Diagnostic Tool for the Point-of-Care Detection of Infection in Chronic Wounds

描述（由申请人提供）：感染是500万至600万美国慢性伤口的主要问题，因为它干扰正常愈合过程并增加严重并发症的风险，这些并发症通常需要截肢或导致死亡。成功治疗慢性伤口的一个重要障碍是无法正确诊断感染。大多数临床医生仍然依赖于指示急性或手术伤口感染的视觉体征和症状，但已被证明对于慢性伤口感染的诊断是不准确的。该提案的主要目的是优化和验证一种新型诊断测试，使医生或护士能够更好地在护理点检测慢性伤口感染。我们的总体目标是为医院、伤口护理诊所、门诊中心和长期护理机构生产一种简单的一次性诊断设备。当伤口内的细菌浓度超过表明感染的水平时，器械将在15分钟内给出可见的是或否结果。这将有助于公共卫生，帮助慢性伤口的个人更快地接受适当的治疗，这将加速愈合过程，减轻他们的痛苦和不适，并降低感染并发症的风险。我们的第一阶段目标集中在开发一种功能性诊断测定法，该测定法被证明可以检测慢性伤口中的细菌，相对于标准微生物学技术具有优异的诊断灵敏度和特异性。我们第二阶段的具体目标是集中在诊断测试的改进和验证。第一个目的是评估一种更准确和可靠的方法收集组织液从慢性伤口。这将有助于减少收集的样本体积的变化，这将提高测试的诊断准确性。我们的第二个目标是将定量ELISA格式的测定读数改变为基于二进制侧流的测试。该过程中的一个重要步骤是使用经验证的标准品为侧流水线开发设定适当的阈值。最后，我们计划使用来自三种主要慢性伤口类型（糖尿病性溃疡、压力性溃疡和静脉性溃疡）患者的样本评价测试的诊断性能。将诊断试验的结果与诊断慢性伤口感染的参考标准进行比较，以计算灵敏度和特异性。本临床研究的数据将评价诊断试验检测慢性伤口感染的能力，并将证明器械的临床实用性。公共卫生相关性：该项目的目标是开发一种简单，廉价的即时诊断测试，以帮助临床医生快速确定慢性伤口是否感染。早期和更准确的感染诊断将使患者能够更快地接受适当的治疗，从而减少疼痛和痛苦，降低严重感染相关并发症的风险。

DESCRIPTION (provided by applicant): Infection is a major problem for the 5 to 6 million Americans with chronic wounds because it interferes with the normal healing process and increases the risk of serious complications that often necessitate limb amputation or result in death. A significant obstacle to the successful treatment of chronic wounds is the inability to correctly diagnose infection. Most clinicians still rely on visual signs and symptoms that are indicative of infection in acute or surgical wounds but have been proven to be inaccurate for diagnosis of infection in chronic wounds. The primary objective of this proposal is to optimize and validate a novel diagnostic test that will better enable physicians or nurses to detect chronic wound infection at the point-of- care. Our overall objective is produce a simple, single-use diagnostic device for hospitals, wound care clinics, outpatient centers, and long-term care facilities. The device will give a visible, yes-or-no result within 15 minutes when the bacterial concentration within the wound exceeds a level demonstrated to be indicative of infection. This would benefit public health by assisting individuals with chronic wounds to receive the appropriate treatment sooner, which will accelerate the healing process, relieve their suffering and discomfort, and lower the risk of infectious complications. Our Phase I objectives focused on the development of a functional diagnostic assay that was demonstrated to detect bacteria in chronic wounds with excellent diagnostic sensitivity and specificity relative to standard microbiological techniques. Our Phase II specific aims are focused on improvement and validation of the diagnostic test. The first aim is to evaluate a more accurate and reliable method of collecting tissue fluid from chronic wounds. This will help to reduce variability in the sample volume collected, which will improve diagnostic accuracy of the test. Our second objective is to change the assay readout from a quantitative ELISA format into a binary lateral flow-based test. An important step in this process is setting the appropriate threshold for the lateral flow line development using validated standards. Lastly, we plan to evaluate the diagnostic performance of test with samples from patients within the three major chronic wounds types: diabetic, pressure, and venous ulcers. Results of the diagnostic test will be compared to a reference standard for diagnosis of chronic wound infection to calculate the sensitivity and specificity. The data from this clinical study will evaluate the ability of the diagnostic test to detect chronic wound infection and will demonstrate clinical utility of the device. PUBLIC HEALTH RELEVANCE: The project goal is to develop a simple, inexpensive point-of-care diagnostic test to help clinicians rapidly determine if a chronic wound is infected. Earlier and more accurate infection diagnosis will allow patients to receive the appropriate treatment sooner, resulting in less pain and suffering and a lower risk of serious infection-related complications.