Rapid Microbial ID Direct From Specimen

直接从样本进行快速微生物鉴定

• 批准号: 10699890
• 负责人: ERIK J NILSSON
• 金额: $ 27.57万
• 依托单位: PATAIGIN, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-14 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10699890
• 关键词: Adverse event; Affect; Antibiotics; Antimicrobial Resistance; Antimicrobial susceptibility; Bacteremia; Bacteria; Bacteriuria; Baltimore; Biological Assay; Biotechnology; Blood; Candida; Cessation of life; Clinical; Collaborations; Computing Methodologies; Data Analyses; Detection; Development; Diagnosis; Experimental Designs; Goals; Gram-Negative Bacteria; Gram-Positive Bacteria; Health; Hospitals; Hour; Incidence; Industrialization; Infection; Intervention; Laboratories; Letters; Life; Lipid A; Lipids; Maryland; Measures; Medical; Medical center; Membrane Lipids; Methods; Microbiology; Mycoses; Organism; Patients; Performance; Persons; Prevention; Price; Privatization; Public Health; Reagent; Reflex action; Research; Research Personnel; Research Proposals; Risk; Sampling; Sepsis; Specimen; Speed; Testing; Time; Universities; Urine; antimicrobial; antimicrobial drug; cost effective; effective therapy; fungus; innovation; invention; medical schools; method development; microbial; microbial colonization; mortality; pathogen; pathogenic fungus; prototype; rapid technique; research clinical testing

Abstract This proposal is for BACLIB, a cost-effective, one hour microbial ID test direct from a clinical specimen or positive blood culture. Microbial ID testing is an essential step to appropriate antimicrobial treatment. Today, positive microbial culture indicates a microbial infection, and subsequent microbial ID testing on cultured samples identifies species. Microbial cultures typically take a day to turn positive. During this period, clinicians must treat patients empirically, delaying appropriate therapy, and increasing the risk of sepsis and other adverse events. We have developed BACLIB, a one-hour test that identifies microbial infections directly from positive blood culture (PBC) or urine specimens. BACLIB measures species-specific microbial membrane lipids: lipid A in Gram-negative bacteria, and analogous lipids in Gram-positive bacteria and fungi. These lipids are abundant, easily extracted, and more sensitively detected and identified than analytes used by current tests. In preliminary results with clinical PBC specimens, BACLIB correctly identified 93% of samples. The only available rapid ID test for PBC correctly identified only 61% of these same samples. Thus, BACLIB offers significant advantages over available tests for positive blood culture. BACLIB shows similar performance direct from urine specimens, where there is currently no approved direct-from-specimen ID test. In this proposal, we develop a prototype clinical assay based on BACLIB. The prototype will be evaluated on clinical and prepared specimens and compared with standard methods. The research approach is as follows: Specific Aim 1: Pathogen ID Direct From Specimen. In this aim we identify pathogens direct from PBC and urine using BACLIB. Specific Aim 2. Quantitation of Pathogens Direct From Urine. In this aim we measure the quantity of pathogens in urine, to determine positive urine specimens, defined by microbial concentration. Specific Aim 3. Polymicrobial Specimens. In this aim we evaluate BACLIB in identifying species in clinical and prepared polymicrobial PBC and urine specimens. Appropriate antimicrobial therapy is essential to effective treatment of bacteriuria and bacteremia, and to prevention and treatment of sepsis. These conditions remain major health problems. Furthermore, in the case of sepsis progression is often rapid, so that a single hour saved in diagnosis time can significantly reduce mortality. Faster tests are therefore needed to save lives.

抽象的 该建议是针对Baclib的，Baclib是一种直接从临床标本或阳性血液的成本效益，一小时的微生物ID测试 文化。 微生物ID测试是适当的抗菌治疗的重要步骤。今天，阳性微生物培养 指示微生物感染，随后对培养样品进行的微生物ID测试确定了物种。微生物 文化通常需要一天的时间才能变为积极。在此期间，临床医生必须经验治疗患者，延迟 适当的治疗，并增加败血症和其他不良事件的风险。 我们已经开发了Baclib，这是一种一小时的测试，它直接从阳性血液培养（PBC）中鉴定出微生物感染。 或尿液标本。 Baclib测量物种特异性的微生物膜脂质：革兰氏阴性细菌中的脂质A和 革兰氏阳性细菌和真菌中的类似脂质。这些脂质丰富，易于提取，更敏感 比当前测试所使用的分析物检测和鉴定。 在临床PBC标本的初步结果中，Baclib正确识别了93％的样品。唯一可用的快速ID 正确识别PBC的测试只有61％的相同样品。因此，巴克利布提供了重要的优势 可用的血液培养测试。巴克里布从尿液标本中显示出相似的性能，其中有 目前尚未获得批准的直接访问特语ID测试。 在此提案中，我们开发了基于Baclib的原型临床测定。原型将在临床和 准备的标本并将其与标准方法进行比较。 研究方法如下： 特定目标1：直接从样品中直接的病原体ID。在此目标中，我们使用PBC直接识别病原体 巴克里布。 特定目的2。直接从尿液中定量病原体。在此目标中，我们测量了病原体的数量 尿液，确定由微生物浓度定义的尿液标本。 特定目的3。多数型标本。在此目的中，我们评估了识别临床和制备物种的Baclib 多因素PBC和尿液标本。 适当的抗菌治疗对于有效治疗细菌和菌血症和预防是必不可少的 和败血症的治疗。这些情况仍然是主要的健康问题。此外，在败血症的情况下 通常很快，因此在诊断时间节省的一个小时可以显着降低死亡率。因此，测试更快 需要挽救生命。