Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial.
Evaluation of the FilmArray Blood Culture Identification Panel: Results of a Multicenter Controlled Trial.
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DOI：
10.1128/jcm.01679-15
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发表时间：
2016-03
影响因子：
9.4
通讯作者：
Kanack KJ
中科院分区：
文献类型：
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作者：
Salimnia H;Fairfax MR;Lephart PR;Schreckenberger P;DesJarlais SM;Johnson JK;Robinson G;Carroll KC;Greer A;Morgan M;Chan R;Loeffelholz M;Valencia-Shelton F;Jenkins S;Schuetz AN;Daly JA;Barney T;Hemmert A;Kanack KJ
败血症是发病率、死亡率和医疗费用增加的主要原因。快速诊断可改善结果并降低成本。FilmArray血培养鉴定试剂盒（BioFire Diagnostics LLC，湖城UT）是一种高度多重PCR检测试剂，可从阳性血培养瓶中鉴定出24种败血症病原体（8种革兰氏阳性菌、11种革兰氏阴性菌和5种酵母菌）和3种抗菌素耐药基因（mecA、vanA/B和blaKPC）。它在约1小时内提供结果，其中2分钟用于测定设置。我们提出了一个八中心试验的结果，比较了该小组的灵敏度和特异性与实验室的标准表型鉴定技术，以及与用于区分鲍曼不动杆菌从其他成员的A。醋酸钙A.鲍曼不动杆菌复合物和检测抗菌药物耐药基因。检测包括2，207份阳性需氧血培养样本，1，568份临床样本和639份接种样本。在自动血液培养系统将培养瓶标记为阳性后8小时内，对新鲜样本进行检测或冷冻样本进行后续检测。在1，382份（88.1%）阳性临床标本中，该试剂盒至少检出一种微生物。其他样本主要含有测试条外微生物。检测组报告81份（5.86%）阳性临床标本中存在多种微生物。所有靶标检测的未分辨血培养鉴定灵敏度均超过96%，但产酸克雷伯菌（92.2%）除外，其在解决不可避免的表型错误后灵敏度达到98.3%。vanA/B和blaKPC的敏感性和特异性均为100%，mecA的敏感性和特异性分别为98.4%和98.3%。
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.