Novel molecular platforms are available for identifying (ID) the causative agents of microbial infections and generating antimicrobial susceptibility testing (AST) profiles, which can inform the suitable course of treatment. Many methods claim to perform AST in minutes or hours, often ignoring the need for time-consuming steps such as enrichment cultures and isolation of pure cultures. In clinical microbiology laboratories, an infectious microbial must first be cultured (overnight to days) and identified at the species level, followed by a subsequent AST with an additional turnaround time of 12–48 h due to the need for regrowth of the organism in the absence and presence of relevant antibiotics. Here, we present an electrochemical-based direct-from-specimen ID/AST method for reporting directly from unprocessed urine and blood in hours. In a limit of detection study of 0.5-ml whole blood samples for point-of-care and pediatric applications, 16.7% (4/24) of samples contrived at 2 CFU/ml and 100% (24/24) of samples contrived at 6 CFU/ml were reported positive in 6.5 h, indicating a limit of detection of 6 CFU/ml. In a separate direct-from-specimen AST study, the categorical susceptibility was reported correctly for blinded susceptible, intermediate, resistant, and polymicrobial contrived specimens in 4 h.

新型分子平台可用于识别 (ID) 微生物感染的病原体并生成抗菌药物敏感性测试 (AST) 谱，从而为合适的治疗过程提供信息。许多方法声称可以在几分钟或几小时内完成 AST，通常忽略了耗时步骤的需要，例如富集培养物和分离纯培养物。在临床微生物学实验室中，必须首先培养传染性微生物（过夜到数天）并在物种水平上进行鉴定，然后进行后续的 AST，由于需要在环境中重新生长微生物，因此需要 12-48 小时的额外周转时间。相关抗生素的存在和不存在。在这里，我们提出了一种基于电化学的直接样本 ID/AST 方法，可在数小时内直接从未经处理的尿液和血液中进行报告。在用于即时护理和儿科应用的 0.5 ml 全血样本的检测限研究中，16.7% (4/24) 的样本以 2 CFU/ml 的浓度设计，100% (24/24) 的样本以 2 CFU/ml 的浓度设计6.5 小时内报告阳性为 6 CFU/ml，表明检测限为 6 CFU/ml。在一项单独的直接样本 AST 研究中，在 4 小时内正确报告了盲法易感样本、中间样本、耐药样本和多种微生物人工样本的分类敏感性。