Rapid Microbial ID Direct From Specimen

摘要 这项建议是针对BACLIB的，这是一种经济高效的一小时微生物ID测试，直接从临床样本或阳性血液中提取 文化。 微生物ID检测是进行适当的抗菌治疗的必要步骤。今天，阳性微生物培养 表明存在微生物感染，随后对培养样本进行的微生物ID检测确定了物种。微生物 文化培养通常需要一天时间才能转为阳性。在此期间，临床医生必须对患者进行经验性治疗，从而推迟 适当的治疗，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，可以直接从阳性血培养(PBC)中识别微生物感染 或者尿液样本。BACLIB测量特定物种的微生物膜脂：革兰氏阴性细菌中的类脂A，以及 革兰氏阳性细菌和真菌中类似的脂类。这些脂类丰富，容易提取，而且更敏感。 比当前测试使用的分析物更能被检测和识别。 在临床PBC样本的初步结果中，BACLIB正确识别了93%的样本。唯一可用的快速ID PBC检测只正确识别了这些相同样本中的61%。因此，BACLIB具有显著的优势 血液培养呈阳性的可用检测。BACLIB直接从尿样中显示出类似的表现，在那里有 目前还没有批准的直接从样本中提取的ID测试。 在这个方案中，我们开发了一个基于BACLIB的原型临床试验。该原型将在临床和临床上进行评估 制备样品，并与标准方法进行比较。 研究方法如下： 具体目标1：直接从标本中识别病原体。在这个目标中，我们直接从PBC和尿液中鉴定病原体 BACLIB. 具体目标2.直接从尿液中定量检测病原体。在这个目标中，我们测量了病原体的数量 尿液，以确定阳性尿液标本，以微生物浓度定义。 具体目标3.多菌种标本。为此，我们评估了BACLIB在临床和制剂中鉴定物种的价值 多菌PBC和尿液标本。 适当的抗菌治疗是有效治疗菌尿和菌血症以及预防的关键。 和脓毒症的治疗。这些情况仍然是主要的健康问题。此外，在脓毒症进展的情况下 通常是快速的，因此在诊断时间上节省一个小时就可以显著降低死亡率。因此，测试速度更快 需要拯救生命。

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.