Abstract：
OBJECTIVE: This study compared the results of the new Sysmex PA-100 AST System, a point-of-care analyser, with routine microbiology for the detection of urinary tract infections (UTI) and performance of antimicrobial susceptibility tests (AST) directly from urine.
METHODS: Native urine samples from 278 female patients with suspected uncomplicated UTI were tested in the Sysmex PA-100 and with reference methods of routine microbiology: urine culture for bacteriuria and disc diffusion for AST.
RESULTS: The analyser delivered bacteriuria results in 15 min and AST results within 45 min. Sensitivity and specificity for detection of microbiologically confirmed bacteriuria were 84.0% (89/106; 95% CI: 75.6-90.4%) and 99.4% (155/156; 95% CI: 96.5-100%), respectively, for bacterial species within the analyser specifications. These are Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecalis and Staphylococcus saprophyticus, which are common species causing uncomplicated UTI. Overall categorical agreement (OCA) for AST results for the five antimicrobials tested in the Sysmex PA-100 (amoxicillin/clavulanic acid, ciprofloxacin, fosfomycin, nitrofurantoin and trimethoprim) ranged from 85.4% (70/82; 95%CI: 75.9-92.2%) for ciprofloxacin to 96.4% (81/84; 95% CI: 89.9-99.3%) for trimethoprim. The Sysmex PA-100 provided an optimal treatment recommendation in 218/278 cases (78.4%), against 162/278 (58.3%) of clinical decisions.
CONCLUSIONS: This first clinical evaluation of the Sysmex PA-100 in a near-patient setting demonstrated that the analyser delivers phenotypic AST results within 45 min, which could enable rapid initiation of the correct targeted treatment with no further adjustment needed. The Sysmex PA-100 has the potential to significantly reduce ineffective or unnecessary antibiotic prescription in patients with UTI symptoms.
METHODS: Native urine samples from 278 female patients with suspected uncomplicated UTI were tested in the Sysmex PA-100 and with reference methods of routine microbiology: urine culture for bacteriuria and disc diffusion for AST.
RESULTS: The analyser delivered bacteriuria results in 15 min and AST results within 45 min. Sensitivity and specificity for detection of microbiologically confirmed bacteriuria were 84.0% (89/106; 95% CI: 75.6-90.4%) and 99.4% (155/156; 95% CI: 96.5-100%), respectively, for bacterial species within the analyser specifications. These are Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Enterococcus faecalis and Staphylococcus saprophyticus, which are common species causing uncomplicated UTI. Overall categorical agreement (OCA) for AST results for the five antimicrobials tested in the Sysmex PA-100 (amoxicillin/clavulanic acid, ciprofloxacin, fosfomycin, nitrofurantoin and trimethoprim) ranged from 85.4% (70/82; 95%CI: 75.9-92.2%) for ciprofloxacin to 96.4% (81/84; 95% CI: 89.9-99.3%) for trimethoprim. The Sysmex PA-100 provided an optimal treatment recommendation in 218/278 cases (78.4%), against 162/278 (58.3%) of clinical decisions.
CONCLUSIONS: This first clinical evaluation of the Sysmex PA-100 in a near-patient setting demonstrated that the analyser delivers phenotypic AST results within 45 min, which could enable rapid initiation of the correct targeted treatment with no further adjustment needed. The Sysmex PA-100 has the potential to significantly reduce ineffective or unnecessary antibiotic prescription in patients with UTI symptoms.
摘要：
目的：本研究比较了新的SysmexPA-100AST系统的结果，现场护理分析仪，使用常规微生物学技术直接从尿液中检测尿路感染（UTI）和抗菌药物敏感性试验（AST）。
方法：在SysmexPA-100中测试了来自278名疑似无并发症UTI的女性患者的天然尿液样本，并采用常规微生物学的参考方法：尿培养的细菌尿和AST的椎间盘扩散。
结果：分析仪在15分钟内提供了菌尿结果，在45分钟内提供了AST结果。微生物学证实的菌尿检测的敏感性和特异性分别为84.0%(89/106;95%CI:75.6-90.4%)和99.4%(155/156;95%CI:96.5-100%),分别,用于分析仪规范内的细菌种类。这些是大肠杆菌，肺炎克雷伯菌,变形杆菌,粪肠球菌和腐生葡萄球菌，这是常见的物种导致简单的UTI。SysmexPA-100（阿莫西林/克拉维酸，环丙沙星,磷霉素,呋喃妥因和甲氧苄啶)范围从环丙沙星的85.4%(70/82;95CI:75.9-92.2%)到甲氧苄啶的96.4%(81/84;95%CI:89.9-99.3%)。SysmexPA-100在218/278例（78.4％）中提供了最佳治疗建议，与162/278（58.3%）的临床决策相反。
结论：在患者附近对SysmexPA-100进行的首次临床评估表明，分析仪在45分钟内提供了表型AST结果，这可以快速启动正确的靶向治疗，而无需进一步调整。SysmexPA-100具有显着减少UTI症状患者无效或不必要的抗生素处方的潜力。
方法：在SysmexPA-100中测试了来自278名疑似无并发症UTI的女性患者的天然尿液样本，并采用常规微生物学的参考方法：尿培养的细菌尿和AST的椎间盘扩散。
结果：分析仪在15分钟内提供了菌尿结果，在45分钟内提供了AST结果。微生物学证实的菌尿检测的敏感性和特异性分别为84.0%(89/106;95%CI:75.6-90.4%)和99.4%(155/156;95%CI:96.5-100%),分别,用于分析仪规范内的细菌种类。这些是大肠杆菌，肺炎克雷伯菌,变形杆菌,粪肠球菌和腐生葡萄球菌，这是常见的物种导致简单的UTI。SysmexPA-100（阿莫西林/克拉维酸，环丙沙星,磷霉素,呋喃妥因和甲氧苄啶)范围从环丙沙星的85.4%(70/82;95CI:75.9-92.2%)到甲氧苄啶的96.4%(81/84;95%CI:89.9-99.3%)。SysmexPA-100在218/278例（78.4％）中提供了最佳治疗建议，与162/278（58.3%）的临床决策相反。
结论：在患者附近对SysmexPA-100进行的首次临床评估表明，分析仪在45分钟内提供了表型AST结果，这可以快速启动正确的靶向治疗，而无需进一步调整。SysmexPA-100具有显着减少UTI症状患者无效或不必要的抗生素处方的潜力。
