An at-home test for chronic kidney disease

项目摘要 慢性肾脏病（CKD）是一个重大的全球性公共卫生问题。CKD的早期阶段通常不会 出现明显的症状，因此，多达十分之九的受影响成年人不知道自己的病情。 这意味着仅在美国就有大约3000万未确诊的CKD病例。终末期肾病 终末期肾病（ESRD）是未诊断和未治疗的CKD的结果，在糖尿病患者中需要昂贵的肾脏替代治疗。 透析或移植的形式，并导致美国每年1140亿美元的医疗保健支出。 虽然常规筛查有发生CKD风险的患者（例如，高血压患者或 糖尿病），这种策略是昂贵的和不方便的，需要多次诊所访问测试，以准确地 诊断疾病。然而，CKD的正确诊断只需要两个简单的测试： 与肌酐比率（ACR）测试，以寻找尿中的白蛋白，指示肾损伤，和血清 肌酸来估计肾小球滤过率（eGFR）。这两个参数的长期升高可以 用于有效识别CKD患者，并指导他们与医生进行随访治疗。 Scanwell Health是一家数字医疗保健公司，提供简单且负担得起的体外诊断 试验.该公司的目标是为医疗保健公司提供可扩展的诊断， 测试每个人。Scanwell正在开发一种CKD测试，可以实现简单，准确和具有成本效益的 在试剂盒中评估肾功能，该试剂盒可由患者在家中自行给药 环境该测试是一个全面的，用户友好的工具包，旨在与智能手机配合使用 应用程序，允许主动监测肾脏健康。大量的初步数据表明， 使用可重复的尿白蛋白、尿肌酐和血清肌酐的实验室测量， 智能手机应用程序来读取结果。在这里，我们提出了一系列的临床研究，以验证使用的 普通用户手中的Scanwell尿液ACR和血清肌酐检测试剂盒。证明准确 当测试是自我管理时，结果对产品的价值主张至关重要， 测试成本和促进更频繁的监测，而无需诊所访问。 作为第一步，我们将评估外行用户手中的整体可用性，评估套件设计， 说明书、完成测试的难易程度、对产品使用能力的满意度以及患者 对测试结果的信心。我们将遵循这一点与研究基准性能的两个测试 成分（尿ACR和血清肌酐）与现行标准，FDA批准的临床试验， 一名医疗保健专业人员。成功演示准确的结果和出色的易用性将允许 更广泛的CKD筛查，使早期诊断和更有效的监测成为可能。这将 降低CKD对医疗保健系统的成本负担，并改善患者结局。

PROJECT SUMMARY Chronic kidney disease (CKD) is a major global public health problem. The early stages of CKD usually do not present clear symptoms, and, as a result, as many as 9 in 10 affected adults are unaware of their condition. This translates to approximately 30 million undiagnosed CKD cases in the US alone. End-stage renal disease (ESRD) is an outcome of undiagnosed and untreated CKD, requiring costly renal-replacement therapy in the form of dialysis or transplantation and resulting in $114 billion in healthcare spending in the US each year. While routine screening of patients who are at risk for developing CKD (e.g., patients with hypertension or diabetes), this strategy is costly and inconvenient, requiring multiple clinic visits for testing to accurately diagnose the disease. However, proper diagnosis of CKD requires only two simple tests: a urine albumin to creatinine ratio (ACR) test to look for albumin in the urine, indicative of kidney damage, and a serum creatine to estimate the glomerular filtration rate (eGFR). The prolonged elevation of these two parameters can be used to effectively identify patients with CKD and direct them for follow-up with a physician for treatment. Scanwell Health is a digital healthcare company delivering simple and affordable access to in vitro diagnostic testing. The company aims to provide scalable diagnostics for healthcare companies and accurate, at-home testing for everyone. Scanwell is developing a CKD Test that enables simple, accurate, and cost-effective assessment of kidney function in a kit that can be self-administered by the patient in an at-home environment. The test is a comprehensive, user-friendly kit designed to work in conjunction with a smartphone app, allowing proactive monitoring of renal health. Extensive preliminary data demonstrates accurate and repeatable laboratory measurements of urine albumin, urine creatinine, and serum creatinine using a smartphone app to read the results. Here we propose a series of clinical studies to validate the usage of Scanwell’s Urine ACR and Serum Creatinine Test Kits in the hands of lay users. Demonstration of accurate results when the test is self-administered is critical to the value proposition of the product, enabling much lower test costs and facilitating more frequent monitoring without the need for clinic visits. As a first step, we will assess the overall usability in the hands of lay users, assessing kit design, clarity of the instructions, ease of completing the test, satisfaction with the ability to use the product, and patient confidence in the test results. We will follow this with studied benchmarking the performance of the two test components (Urine ACR and Serum Creatinine) to current standard, FDA-cleared clinical tests administered by a healthcare professional. Successful demonstration of accurate results and excellent ease of use will allow for more widespread CKD screening, and enable earlier diagnosis and more efficient monitoring. This will lower the cost burden of CKD on the healthcare system and lead to improved patient outcomes.