Rapid Detection of Periprosthetic Joint Infection

快速检测假体周围感染

• 批准号: 8314605
• 负责人: Mitchell C. Sanders
• 金额: $ 29.83万
• 依托单位: ECI BIOTECH
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314605
• 关键词: Antibiotics; Appearance; Arthroplasty; Autoimmune Diseases; Biological Assay; Blinded; Cells; Clinic; Clinical; Collection; Detection; Development; Devices; Diagnosis; Diagnostic; Diffuse; Discrimination; Failure; Feasibility Studies; Future; Hip Joint; Histology; Immune response; Infection; Inflammation; Intervention; Joints; Knee joint; Laboratories; Lateral; Lead; Liquid substance; Microbe; Operative Surgical Procedures; Pain; Patient Care; Patients; Peptides; Performance; Persons; Phase; Predictive Value; Prosthesis; Quality of life; Research; Research Personnel; Rheumatoid Arthritis; Route; Sampling; Screening procedure; Second Look Surgery; Serological; Staphylococcus epidermidis; Symptoms; Synovial Fluid; Technology; Testing; Tissues; Virulence; Virulence Factors; antimicrobial; base; clinical practice; cohort; commensal microbes; commercialization; cross reactivity; effective therapy; high throughput screening; implantation; improved; in vivo; meetings; microbial; novel marker; pathogen; point of care; point-of-care diagnostics; preference; prototype; rapid detection; response marker; treatment planning

DESCRIPTION (provided by applicant): The research proposed in this application aims to develop ECI Biotech's promising technology toward improved diagnosis of periprosthetic joint infection (PJI), and reduction in the unwarranted antimicrobial intervention. Criteria for PJI diagnosis have not been standardized in clinical practice, and symptoms of PJI are sometimes difficult to distinguish from other non-infectious causes of inflammation and pain. Discrimination between infection and other causes of pain/inflammation is crucial to choosing effective treatment and to avoid unnecessary use of antibiotics and/or multistage surgery. An initial feasibility study performed by ECI "clearly identified" two target markers for PJI, when screened against a cohort of clinical synovial fluid samples, gathered from patients with symptoms of PJI. The aim of this application is to transition one or both of these targets from the laboratory-based assay used for initial screening to a prototype point-of- care (PoC) device for future commercialization. In the first aim, the target markers will be integrated into a lateral flow strp PoC diagnostic device. The prototype device will be optimized to mitigate possible cross- reactivity and interference from synovial fluid, especially fluids from persons with autoimmune disorders that involve the synovial fluid especially (rheumatoid arthritis, etc.) In the second aim the prototype device will be tested against a large cohort of patient samples (200+) gathered and banked at the Mayo Clinic, collected from patients undergoing surgical revision for possible PJI. The infection status of these patients will blinded to ECI researchers during assay performance. Diagnosis using ECI's technology is expected to reach 95% accuracy, a significant improvement over current modes of diagnosis currently in use. PUBLIC HEALTH RELEVANCE: Criteria for diagnosis of periprosthetic joint infection (PJI) are not standardized among clinicians, and depend largely on assessment of patient immune response factors, rather than directly assaying for pathogen markers. Misdiagnosis can lead to either inadequate treatment when infections are missed or unnecessary antimicrobial and surgical interventions for infection diagnosis in a joint where no infection actually exists. ECI Biotech's has "clearly identified" two novel markers for detection of infection, which depend on direct markers of pathogenic microbes. Development of ECI Biotech's laboratory assay for PJI in a point-of-care device for commercialization will improve the rate of correct diagnoses, thereby improving patient care and quality of life.

描述（由申请人提供）：本申请中提出的研究旨在开发ECI Biotech有前途的技术，以改善假体周围关节感染（PJI）的诊断，并减少不必要的抗菌干预。PJI诊断标准在临床实践中尚未标准化，PJI的症状有时难以与其他非感染性炎症和疼痛原因区分开来。区分感染和疼痛/炎症的其他原因对于选择有效的治疗和避免不必要的抗生素使用和/或多阶段手术至关重要。由ECI进行的初步可行性研究“明确确定”了PJI的两个靶标记物，当对从PJI症状患者收集的临床滑液样本进行筛选时。本申请的目的是将这些目标中的一个或两个从基于实验室的 用于初始筛选的测定到用于未来商业化的原型床旁（Point-of-Care）装置。 在第一个目标中，目标标记物将被整合到侧流带状疱疹诊断装置中。将对原型器械进行优化，以减轻可能的交叉反应性和滑液干扰，尤其是来自自身免疫性疾病患者的涉及滑液的液体（类风湿性关节炎等）。在第二个目标中，原型器械将根据在马约诊所收集和储存的大量患者样本（200+）进行测试，这些样本是从因可能的PJI而接受手术翻修的患者中收集的。这些患者的感染状态将在检测期间对ECI研究人员设盲。使用ECI技术的诊断预计将达到95%的准确率，这是对目前使用的诊断模式的重大改进。 公共卫生相关性：假体周围关节感染（PJI）的诊断标准在临床医生中尚未标准化，并且在很大程度上取决于对患者免疫应答因子的评估，而不是直接测定病原体标志物。误诊可能导致在感染被遗漏时治疗不充分，或者在实际上不存在感染的关节中进行不必要的抗菌和外科手术诊断。ECI生物技术公司已经“清楚地确定”了两种新的感染检测标记物，它们依赖于病原微生物的直接标记物。ECI Biotech的PJI实验室检测技术的开发将提高正确诊断率，从而改善患者护理和生活质量。