Patients’ characteristics.

Bacterial resistance to antimicrobials is considered a major issue worldwide. This condition may account for treatment failure of urinary tract infections, which are among the most common infections both in community and healthcare settings. Therapy against uropathogens is generally administered empirically, possibly leading to unsuccessful therapy, recurrence and development of antibiotic resistance. The reduction in analytical time to obtain antimicrobial susceptibility test (AST) results could play a key role in reducing the cost of healthcare, providing information about antibiotic efficacy and thus preventing from either exploiting new and expensive antibiotics unnecessarily or using obsolete and ineffective ones. A more rational choice among treatment options would hence lead to more effective treatment and faster resolution. In this paper we evaluated the performance of a new Point Of Care Test (POCT) for the rapid prediction of antimicrobial susceptibility in urine samples performed without the need of a laboratory or specialized technicians. 349 patients were enrolled in two open-label, monocentric, non-interventional clinical trials in partnership with an Emergency Medicine ward and the Day Hospital of two large healthcare facilities in Rome. Antibiogram was carried out on 97 patients. Results from analysis of urine samples with the POCT were compared with those from routine AST performed on culture-positive samples, displaying high accuracy (>90%) for all tested antimicrobial drugs and yielding reliable results in less than 12 hours from urine collection thus reducing analytical and management costs.

细菌对抗菌药物的耐药性已被视为全球性重大公共卫生问题。此类耐药性可能导致尿路感染治疗失败，而尿路感染是社区与医疗环境中最常见的感染性疾病之一。针对尿路致病菌的治疗通常采用经验性给药方案，这可能会导致治疗失败、病情复发以及抗生素耐药性的进一步发展。缩短抗菌药物敏感性试验（antimicrobial susceptibility test, AST）结果的出具时间，对于降低医疗成本、明确抗生素的临床效用具有关键作用，进而可避免不必要地使用新型昂贵抗生素，或是使用过时无效的药物。因此，在治疗方案中做出更合理的选择，能够提升治疗效果并加速患者康复。本研究评估了一种新型床旁检测（Point Of Care Test, POCT）的性能，该检测无需实验室环境或专业技术人员操作，即可快速预测尿液样本中的抗菌药物敏感性。研究联合罗马两家大型医疗机构的急诊病房与日间医院，开展了两项开放标签、单中心、非干预性临床试验，共纳入349例患者。其中97例患者完成了药敏谱（antibiogram）检测。将该POCT对尿液样本的分析结果，与培养阳性样本的常规AST检测结果进行对比，结果显示，其对所有受试抗菌药物的检测准确率均超过90%，且可在尿液采集后12小时内出具可靠结果，从而降低了检测与管理成本。