Current methods for the diagnosis of urinary tract infections with antimicrobial susceptibility testing take 2–3 days and require a clinical laboratory. The lack of a rapid, point-of-care antibiotic susceptibility test (AST) has contributed to the misuse of antibiotics when treating urinary tract infections (UTIs) and consequently to the rise of multi-drug-resistant organisms. The current clinical approach has led to reduced treatment options and increased costs of diagnosis and therapy. To address this issue, novel diagnostics are needed for the timely determination of antimicrobial susceptibility. We present a rapid, point-of-care, phenotypic AST device that can report the antibiotic susceptibility/resistance of a uropathogen to a panel of antibiotics in as few as 3 h by utilizing fluorescent-labelling chemistry and a highly sensitive particle-counting instrument. We analysed 744 urine samples from the outpatients and inpatients of two Italian hospitals. The 130 UTI-positive patient urine samples we found were measured using a panel of six common UTI antibiotics plus a growth control. By comparing our results to hospital laboratory urine cultures, we obtained an overall sensitivity = 81%, a specificity = 83%, an SPV (sensitivity predicted value) = 95%, and an RPV (resistance predicted value) = 54%. According to our preliminary data, the sensitivity predicted value for a single antibiotic agent was 95%, thus allowing (in the vast majority of cases) an early (within 3 h) recognition of an effective agent for a single patient.

中文翻译：

---

细菌感染诊断和 3 小时抗生素处方作为抗生素耐药性的答案：尿路感染案例

目前通过抗菌药物敏感性测试诊断尿路感染的方法需要 2-3 天，并且需要临床实验室。缺乏快速、即时的抗生素药敏试验 (AST) 已导致在治疗尿路感染 (UTI) 时滥用抗生素，从而导致多重耐药菌的兴起。目前的临床方法导致治疗选择减少，诊断和治疗成本增加。为了解决这个问题，需要新的诊断方法来及时确定抗菌药物敏感性。我们提供快速、即时、表型 AST 装置可以通过利用荧光标记化学和高度灵敏的粒子计数仪器在短短 3 小时内向一组抗生素报告尿路病原体的抗生素敏感性/耐药性。我们分析了来自意大利两家医院门诊和住院患者的 744 份尿液样本。我们发现的 130 个 UTI 阳性患者尿液样本是使用一组六种常见 UTI 抗生素和生长对照进行测量的。通过将我们的结果与医院实验室尿培养进行比较，我们获得了总体敏感性 = 81%、特异性 = 83%、SPV（敏感性预测值）= 95% 和 RPV（耐药性预测值）= 54%。根据我们的初步数据，单​​一抗生素药物的敏感性预测值为 95%，