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

项目摘要 鼻窦炎是一种常见疾病，每年的经济负担超过80亿美元。每年有1070万人 在美国，被诊断为急性鼻窦炎的人中，80%的人接受抗生素处方。然而， 超过10%的鼻窦炎病例是由细菌引起的;鼻窦炎占更多的成人抗生素处方 比其他门诊诊断都要多患有常规上呼吸道疾病（如鼻窦炎）的患者通常 在没有充分认识到需要的情况下，前往有接受抗生素倾向的初级或紧急护理诊所 或风险。每1000名患者中就有1人因抗生素而遭受严重的、往往危及生命的不良反应， 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。 通常，医疗保健提供者缺乏可以揭示疾病的根本原因的护理点（POC）诊断工具。 病人的病。他们被迫依靠不精确的方法来做出诊断决定或转诊病人 在专家的护理下进行复杂的手术。 目前，市场上还没有产品可用于诊断细菌性鼻窦炎， 在乎ENTvantage Diagnostics开发了第一个快速的即时诊断试剂盒，可以识别 导致细菌性鼻窦炎的三种病原体。包括在这个测试套件是一个专门的粘液收集 允许对中鼻道（鼻旁窦的引流部位）进行采样的器械， 需要内窥镜或专门培训。基于我们之前在原型开发过程中的成功， 可行性，我们已经完善了一个完全多路复用的测定结合一个简单的使用样品收集装置， 在POC中使用。在此性能期间，Entvantage将评价 Sinu-TestTM细菌检测试剂盒和读数系统。Sinu-TestTM细菌检测试剂盒将改善 通过为医生提供准确诊断鼻窦炎患者的方法， 否则将根据经验进行治疗。此外，这种POC测试将提高患者的安全性， 通过减少不必要的抗生素，降低医疗保健系统的直接和间接成本 鼻窦炎的处方。本次更新旨在扩展临床性能评价 包括足够的天然标本，以满足FDA对CLIA豁免的要求。

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.