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Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial

机译:FilmArray血液培养物鉴定小组的评估:多中心对照试验的结果

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Sepsis is a major cause of morbidity, mortality, and increased medical expense. Rapid diagnosis improves outcomes and reduces costs. The FilmArray blood culture identification panel (BioFire Diagnostics LLC, Salt Lake City, UT), a highly multiplexed PCR assay, can identify 24 etiologic agents of sepsis (8 Gram-positive, 11 Gram-negative, and 5 yeast species) and three antimicrobial resistance genes (mecA, vanA/B, and blaKPC) from positive blood culture bottles. It provides results in about 1 h with 2 min for assay setup. We present the results of an eight-center trial comparing the sensitivity and specificity of the panel with those of the laboratories' standard phenotypic identification techniques, as well as with molecular methods used to distinguish Acinetobacter baumannii from other members of the A. calcoaceticus-A. baumannii complex and to detect antimicrobial resistance genes. Testing included 2,207 positive aerobic blood culture samples, 1,568 clinical and 639 seeded. Samples were tested fresh or were frozen for later testing within 8 h after the bottles were flagged as positive by an automated blood culture system. At least one organism was detected by the panel in 1,382 (88.1%) of the positive clinical specimens. The others contained primarily off-panel organisms. The panel reported multiple organisms in 81 (5.86%) positive clinical specimens. The unresolved blood culture identification sensitivity for all target detections exceeded 96%, except for Klebsiella oxytoca (92.2%), which achieved 98.3% sensitivity after resolution of an unavoidable phenotypic error. The sensitivity and specificity for vanA/B and blaKPC were 100%; those for mecA were 98.4 and 98.3%, respectively.
机译:败血症是发病率,死亡率和增加医疗费用的主要原因。快速诊断可改善结果并降低成本。 FilmArray血液培养物鉴定小组(BioFire Diagnostics LLC,盐湖城,犹他州)是一种高度多重的PCR检测方法,可鉴定出败血症的24种病原体(8种革兰氏阳性,11种革兰氏阴性和5种酵母菌)和3种抗菌素阳性抗性基因( mecA vanA / B bla KPC )血液培养瓶。它可在约1小时内提供2分钟的结果以用于测定设置。我们提供了一个八中心试验的结果,该试验将专家组的敏感性和特异性与实验室标准表型鉴定技术的敏感性和特异性进行了比较,以及用于区分鲍曼不动杆菌和钙拟乙酰乙酸杆菌-A其他成员的分子方法。并能检测鲍曼不动杆菌的耐药基因。测试包括2207份阳性有氧血培养样本,1568份临床样本和639份种子。在自动自动血液培养系统将瓶子标记为阳性后的8小时内,将样品新鲜测试或冷冻以供以后测试。专家组在1,382(88.1%)阳性临床标本中检测到至少一种生物。其他主要包含非面板生物。该小组报告了81例(5.86%)阳性临床标本中的多种生物。对于所有目标检测,未解决的血培养鉴定灵敏度均超过96%,除了产酸克雷伯菌(92.2%),后者在解决了不可避免的表型错误后达到了98.3%的灵敏度。 vanA / B bla KPC 的敏感性和特异性为100%; mecA 的分别为98.4%和98.3%。

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