A Rapid Multiplexed Test for the Screening of Sepsis and Organ Dysfunction at the Point of Care

用于在护理点筛查脓毒症和器官功能障碍的快速多重检测

• 批准号: 9909157
• 负责人: Johann Desa
• 金额: $ 22.5万
• 依托单位: INSTADIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-15 至 2021-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9909157
• 关键词: Accident and Emergency department; Antigens; Area; Bedside Testings; Bilirubin; Biological Assay; Biological Markers; Blood; Blood Plasma Volume; Blood Pressure; Blood Tests; Blood Urea Nitrogen; Bread; Buffers; C-reactive protein; Care Technology Points; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Clinical Research; Creatinine; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Disease Management; Early Diagnosis; Evaluation; Fibrin fragment D; Fibrinogen; Functional disorder; Goals; Grant; Health; Health Personnel; Health care facility; Heart Rate; Hospitals; Hour; Human; Immune response; Immunoassay; Individual; Infection; Inflammation; Laboratories; Life; Measurement; Measures; Medical; Medical Care Costs; Monitor; Neighborhoods; Organ; Organ failure; Outcome; Patient Care; Patient Monitoring; Patients; Performance; Phase; Plasma; Play; Preventive care; Primary Health Care; Process; Reader; Running; Sampling; Sepsis; Septic Shock; System; Technology; Temperature; Test Result; Testing; Time; Training; Treatment outcome; Visit; Wait Time; Whole Blood; biochip; community clinic; design; disability; empowered; follow-up; high risk; improved; improved outcome; mortality risk; outcome forecast; patient population; point of care; point-of-care diagnostics; portability; primary care setting; procalcitonin; prototype; response; satisfaction; screening; sensor; stem; tool; urgent care

Abstract Instadiagnostics (IDI) is developing a point-of-care (POC) diagnostic technology platform with the goal of providing early detection, screening, and treatment monitoring for patients at primary care centers, community clinics, urgent care centers, and emergency departments. The device consists of a portable reader (the InstaReader) and disposable cartridges (InstaCartridge). A range of disease specific cartridges will allow for multiple diseases be detected on a single device. The system's ability to provide clinical laboratory quality results in less than 15 minutes will give medical workers the capability to immediately diagnose patients, and allows patients to avoid additional trips to have blood drawn, lengthy wait times for results, or delays in diagnosis and follow up testing. IDI's diagnostic platform will improve patient care/satisfaction, medical outcomes, and workflow for healthcare providers, while reducing overall medical costs. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. Organ dysfunction is closely associated with sepsis and it is rare that just a single organ is impacted, the higher number of organs impacted the higher is the risk for mortality. Globally sepsis is the most preventable cause of death and disability, with over 30 million cases diagnosed annually and 6 million deaths. In the U.S. the CDC estimates that there are approximately 1.7 million cases and 270,000 deaths annually. There is strong evidence that if diagnosed early, sepsis is largely preventable and organ dysfunction is reversible. Blood tests for infection, inflammation, and organ dysfunction can aid in the screening and early diagnosis of sepsis, especially in primary care facilities. However, most of these tests are performed in centralized laboratories and it can take hours or even days to get the results allowing for the progression to severe sepsis and organ failure. Therefore, an improved, multiplexed test, for screening high-risk individuals for sepsis and organ dysfunction performed immediately at the POC, is essential to improve prognosis for these individuals. Our overall Sepsis goal is to develop a multiplexed test for Procalcitonin (PCT), C-Reactive Protein (CRP), Lactate, Creatinine, Bilirubin, Blood Urea Nitrogen, Fibrinogen, and D-Dime. This Phase I will be focused on: Aim 1: Develop and characterize assays for PCT, CRP, Lactate and Creatinine Aim 2: Development of a multi-technology bread-board reader and multiplexed cartridge to simultaneously measure levels of PCT, CRP, Lactate, and Creatinine in the same sample Phase II will focus on expanding on the panel, and conducting a pilot clinical study to demonstrate the performance and utility of the test. It will then be followed with organ specific panels for further patient evaluation.

摘要 Instadiagnostics（IDI）正在开发一种床旁（POC）诊断技术平台，其目标是 为初级保健中心、社区和社区的患者提供早期发现、筛查和治疗监测 诊所，紧急护理中心和急诊室。该设备包括一个便携式阅读器（ InstaReader）和一次性检测盒（InstaCartridge）。一系列疾病特异性药筒将允许 在一台设备上检测多种疾病。系统提供临床实验室质量的能力 在不到15分钟的时间内得出结果，将使医务工作者能够立即诊断病人， 允许患者避免额外的旅行抽血，等待结果的漫长时间，或延迟， 诊断和后续测试。IDI的诊断平台将改善患者护理/满意度，医疗 结果和工作流程，同时降低整体医疗成本。 脓毒症被定义为由宿主对感染的反应失调引起的危及生命的器官功能障碍。 器官功能障碍与脓毒症密切相关，很少只有一个器官受到影响， 受影响的器官数量越多，死亡风险越高。在全球范围内，脓毒症是最可预防的 死亡和残疾的原因，每年有超过3000万例确诊病例和600万例死亡。在美国 CDC估计每年大约有170万例病例和27万例死亡。有 有力的证据表明，如果早期诊断，脓毒症在很大程度上是可以预防的，器官功能障碍是可逆的。血液 对感染、炎症和器官功能障碍的检测有助于败血症的筛查和早期诊断， 尤其是在初级保健机构。然而，大多数这些测试是在集中实验室进行， 可能需要几个小时甚至几天才能得到结果，从而导致严重的脓毒症和器官衰竭。 因此，一种改进的多重测试，用于筛查脓毒症和器官功能障碍的高危个体， 在POC中立即进行，对于改善这些个体的预后至关重要。 我们的总体败血症目标是开发一种多重测试降钙素原（PCT），C反应蛋白（CRP）， 乳酸盐、肌酐、胆红素、血尿素氮、纤维蛋白原和D-二聚体。第一阶段将侧重于： 目的1：开发和表征PCT、CRP、乳酸盐和肌酐的测定方法 目标2：开发多技术试验板读取器和多路复用盒， 测量同一样本中PCT、CRP、乳酸盐和肌酐的水平 第二阶段将集中在扩大小组，并进行试点临床研究，以证明 测试的性能和实用性。随后将进行器官特异性检查，以进一步检查患者 评价