Bronchoalveolar lavage (BAL) culture is a standard, though time-consuming, approach for identifying microorganisms in patients with severe lower respiratory tract (LRT) infections. The sensitivity of BAL culture is relatively low, and prior antimicrobial therapy decreases the sensitivity further, leading to overuse of empirical antibiotics. The Unyvero LRT BAL Application (Curetis GmbH, Germany) is a multiplex molecular panel that detects 19 bacteria, 10 antibiotic resistance markers, and a fungus, Pneumocystis jirovecii, in BAL fluid in ∼4.5 h. Its performance was evaluated using 1,016 prospectively collected and 392 archived specimens from 11 clinical trial sites in the United States. Overall positive and negative percent agreements with culture results for identification of bacteria that grow in routine cultures were 93.4% and 98.3%, respectively, with additional potential pathogens identified by Unyvero in 21.7% of prospectively collected specimens. For detection of P. jirovecii, the positive percent agreement with standard testing was 87.5%. Antibiotic resistance marker results were compared to standard antibiotic susceptibility test results to determine positive predictive values (PPVs). PPVs ranged from 80 to 100%, based on the microorganism and specific resistance marker(s). The Unyvero LRT BAL Application provides accurate detection of common agents of bacterial pneumonia and of P. jirovecii. The sensitivity and rapidity of this panel suggest significant clinical value for choosing appropriate antibiotics and for antibiotic stewardship.

中文翻译：

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用于检测支气管肺泡灌洗液的 Unyvero 平台的多中心评估

支气管肺泡灌洗 (BAL) 培养是一种标准的但耗时的方法，用于识别严重下呼​​吸道 (LRT) 感染患者的微生物。BAL 培养的敏感性相对较低，之前的抗菌治疗进一步降低了敏感性，导致过度使用经验性抗生素。Unyvero LRT BAL 应用程序（Curetis GmbH，德国）是一个多重分子面板，可检测 19 种细菌、10 种抗生素抗性标记物和一种真菌Pneumocystis jirovecii，在 BAL 液中约 4.5 小时。使用来自美国 11 个临床试验地点的 1,016 个前瞻性收集和 392 个存档标本评估其性能。对于在常规培养中生长的细菌的鉴定，与培养结果的总体阳性和阴性百分比分别为 93.4% 和 98.3%，Unyvero 在 21.7% 的前瞻性收集标本中发现了额外的潜在病原体。用于检测P. jirovecii，与标准测试的阳性百分比一致为 87.5%。将抗生素耐药性标记结果与标准抗生素敏感性测试结果进行比较以确定阳性预测值 (PPV)。PPV 的范围从 80% 到 100%，取决于微生物和特定的抗性标记。Unyvero LRT BAL 应用程序可准确检测常见的细菌性肺炎和P. jirovecii 病原体。该小组的敏感性和快速性表明，对于选择合适的抗生素和抗生素管理具有重要的临床价值。