Clinical Validation of Sinu-Test, A Multiplexed Device for Rapid Diagnosis of Acute Bacterial Sinusitis, to support CLIA Waiver

Sinu-Test（一种用于快速诊断急性细菌性鼻窦炎的多重设备）的临床验证，支持 CLIA 豁免

• 批准号: 10363689
• 负责人: Oriana E. Hawkins
• 金额: $ 86.53万
• 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 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10363689
• 关键词: Accounting; Acute; Adult; Adverse effects; Algorithms; Americas; Antibiotic Resistance; Antibiotics; Bacteria; Biological Assay; Budgets; Caring; Chronic Sinusitis; Clinic; Clinical; Clinical Investigator; Clinical Research; Collection; Communicable Diseases; Complement; Complex; Consult; Development; Devices; Diagnosis; Diagnostic; Diagnostic Reagent Kits; Direct Costs; Drainage procedure; Economic Burden; Endoscopes; Endoscopy; Engineering; Environment; Etiology; Evaluation; Facial Pain; Facilities and Administrative Costs; Fatigue; Fever; Funding; Goals; Guidelines; Health Personnel; Healthcare Systems; Industry; Instruction; Lead; Life; Logistics; Medical Device; Methods; Mucous body substance; Multi-site clinical study; Nasal cavity; Nose; Outpatients; Patient Care; Patients; Performance; Persons; Phase; Physicians; Predisposition; Primary Health Care; Procedures; Process; Reader; Risk; Sampling; Scientist; Sensitivity and Specificity; Sinus; Sinusitis; Site; Societies; Specialist; Specimen; Symptoms; System; Testing; Time; Training; Validation; Veterans; Viral; Visit; accurate diagnosis; acute bacterial sinusitis; acute rhinosinusitis; antibiotic resistant infections; base; cost; cross reactivity; diagnostic tool; experience; improved; multiplex assay; novel; pathogen; patient safety; point of care; point of care testing; point-of-care diagnostics; prototype; rapid diagnosis; rapid test; recruit; 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. The purpose of this renewel is to expand the clinical performance evaluation to include sufficient native specimens to meet the requirements set by FDA for CLIA-Waiver.

项目概要 鼻窦炎是一种常见疾病，每年造成的经济负担超过80亿美元。每年有 1,070 万人 在美国，80% 的人被诊断患有急性鼻窦炎，并接受抗生素处方。然而，较少 超过 10% 的鼻窦炎病例是由细菌引起的；鼻窦炎占成人抗生素处方的比例较高 比任何其他门诊诊断。患有常规上呼吸道疾病（例如鼻窦炎）的患者 前往初级或紧急护理诊所，有接受抗生素的倾向，但没有充分意识到需要 或风险。千分之一的患者因抗生素和药物而遭受严重的、常常危及生命的不良反应 由于抗生素耐药性的威胁迫在眉睫，医生需要更好的工具来诊断鼻窦炎患者。 医疗保健提供者通常缺乏能够揭示疾病根本原因的护理点 (POC) 诊断工具。 病人的病。他们被迫依靠不精确的方法做出诊断决定或转诊患者 在专家的护理下进行复杂的手术。 目前，市场上还没有可用于即时诊断细菌性鼻窦炎的产品： 关心。 ENTvantage Diagnostics 开发了第一个快速护理点诊断测试套件，可以识别 导致细菌性鼻窦炎的三种病原体。该测试套件包含专门的粘液集合 允许对中鼻道（鼻旁窦的引流部位）进行采样的装置，无需 需要内窥镜或专门培训。以我们之前在原型设计和开发过程中取得的成功为基础 为了可行性，我们改进了一种完全多重检测，并结合了简单易用的样品收集装置 在 POC 中使用。在此绩效期间，Entvantage 将评估该药物的临床表现 Sinu-TestTM 细菌检测试剂盒和读数器系统。 Sinu-TestTM 细菌检测试剂盒将得到改进 通过为医生提供准确诊断鼻窦炎患者的方法来改善患者护理 否则将根据经验进行处理。此外，该 POC 测试将提高患者安全性和 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 处方用于治疗鼻窦炎。此次更新的目的是扩大临床表现评估 包括足够的本地标本以满足 FDA 对 CLIA 豁免的要求。