓毒症的诊断和管理，存在对Prognostc工具的明显而迫切的需求。我们的解决方案使医生和急救人员能够在患者的护理点快速监测和诊断潜在的败血症。 Pscreen-Sep（TM）基于卡内基·梅隆大学（Carnegie Mellon University）开发的专利保护技术，该技术已在我们的实验室进行了广泛验证。在此阶段I建议中，我们将优化最新原型的关键要素，并完成包括正面和负面对照的详细验证研究。一项支持FDA前市场批准的临床试验将在II期努力下进行。