Abstract：
BACKGROUND: Early identification of extended-spectrum ß-lactamase (ESBL) and carbapenemase-producing Enterobacterales (CP-CRE) is critical for timely therapy. Rapid phenotypic tests identifying these resistance mechanisms from pure bacterial colonies have been developed.
OBJECTIVE: To determine the operating characteristics of available rapid phenotypic tests when applied directly to positive blood cultures.
UNASSIGNED: Bivariate random effects models were used unless convergence was not achieved where we used separate univariate models for sensitivity and specificity.
METHODS: MEDLINE, CENTRAL, Embase, BIOSIS, and Scopus from inception to 16 March 2021.
METHODS: Studies using any rapid phenotypic assay for detection of ESBL or CP-CRE directly from blood cultures positive for Enterobacterales, including those utilizing spiked blood cultures. Case reports/series, posters, abstracts, review articles, those with ≤5 resistant isolates, and studies lacking data or without full text were excluded.
METHODS: Consecutive patient samples (main analysis) or spiked blood cultures (sensitivity analysis).
METHODS: Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry assays (MALDI-TOF) and commercially available chromogenic or immunogenic assays.
UNASSIGNED: Conventional laboratory methods and/or polymerase chain reaction (PCR).
UNASSIGNED: Quality Assessment of Diagnostic Accuracy Studies Version 2 (QUADAS-2).
RESULTS: For detection of the ESBL phenotype the respective pooled sensitivities and specificities for consecutive clinical samples were as follows: 94% (95% CI 93-99%) and 97% (95% CI 95-100%) for MALDI-TOF/mass spectrometry (n = 1); and 98% (95% CI 92-100%) and 100% (95% CI 96-100%) for chromogenic assays (n = 7). For the CP-CRE phenotype the respective pooled sensitivity and specificities for consecutive clinical samples were as follows: 100% (95% CI 99-100%) and 100% (95% CI 100-100%) for MALDI-TOF (n = 2); 96% (95% CI 77-99%) and 100% (95% CI 81-100%) for chromogenic assays (n = 4); and 98% (95% CI 96-100%) and 100% (95% CI 100-100%) for immunogenic testing (n = 2).
CONCLUSIONS: Rapid phenotypic assays that can be directly applied to positive blood cultures to detect ESBL and carbapenemase production from Enterobacterales exist and, although clinical studies are limited, they appear to have high sensitivity and specificity. Their potential to facilitate patient care through timely identification of bacterial resistance should be further explored.
OBJECTIVE: To determine the operating characteristics of available rapid phenotypic tests when applied directly to positive blood cultures.
UNASSIGNED: Bivariate random effects models were used unless convergence was not achieved where we used separate univariate models for sensitivity and specificity.
METHODS: MEDLINE, CENTRAL, Embase, BIOSIS, and Scopus from inception to 16 March 2021.
METHODS: Studies using any rapid phenotypic assay for detection of ESBL or CP-CRE directly from blood cultures positive for Enterobacterales, including those utilizing spiked blood cultures. Case reports/series, posters, abstracts, review articles, those with ≤5 resistant isolates, and studies lacking data or without full text were excluded.
METHODS: Consecutive patient samples (main analysis) or spiked blood cultures (sensitivity analysis).
METHODS: Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry assays (MALDI-TOF) and commercially available chromogenic or immunogenic assays.
UNASSIGNED: Conventional laboratory methods and/or polymerase chain reaction (PCR).
UNASSIGNED: Quality Assessment of Diagnostic Accuracy Studies Version 2 (QUADAS-2).
RESULTS: For detection of the ESBL phenotype the respective pooled sensitivities and specificities for consecutive clinical samples were as follows: 94% (95% CI 93-99%) and 97% (95% CI 95-100%) for MALDI-TOF/mass spectrometry (n = 1); and 98% (95% CI 92-100%) and 100% (95% CI 96-100%) for chromogenic assays (n = 7). For the CP-CRE phenotype the respective pooled sensitivity and specificities for consecutive clinical samples were as follows: 100% (95% CI 99-100%) and 100% (95% CI 100-100%) for MALDI-TOF (n = 2); 96% (95% CI 77-99%) and 100% (95% CI 81-100%) for chromogenic assays (n = 4); and 98% (95% CI 96-100%) and 100% (95% CI 100-100%) for immunogenic testing (n = 2).
CONCLUSIONS: Rapid phenotypic assays that can be directly applied to positive blood cultures to detect ESBL and carbapenemase production from Enterobacterales exist and, although clinical studies are limited, they appear to have high sensitivity and specificity. Their potential to facilitate patient care through timely identification of bacterial resistance should be further explored.
摘要：
背景：早期鉴定产超广谱β-内酰胺酶（ESBL）和产碳青霉烯酶肠杆菌（CP-CRE）对于及时治疗至关重要。已经开发了从纯细菌菌落中鉴定这些抗性机制的快速表型测试。
目的：确定直接应用于阳性血培养时可用的快速表型测试的操作特征。
方法：数据源：MEDLINE,中部,Embase,BIOSIS,和Scopus从成立到2021年3月16日。
方法：使用任何快速表型测定法直接从肠杆菌阳性的血培养物中检测ESBL或CP-CRE的研究，包括那些利用尖刺血培养的人。病例报告/系列，海报,摘要,评论文章,具有≤5个抗性分离株的人，缺乏数据或没有全文的研究被排除。
方法：连续患者样本（主要分析）或加标血培养（敏感性）。
方法：基质辅助激光解吸/电离飞行时间质谱测定（MALDI-TOF/MS）和市售显色或免疫原性测定。参考标准:常规实验室方法和/或PCR。偏差风险：QUADAS-2。
结果：使用双变量随机效应模型，除非我们使用单独的单变量模型进行敏感性和特异性，否则无法达到收敛。
结果：对于ESBL表型的检测，连续临床样品的合并敏感性和特异性分别为：MALDI-TOF/MS（n=1）的94％（95％CI93-99％）和97％（95％CI95-100％）；生色测定的98％（95％CI92-100％）和100％（95％CI96-100％）。对于CP-CRE表型，连续临床样品的相应合并敏感性和特异性为：对于MALDI-TOF（n=2）为100％（95％CI99-100％）和100％（95％CI100-100％）；显色测定（n=4）为96％（95％CI77-99％）和100％（95％CI81-100％）；对于98％（95％CI=100％）
结论：存在可直接应用于阳性血培养以检测肠杆菌产生的ESBL和碳青霉烯酶的快速表型测定，虽然临床研究有限，它们似乎具有很高的敏感性和特异性。应进一步探索它们通过及时识别细菌耐药性来促进患者护理的潜力。
目的：确定直接应用于阳性血培养时可用的快速表型测试的操作特征。
方法：数据源：MEDLINE,中部,Embase,BIOSIS,和Scopus从成立到2021年3月16日。
方法：使用任何快速表型测定法直接从肠杆菌阳性的血培养物中检测ESBL或CP-CRE的研究，包括那些利用尖刺血培养的人。病例报告/系列，海报,摘要,评论文章,具有≤5个抗性分离株的人，缺乏数据或没有全文的研究被排除。
方法：连续患者样本（主要分析）或加标血培养（敏感性）。
方法：基质辅助激光解吸/电离飞行时间质谱测定（MALDI-TOF/MS）和市售显色或免疫原性测定。参考标准:常规实验室方法和/或PCR。偏差风险：QUADAS-2。
结果：使用双变量随机效应模型，除非我们使用单独的单变量模型进行敏感性和特异性，否则无法达到收敛。
结果：对于ESBL表型的检测，连续临床样品的合并敏感性和特异性分别为：MALDI-TOF/MS（n=1）的94％（95％CI93-99％）和97％（95％CI95-100％）；生色测定的98％（95％CI92-100％）和100％（95％CI96-100％）。对于CP-CRE表型，连续临床样品的相应合并敏感性和特异性为：对于MALDI-TOF（n=2）为100％（95％CI99-100％）和100％（95％CI100-100％）；显色测定（n=4）为96％（95％CI77-99％）和100％（95％CI81-100％）；对于98％（95％CI=100％）
结论：存在可直接应用于阳性血培养以检测肠杆菌产生的ESBL和碳青霉烯酶的快速表型测定，虽然临床研究有限，它们似乎具有很高的敏感性和特异性。应进一步探索它们通过及时识别细菌耐药性来促进患者护理的潜力。
