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

项目摘要 鼻窦炎是一种常见病，每年的经济负担超过80亿美元。每年，有1070万人 在美国，80%的人被诊断为急性鼻窦炎，并收到了抗生素处方。然而，较少 超过10%的鼻窦炎病例是由细菌引起的；鼻窦炎占更多的成人抗生素处方 比其他任何门诊诊断都要好。患有常规上呼吸道疾病的患者，如鼻窦炎，通常 在没有充分认识到需要的情况下，有服用抗生素倾向的去初级或紧急护理诊所就诊 或者风险。每1000名患者中就有1人遭受严重的，通常危及生命的不良反应，原因是抗生素和 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能够揭示潜在原因的护理点(POC)诊断工具 病人的病情。他们被迫依靠不精确的方法来做出诊断决定或转介病人。 在专家的护理下进行复杂的手术。 目前，市场上还没有诊断细菌性鼻窦炎的产品。 关心。ENTvantage诊断公司开发了第一个快速、护理点诊断检测试剂盒，可以识别 导致细菌性鼻窦炎的三种病原体。该检测试剂盒中包括一种特殊的粘液收集 允许对中鼻道，即副鼻窦的引流部位进行取样的装置，而不需要 需要内窥镜检查或专门培训。建立在我们之前在原型制作和开发过程中的成功 可行性，我们已经改进了一种完全多重的检测方法，并结合了一种简单易用的样本采集装置 在概念验证中使用。在此绩效期间，ENTvantage将评估 SINU-TestTM细菌检测试剂盒和阅读器系统。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手段进行患者护理 否则将被经验主义地对待。此外，这项POC测试将提高患者的安全性和 通过减少不必要的抗生素减少医疗系统的直接和间接成本 鼻窦炎的处方药。Renewel的目的是扩大临床绩效评估 包括足够的本地标本，以满足FDA为CLIA豁免设定的要求。

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.