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用于鉴定重症监护病房成年患者下呼吸道标本中呼吸道病原体和主要耐药决定因素的多重 PCR 肺炎检测试剂盒的性能。

Performance of a multiplex PCR pneumonia panel for the identification of respiratory pathogens and the main determinants of resistance from the lower respiratory tract specimens of adult patients in intensive care units.

机构信息

Department of Laboratory Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.

Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.

出版信息

J Microbiol Immunol Infect. 2019 Dec;52(6):920-928. doi: 10.1016/j.jmii.2019.10.009. Epub 2019 Nov 23.

Abstract

BACKGROUND

Timely diagnostic investigation to establish the microbial etiology of pneumonia is essential to ensure the administration of effective antibiotic therapy to individual patients.

METHODS

We evaluated a multiplex PCR assay panel, the FilmArray® pneumonia panel (FilmArray PP, BioFire Diagnostics), for detection of 35 respiratory pathogens and resistance determinants and compared the performance of the standard-of-care test in intensive care unit patients with lower respiratory tract infections.

RESULTS

Among the 59 endotracheal aspirates and bronchoalveolar lavage specimens obtained from 51 adult patients, FilmArray PP was effective in detecting respiratory bacterial pathogens with an overall positive percent agreement of 90% (95% confidence interval [CI], 73.5-97.9%) and negative percent agreement of 97.4% (95% CI, 96.0-98.4%). FilmArray PP semi-quantitative reporting demonstrated a concordance rate of 53.6% for the culture-positive specimens and 86.3% for the culture-negative specimens. FilmArray PP detected 16 viral targets, whereas the conventional viral isolation failed, except influenza A, which showed 100% concordance with PCR. Coinfections were detected in 42.3% of the specimens. Substantial discrepancies were observed in identifying antimicrobial resistance gene targets and in the susceptibility testing. However, FilmArray PP may still be useful at the early stage of pneumonia before culture and susceptibility test reports are available. Consequently, the results of FilmArray PP might alter the antibiotic prescription in 40.7% of the patients.

CONCLUSIONS

FilmArray PP offers a rapid and sensitive diagnostic method for lower respiratory tract infections. However, clinical correlation is advised to determine its significance in interpreting multiple pathogens and detection of genes involved in antimicrobial resistance.

摘要

背景

及时进行诊断调查以确定肺炎的微生物病因对于确保为个体患者提供有效的抗生素治疗至关重要。

方法

我们评估了一种多重 PCR 检测试剂盒,即 FilmArray® 肺炎检测试剂盒(FilmArray PP,BioFire Diagnostics),用于检测 35 种呼吸道病原体和耐药决定因素,并比较了该检测试剂盒在重症监护病房下呼吸道感染患者中的标准护理检测方法的性能。

结果

在从 51 名成年患者中获得的 59 份气管内抽吸物和支气管肺泡灌洗液标本中,FilmArray PP 有效地检测到呼吸道细菌病原体,总体阳性符合率为 90%(95%置信区间 [CI],73.5-97.9%),阴性符合率为 97.4%(95% CI,96.0-98.4%)。FilmArray PP 的半定量报告在培养阳性标本中显示出 53.6%的一致性,在培养阴性标本中显示出 86.3%的一致性。FilmArray PP 检测到 16 种病毒靶标,而常规病毒分离失败,除了甲型流感病毒,其与 PCR 检测结果完全一致。42.3%的标本中检测到混合感染。在识别抗菌药物耐药基因靶标和药敏试验方面存在显著差异。然而,在培养和药敏试验报告可用之前,FilmArray PP 可能仍可用于肺炎的早期阶段,从而改变 40.7%患者的抗生素处方。

结论

FilmArray PP 为下呼吸道感染提供了一种快速而敏感的诊断方法。然而,建议进行临床相关性研究以确定其在解释多种病原体和检测抗菌药物耐药相关基因方面的意义。

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