Morecchiato Fabio, Chilleri Chiara, Antonelli Alberto, Malmberg Christer, Giani Tommaso, Rossolini Gian Maria
Department of Experimental and Clinical Medicine, University of Florence, Florence, Tuscany, Italy.
Microbiology and Virology Unit, Careggi University Hospital, Florence, Tuscany, Italy.
Microbiol Spectr. 2025 Jul;13(7):e0037025. doi: 10.1128/spectrum.00370-25. Epub 2025 Jun 10.
The accuracy and turnaround time (TAT) of the QuickMIC system (QMIC) for rapid antimicrobial susceptibility testing (AST) of Gram-negative pathogens from positive blood cultures were evaluated, in comparison with a standard-of-care workflow based on culture and AST with broth microdilution. Essential agreement (EA) and bias were evaluated according to the ISO 20776-2:2021, category agreement (CA), categorical overestimation (CO), and underestimation (CU) rates were evaluated according to the European Committee on Antimicrobial Susceptibility Testing(EUCAST) breakpoints, and major discrepancy (MD) and very major discrepancy (VMD) rates were evaluated according to the Food and Drug Administration (FDA) guidelines and breakpoints. QMIC yielded evaluable data for 103/118 blood cultures (87.3%), including Enterobacterales ( = 82), ( = 16), and complex ( = 5). Overall, 41 isolates (39.8%) were positive for extended-spectrum β-lactamases and/or carbapenemases. QMIC exhibited EA and CA values of 89.5% and 93.3%, respectively, with values <90% were reported for cefepime, meropenem, and piperacillin-tazobactam. Mean bias was -23.1%, with values >±30% observed with colistin and piperacillin-tazobactam. Overall, CO and CU were observed in 2.3% and 4.4% of cases. MD and VMD with FDA breakpoints were observed in 1.5% and 8.9% of cases, respectively. The lowest accuracy of QMIC in terms of CU was observed with cefepime, colistin, and gentamicin and in terms of VMD with ceftazidime-avibactam, meropenem, and piperacillin-tazobactam. The mean TAT for QMIC was 192 ± 18 min. QMIC demonstrated the potential for rapid AST, with a mean time to result of less than 4 hours, and an overall acceptable accuracy, except with some β-lactams. Further studies are warranted to assess the potential impact of QMIC implementation on clinical outcomes.IMPORTANCEThe introduction of rapid antimicrobial susceptibility testing (AST) systems for positive blood cultures (BCs) is one of the most promising technological advancements to improve bloodstream infections diagnosis, by providing faster results useful for antimicrobial stewardship. The value of such systems is expected to be higher in settings of high endemicity of antimicrobial resistance, where phenotype prediction is more difficult, and rates of inaccurate empirical therapies are expected to be higher. In this study, we investigated the accuracy and turnaround time (TAT) of a new rapid AST system for positive BCs, in comparison with a standard-of-care workflow based on broth microdilution, including several cases positive for extended-spectrum β-lactamase- and/or carbapenemase-producing Gram negatives. TAT was 192 ± 18 min, and a good accuracy was observed for testing some agents (amikacin, gentamicin, ciprofloxacin, colistin, and ceftazidime-avibactam) but a lower accuracy for testing other agents (cefepime, meropenem, and piperacillin-tazobactam). Further assessment of this technology, after improving accuracy, is warranted to evaluate the clinical impact.
对QuickMIC系统(QMIC)用于从阳性血培养物中快速检测革兰氏阴性病原体抗菌药物敏感性(AST)的准确性和周转时间(TAT)进行了评估,并与基于肉汤微量稀释培养和AST的标准治疗流程进行比较。根据ISO 20776-2:2021评估基本一致性(EA)和偏差,根据欧洲抗菌药物敏感性测试委员会(EUCAST)的断点评估类别一致性(CA)、类别高估(CO)和低估(CU)率,根据美国食品药品监督管理局(FDA)的指南和断点评估主要差异(MD)和非常主要差异(VMD)率。QMIC对118份血培养物中的103份(87.3%)得出了可评估数据,包括肠杆菌科细菌(n = 82)、不动杆菌属(n = 16)和嗜麦芽窄食单胞菌属(n = 5)。总体而言,41株分离菌(39.8%)产超广谱β-内酰胺酶和/或碳青霉烯酶呈阳性。QMIC的EA和CA值分别为89.5%和93.3%,头孢吡肟、美罗培南和哌拉西林-他唑巴坦的EA值<90%。平均偏差为-23.1%,黏菌素和哌拉西林-他唑巴坦的偏差值>±30%。总体而言,2.3%的病例观察到CO,4.4%的病例观察到CU。根据FDA断点,MD和VMD分别在1.5%和8.9%的病例中观察到。QMIC在CU方面准确性最低的是头孢吡肟、黏菌素和庆大霉素,在VMD方面准确性最低的是头孢他啶-阿维巴坦、美罗培南和哌拉西林-他唑巴坦。QMIC的平均TAT为192±18分钟。QMIC显示出快速AST的潜力,平均报告结果时间少于4小时,除了一些β-内酰胺类药物外,总体准确性可接受。有必要进一步研究以评估实施QMIC对临床结果的潜在影响。
重要性
引入用于阳性血培养物(BC)的快速抗菌药物敏感性测试(AST)系统是改善血流感染诊断最有前景的技术进步之一,通过提供对抗菌药物管理有用的更快结果。在抗菌药物耐药性高流行地区,这种系统的价值预计更高,在这些地区表型预测更困难,经验性治疗不准确的发生率预计更高。在本研究中,我们调查了一种用于阳性BC的新型快速AST系统的准确性和周转时间(TAT),并与基于肉汤微量稀释的标准治疗流程进行比较,包括几例产超广谱β-内酰胺酶和/或碳青霉烯酶的革兰氏阴性菌阳性病例。TAT为192±18分钟,检测某些药物(阿米卡星、庆大霉素、环丙沙星、黏菌素和头孢他啶-阿维巴坦)时观察到良好的准确性,但检测其他药物(头孢吡肟、美罗培南和哌拉西林-他唑巴坦)时准确性较低。在提高准确性后,有必要对该技术进行进一步评估以评估其临床影响。