Diagnostics via Rapid Enrichment, Identification, and Phenotypic Antibiotic Susceptibility Testing of Pathogens from Blood.

通过血液中病原体的快速富集、鉴定和表型抗生素敏感性测试进行诊断。

• 批准号: 9918850
• 负责人: Kyle Andrew Tipton
• 金额: $ 110.95万
• 依托单位: TALIS BIOMEDICAL CORPORATION
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-11 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9918850
• 关键词: Address; American; Antibiotic Resistance; Antibiotic Therapy; Antibiotic susceptibility; Antibiotic-resistant organism; Antibiotics; Antimicrobial Resistance; Antimicrobial susceptibility; Area; Bacterial Antibiotic Resistance; Biological Assay; Blood; Blood specimen; California; Candida albicans; Centers for Disease Control and Prevention (U.S.); Chemistry; Chicago; Clinical; Communicable Diseases; Consumption; Detection; Development; Diagnosis; Diagnostic; Drug resistance; Economic Burden; Engineering; Enterobacteriaceae; FDA approved; Genomics; Gram-Negative Bacteria; Gram-Positive Bacteria; Growth; Health Personnel; Hour; Human; Industrialization; Infection; Institutes; Institution; Intellectual Property; Investments; Joints; Label; Letters; Life; Measures; Medical; Medicine; Metabolic; Methodology; Methods; Molecular Biology; Mutation; Nucleic Acids; Pathogen detection; Pharmaceutical Preparations; Phenotype; Predisposition; Preparation; Procedures; Protocols documentation; Publications; Reagent; Reporting; Research; Resistance; Resistance profile; Resort; Sampling; Savings; Sensitivity and Specificity; Sepsis; Structure; Technology; Testing; Time; Universities; antimicrobial; bacterial resistance; base; bioinformatics pipeline; clinical development; cost; design; digital; drug development; experience; fungus; global health; human pathogen; innovation; innovative technologies; microbial; multidisciplinary; multiplex detection; new technology; pathogen; pathogenic bacteria; pathogenic microbe; point of care; point-of-care diagnostics; product development; rapid technique; resistant strain; response; single molecule

PROJECT SUMMARY This project “Diagnostics via Rapid Enrichment, Identification, and Phenotypic Antibiotic Susceptibility Testing of Pathogens from Blood,” submitted under RFA-AI-17-014 “Partnerships for Development of Clinically Useful Diagnostics for Antimicrobial-Resistant Bacteria (R01)” will develop a rapid, sensitive, and specific diagnostic platform for the culture-independent identification and determination of antimicrobial susceptibility and/or resistance of bacterial pathogens. The indiscriminate use and misuse of antibiotics has led to an impending global health crisis: the development of widespread antibiotic resistance. Bloodstream infections (BSI) are particularly significant with respect to their clinical impact: Severe sepsis strikes more than one million Americans every year, and 15 to 30 percent of those people die. In the absence of a rapid and reliable antibiotic susceptibility test (AST), health care providers often resort to broad-spectrum antibiotics, further escalating the development of drug-resistant strains. Halting the emergence and spread of antibiotic resistant organisms and providing appropriate life-saving therapy requires point-of-care (POC) diagnostics that can rapidly measure the drug susceptibility of a pathogen directly from clinical samples, eliminating the lengthy current procedures that require microbial growth. This project addresses a critical unmet need for rapid diagnostics that can both identify and determine the antimicrobial resistance profile of microbial pathogens. To address this problem, we propose to develop a combination of highly innovative technologies to (1) concentrate viable, low-abundance pathogens directly from blood without a culture step; (2) demonstrate the compatibility of the enrichment technology with the rapid and specific multiplexed detection of pathogens; (3) validate the compatibility of enrichment with an innovative, digital method of determining phenotypic antibiotic susceptibility; and (4) demonstrate that the entire workflow of pathogen concentration, identification, and phenotypic antibiotic susceptibility testing can be achieved in under 2 hours directly from human blood. This multidisciplinary project will be carried out by a highly experienced industrial research team with outstanding academic and clinical collaborators, and will create a new paradigm in diagnosis and treatment of bloodstream infections directly from clinical samples at the point- of-care. Countless lives will be saved and the spread of antibiotic resistance will be halted.

项目摘要 该项目“通过快速富集，识别和表型抗生素敏感性测试进行诊断 根据RFA-AI-17-014提交的病原体，“开发临床有用的合作伙伴关系 抗菌细菌（R01）的诊断”将发展快速，敏感和特定的诊断 独立鉴定和确定抗菌敏感性和/或确定的平台 细菌病原体的抗性。抗生素的不加区分使用和错过导致了即将来临的 全球健康危机：宽度抗生素耐药性的发展。血液感染（BSI）是 在其临床影响方面特别重要：严重的败血症超过一百万 每年美国人，其中15％至30％的人死亡。在没有快速可靠的情况下 抗生素易感性测试（AST），医疗保健提供者经常诉诸广谱抗生素，进一步 升级耐药菌株的发展。停止抗生素抗性的出现和扩散 有机体和提供适当的救生疗法需要护理点（POC）诊断，可以 直接从临床样本中直接测量病原体的药物敏感性，消除了长度 需要微生物生长的当前程序。 该项目解决了对快速诊断的关键未满足的需求，既可以识别并确定 微生物病原体的抗菌素抗性。为了解决这个问题，我们建议开发一个 高度创新技术与（1）直接从 没有文化步骤的血液； （2）证明富集技术与快速和快速的兼容性 病原体的特定多路复用检测； （3）验证富集与创新的兼容性， 确定表型抗生素易感性的数字方法； （4）证明了整个工作流程 可以在病原体浓度，鉴定和表型抗生素易感性测试中实现 直接距人类血液2小时。这个多学科项目将由高度 经验丰富的工业研究团队，拥有出色的学术和临床合作者，并将创建一个 直接从临床样本中直接从诊断和治疗血液感染的新范式 保养。将挽救无数的生命，并将停止抗生素耐药性的传播。