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FilmArray多重PCR系统在血流感染中的诊断准确性及临床影响:在三级医疗环境中与传统方法的比较研究

Diagnostic accuracy and clinical impact of filmarray multiplex PCR system in bloodstream infections: A comparative study with conventional methods in a tertiary health care setting.

作者信息

Aygar İsmail Selçuk, Hoşbul Tuğrul

机构信息

Medical Microbiology Laboratory, Gulhane Training and Research Hospital, Health Sciences University, Ankara, Keçiören, Türkiye.

Department of Medical Microbiology, Health Sciences University Gulhane Faculty of Medicine, Ankara, Türkiye.

出版信息

Medicine (Baltimore). 2025 Jul 18;104(29):e43263. doi: 10.1097/MD.0000000000043263.

DOI:10.1097/MD.0000000000043263
PMID:40696646
Abstract

The prompt identification of the causative microorganism responsible for bloodstream infections (BSIs) is paramount, as is the determination of its resistance profile. The aim of this study was to evaluate the diagnostic performance of the BioFire FilmArray Blood Culture Identification 2 (BCID2) panel for BSIs compared to conventional methods (CTMs) and its impact on antimicrobial treatment decisions. The study included 93 positive blood cultures from 85 patients with suspected BSI between January and August 2024. The BCID2 system demonstrated an accuracy of 90.32% in identifying positive samples in culture. The analytical sensitivity was calculated to be 83.72%, while the clinical sensitivity was determined to be 77.41% at the sample level. The highest concordance at the isolate level was observed for Klebsiella pneumoniae, Serratia marcescens, and Acinetobacter baumannii, with a 100% concordance rate. The compatibility of the method with conventional techniques was found in 85.13% of monomicrobial samples and 47.36% of polymicrobial samples. The mean time to result was determined as 1 day and 4 hours for BCID2 and 2 days and 4 hours for CTMs to identification; the difference was found to be significant. With regard to the detection of antimicrobial resistance genes, a 73.46% concordance was observed between BCID2 and conventional phenotypic methods at the sample level. While the presence of resistance was detected phenotypically in A. baumannii isolates, this could not be demonstrated genotypically with BCID2. In treatment simulations for antimicrobial stewardship, 91.5% of correct treatment arrangements were achieved according to the Norwegian guideline. Furthermore, an examination of the impact of gram stain pattern on diagnostic agreement revealed 90% agreement in anaerobic bottles, 77.77% in pediatric bottles, and 73.43% in aerobic bottles. However, these differences were not found to be statistically significant. Conversely, a significant difference in agreement rates was observed according to gram stain pattern, with 94.1% agreement observed in gram-positive cocci and 79.1% in gram-negative bacilli, yielding a statistically significant difference. BCID2 has the potential to improve clinical decision-making processes in the management of BSIs with its rapid diagnosis time, high specificity, and resistance detection capacity; however, due to its current limitations, it is currently best used as a supportive tool to CTMs.

摘要

及时鉴定出血流感染(BSIs)的致病微生物至关重要,确定其耐药谱也同样重要。本研究的目的是评估BioFire FilmArray血培养鉴定2(BCID2)检测板相对于传统方法(CTMs)对BSIs的诊断性能及其对抗菌治疗决策的影响。该研究纳入了2024年1月至8月期间85例疑似BSI患者的93份阳性血培养样本。BCID2系统在鉴定培养中的阳性样本时准确率为90.32%。计算得出分析灵敏度为83.72%,而在样本水平上临床灵敏度为77.41%。在分离株水平上,肺炎克雷伯菌、粘质沙雷菌和鲍曼不动杆菌的一致性最高,一致率为100%。在85.13%的单微生物样本和47.36%的多微生物样本中发现该方法与传统技术兼容。确定BCID2鉴定的平均出结果时间为1天4小时,CTMs为2天4小时;发现差异具有统计学意义。关于抗菌耐药基因检测方面,在样本水平上BCID2与传统表型方法之间的一致性为73.46%。虽然在鲍曼不动杆菌分离株中表型检测到耐药性,但BCID2无法在基因水平上证实。在抗菌管理的治疗模拟中,根据挪威指南,91.5%的治疗安排是正确的。此外,对革兰氏染色模式对诊断一致性影响的检查显示,厌氧瓶中的一致性为90%,儿科瓶中为77.77%,需氧瓶中为73.43%。然而,这些差异未发现具有统计学意义。相反,根据革兰氏染色模式观察到一致率存在显著差异,革兰氏阳性球菌中的一致率为94.1%,革兰氏阴性杆菌中为79.1%,差异具有统计学意义。BCID2凭借其快速的诊断时间、高特异性和耐药性检测能力,有潜力改善BSIs管理中的临床决策过程;然而,由于其目前的局限性,目前最好用作CTMs的辅助工具。

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Rev Assoc Med Bras (1992). 2024 Dec 16;70(12):e20241038. doi: 10.1590/1806-9282.20241038. eCollection 2024.
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Reduced mortality with antimicrobial stewardship guided by BioFire FilmArray Blood Culture Identification 2 panel in critically ill patients with bloodstream infection: A retrospective propensity score-matched study.血培养鉴定 2 panel 联合抗菌药物管理降低血流感染危重症患者死亡率:一项回顾性倾向评分匹配研究。
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FilmArray (BCID2) provides essential and timely results in bloodstream infections in small acute care hospitals without conventional microbiology services.FilmArray (BCID2) 在没有常规微生物服务的小型急性护理医院中提供重要且及时的血流感染结果。
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Multicenter Evaluation of the FilmArray Blood Culture Identification 2 Panel for Pathogen Detection in Bloodstream Infections.多中心评估 FilmArray 血培养鉴定 2 面板在血流感染病原体检测中的应用。
Microbiol Spectr. 2023 Feb 14;11(1):e0254722. doi: 10.1128/spectrum.02547-22. Epub 2022 Dec 15.
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