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Laboratory evaluation of the BioFire FilmArray Pneumonia plus panel compared to conventional methods for the identification of bacteria in lower respiratory tract specimens: a prospective cross-sectional study from South Africa
Diagnostic Microbiology and Infectious Disease ( IF 2.9 ) Pub Date : 2020-10-10 , DOI: 10.1016/j.diagmicrobio.2020.115236
Barend Mitton 1 , Roxanne Rule 1 , Mohamed Said 1
Affiliation  

Lower respiratory tract infections are important causes of morbidity and mortality. The global increase in antimicrobial resistance necessitates rapid diagnostic assays. The BioFire FilmArray Pneumonia plus (FAPP) panel is a Food and Drug Administration-approved multiplex polymerase chain reaction assay that detects the most important etiological agents of pneumonia and associated antibiotic resistance genes, in approximately 1 hour. This study assessed the diagnostic performance of this assay by comparing it to conventional culture methods in the analysis of 59 lower respiratory tract specimens. The sensitivity and specificity of the FAPP panel for bacterial detection were 92.0% (95% confidence interval [CI], 80.8% to 97.8%) and 93.8% (95% CI, 91.1% to 95.3%) respectively. For detecting antibiotic resistance, the positive- and negative percent agreement were 100% (95% CI, 81.5% to 100.0%) and 98.5% (95% CI, 216 96.7% to 99.4%) respectively. The FAPP panel was found to be highly accurate in evaluating tracheal aspirate specimens from hospitalized patients.



中文翻译:

与鉴定下呼吸道标本中细菌的常规方法相比,BioFire FilmArray肺炎面板的实验室评估:来自南非的一项前瞻性横断面研究

下呼吸道感染是发病和死亡的重要原因。全球抗微生物药耐药性的提高需要快速诊断分析。BioFire FilmArray肺炎(FAPP)面板是美国食品药品监督管理局(FDA)批准的多重聚合酶链反应测定法,可在大约1小时内检测出肺炎和相关抗生素耐药基因的最重要病原体。这项研究通过与59种下呼吸道标本的分析中的常规培养方法进行比较,评估了该测定法的诊断性能。FAPP面板对细菌检测的灵敏度和特异性分别为92.0%(95%置信区间[CI],80.8%至97.8%)和93.8%(95%CI,91.1%至95.3%)。为了检测抗生素耐药性,阳性和阴性百分比一致性分别为100%(95%CI,81.5%至100.0%)和98.5%(95%CI,216 96.7%至99.4%)。

更新日期:2020-10-30
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