Sinu-Test, A Multiplexed Device for Rapid Diagnosis of Acute Bacterial Sinusitis

Sinu-Test，一种用于快速诊断急性细菌性鼻窦炎的多重设备

• 批准号: 9910481
• 负责人: Oriana E. Hawkins
• 金额: $ 76.27万
• 依托单位: ENTVANTAGE DX
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2021-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9910481
• 关键词: Accounting; Acute; Adult; Adverse effects; Algorithms; Americas; Antibiotic Resistance; Antibiotics; Bacteria; Bedside Testings; Biological Assay; Caring; Chronic Sinusitis; Clinic; Clinical; Clinical Investigator; Clinical Research; Collection; Communicable Diseases; Complement; Complex; Consult; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Direct Costs; Drainage procedure; Economic Burden; Endoscopes; Endoscopy; Engineering; Etiology; Evaluation; Facial Pain; Facilities and Administrative Costs; Fatigue; Fever; Foundations; Funding; Goals; Guidelines; Health Personnel; Healthcare Systems; Industry; Instruction; Investments; Lead; Life; Logistics; Medical Device; Methods; Mucous body substance; Multi-site clinical study; Nasal cavity; National Institute of Allergy and Infectious Disease; Nose; Outpatients; Patient Care; Patients; Performance; Phase; Physicians; Positioning Attribute; Predisposition; Primary Health Care; Procedures; Process; Reader; Reproducibility; Resources; Risk; Sampling; Scientist; Sensitivity and Specificity; Sinus; Sinusitis; Site; Societies; Specialist; Specimen; Symptoms; System; Testing; Time; Training; Veterans; Viral; Visit; accurate diagnosis; acute bacterial sinusitis; acute rhinosinusitis; antibiotic resistant infections; base; cost; experience; improved; manufacturing scale-up; novel; pathogen; patient safety; performance tests; point of care; point-of-care diagnostics; prototype; rapid diagnosis; respiratory; sample collection; side effect; success; tool; urgent care; waiver

Project Summary Sinusitis is a common illness with an annual economic burden of over $8 billion. Each year, 10.7 million people are diagnosed with acute sinusitis in the U.S. and 80% receive a prescription for antibiotics. However, less than 10% of sinusitis cases are caused by bacteria; sinusitis accounts for more adult antibiotic prescriptions than any other outpatient diagnosis. Patients with routine upper respiratory illnesses, such as sinusitis, often visit primary or urgent care clinics with a predisposition to receive antibiotics without fully appreciating the need or risks. With 1 in 1000 patients suffering serious, often life-threatening, adverse effects due to antibiotics and the looming threat of antibiotic resistance, physicians need better tools to diagnose patients with sinusitis. Often healthcare providers lack point-of-care (POC) diagnostic tools that can reveal the underlying cause of a patient’s illness. They are forced to rely on imprecise methods to make diagnostic decisions or refer patients for complex procedures under a specialist’s care. Currently, there are no products available on the market to diagnose bacterial sinusitis at the point-of- care. ENTvantage Diagnostics has developed the first rapid, point-of-care diagnostic test kit that can identify the three pathogens responsible for bacterial sinusitis. Included in this test kit is a specialized mucus collection device that allows for sampling of the middle meatus, the drainage site of the paranasal sinuses, without the need for an endoscope or specialized training. Building on our prior successes during prototyping and feasibility, we have refined a fully multiplexed assay combined with a simple to use sample collection device to be used at the POC. During this performance period, Entvantage will evaluate the clinical performance of the Sinu-TestTM Bacterial Assay Kit and reader system. The Sinu-TestTM Bacterial Assay Kit will improve patient care by providing physicians with a means to accurately diagnose patients with sinusitis who otherwise would be treated empirically. In addition, this POC test will improve patient safety and reduce direct and indirect costs to the healthcare system by reducing unnecessary antibiotics prescribed for sinusitis.

项目摘要 鼻窦炎是一种常见的疾病，年度经济烧伤超过80亿美元。每年，有1070万人 在美国被诊断出患有急性鼻窦炎，80％的人接受抗生素处方。但是，少 超过10％的鼻窦炎病例是由细菌引起的。鼻窦炎占成年抗生素处方的更多 比任何其他门诊诊断。常规上呼吸道疾病的患者，例如鼻窦炎，通常 访问初级或紧急护理诊所，倾向于接受抗生素，而无需完全欣赏需要 或风险。 1000名患者中有1名因抗生素和 抗生素耐药性的损失威胁，医生需要更好的工具来诊断鼻窦炎患者。 通常，医疗保健提供者缺乏护理点（POC）诊断工具，可以揭示出的根本原因 病人的病。他们被迫依靠坚不可摧的方法来做出诊断决定或推荐患者 在专家的护理下进行复杂的程序。 目前，市场上尚无产品诊断细菌鼻窦炎 关心。 Intvantage Diagnostics开发了第一个快速的，即时的诊断测试套件，可以识别 导致细菌鼻窦炎的三种病原体。此测试套件中包括一个专门的粘液收集 允许在中间肉类采样的设备，即副窦的排水位点，没有 需要内窥镜或专门培训。基于我们在原型制作过程中取得的先前成功和 可行性，我们已经完善了一个完全多路复用的组装，并结合了一个易于使用的示例收集设备 在POC中使用。在此表现期间，诱惑将评估 SINU-TESTTM细菌测定套件和读取器系统。 SINU-TESTM细菌测定套件将改善 通过为医生提供准确诊断鼻窦炎患者的手段，患者护理 否则将受到经验对待。此外，该POC测试将改善患者的安全性和 通过减少不必要的抗生素来降低医疗保健系统的直接和间接成本 开处方用于鼻窦炎。