FAST platform for same-shift, complete antibiotic menu antibiotic susceptibility testing

用于同班、完整抗生素菜单抗生素敏感性测试的 FAST 平台

• 批准号: 9464993
• 负责人: ERIC STERN
• 金额: $ 29.89万
• 依托单位: SELUX DIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9464993
• 关键词: Agreement; Algorithm Design; Algorithms; Amplifiers; Antibiotic Resistance; Antibiotic Therapy; Antibiotic susceptibility; Antibiotics; Bacterial Antibiotic Resistance; Biological Assay; Blinded; Blood; Centers for Disease Control and Prevention (U.S.); Chemicals; Clinical; Clinical Medicine; Clinical Microbiology; Combating Antibiotic Resistant Bacteria; Communicable Diseases; Detection; Development; Devices; Diagnostic; End Point Assay; Engineering; Ensure; Epidemic; Escherichia coli; Funding; Goals; Grant; Healthcare; Hour; Human; In Vitro; Infection; Institutes; Invaded; Laboratories; Length of Stay; Machine Learning; Metabolic; Methods; Microbiology; Minimum Inhibitory Concentration measurement; Optics; Pathogenicity; Patient Care; Patients; Phase; Phenotype; Plague; Positioning Attribute; Privatization; Quality of Care; Reagent; Recovery; Regulatory Affairs; Sampling; Sampling Studies; Scientist; Small Business Innovation Research Grant; Speed; Staphylococcus aureus; System; Test Result; Testing; Vancomycin; Work; accurate diagnosis; base; clinically relevant; combat; commercialization; cost; cost effectiveness; design; detector; individual patient; instrument; nanosensors; novel; optimal treatments; pathogen; performance tests; prediction algorithm; prototype; rapid diagnosis

The goal of this Phase I SBIR proposal is to demonstrate utility to all major pathogenic bacterial strains of SeLux’s rapid, low-cost, phenotypic antibiotic susceptibility test (AST) system (fast-AST or FAST). Utilizing existing optical detectors and standard dried antibiotic microplates, and avoiding pitfalls of metabolic probes, FAST will potentially transform therapy of infections by significantly accelerating AST, thereby facilitating treatment with the optimal antibiotic. Aim 1 will apply FAST to hundreds of samples of pathogenic bacterial strains, while developing and optimizing a predictive algorithm for clinical utility. Aim 2 will extend the FAST platform to slow-growing strains and species as well. SeLux has demonstrated FAST to exceed FDA 510(k) requirements for minimum inhibitory concentration determinations for 25+ strains of Staphylococcus aureus and Escherichia coli with full antibiotic panels. Completion of the proposed aims will expand FAST to all major clinically-relevant, non-fastidious bacterial pathogens. SeLux’s interdisciplinary team has expertise in nanosensing, microbiology, and algorithm design and is buttressed by distinguished experts in Clinical Microbiology, Infectious Disease, and Machine Learning.

第一阶段SBIR提案的目标是证明对所有主要致病性 SeLux快速、低成本、表型抗生素敏感性试验的菌株 (AST)系统（FAST或FAST）。利用现有的光学探测器和标准干燥 抗生素微孔板，并避免代谢探针的陷阱，FAST将有可能改变 通过显著加速AST治疗感染，从而促进用 最佳抗生素目标1将把FAST应用于数百个致病细菌菌株的样本， 同时开发和优化用于临床应用的预测算法。目标2将扩大 FAST平台也适用于生长缓慢的菌株和物种。SeLux已经证明FAST可以 超过FDA 510（k）对25+的最低抑菌浓度测定的要求 金黄色葡萄球菌和大肠杆菌菌株，并配有完整的抗生素面板。完成 拟议的目标是将FAST扩展到所有主要的临床相关的非苛养细菌， 病原体SeLux的跨学科团队拥有纳米传感，微生物学和 算法设计，并得到临床微生物学、感染学和 疾病和机器学习。