Department of Medicine, University of California, San Francisco, CA, USA.
Department of Surgery, University of California, San Francisco, CA, USA.
Transpl Infect Dis. 2021 Aug;23(4):e13579. doi: 10.1111/tid.13579. Epub 2021 Feb 18.
Airway infections are difficult to distinguish from acute rejection in lung transplant recipients. Traditional culture techniques take time that may delay treatment. We hypothesized that a rapid multiplex molecular assay could improve time to diagnosis and appropriate clinical decision making.
In a prospective observational study of recipients undergoing bronchoscopy, we assessed the BioFire FilmArray Pneumonia Panel (BFPP) in parallel to standard of care (SOC) diagnostics. Research clinicians performed shadow (research only) clinical decision making in real time. Time to report and interpretation were reported as median and interquartile ranges and compared by Wilcoxon signed-ranked test. Agreement was defined based on detection of any species targeted in the molecular assay.
For the 150 enrolled subjects, BFPP results were available 3.8 hours (IQR 2.8-5.1) following bronchoscopy, compared to 13 hours for viral SOC (IQR 10-34, P < .001) results and 48 hours for bacterial SOC (IQR 46-70, P < .001) results. Positive BFPP results were interpreted in 9 hours (IQR 5-20) following bronchoscopy, compared to 74 hours for SOC (IQR 37-110, P < .001). Assays agreed for 138 (92%) of the 150 subjects. Of 22 BFPP diagnoses, five (23%) resulted in a shadow antibiotic recommendation. Notable BFPP deficiencies included fungal species and H parainfluenzae, accounting for 15 (27%) and 13 (23%) of the 56 actionable SOC results, respectively.
This molecular diagnostic including bacterial targets has the potential to shorten time to diagnosis and augment current clinical decision making but cannot replace SOC culture methods.
对于肺移植受者,气道感染与急性排斥反应难以区分。传统的培养技术耗时,可能会延误治疗。我们假设快速多重分子检测可以提高诊断速度并有助于临床做出恰当的决策。
在一项前瞻性观察性研究中,我们对接受支气管镜检查的受者评估了 BioFire FilmArray 肺炎Panel(BFPP),并与标准护理(SOC)诊断方法进行了平行检测。研究临床医生实时进行了影子(仅供研究)临床决策。报告和解释的时间以中位数和四分位距表示,并通过 Wilcoxon 符号秩检验进行比较。基于分子检测中靶向的任何物种的检测来定义一致性。
对于 150 名入组患者,BFPP 结果在支气管镜检查后 3.8 小时(IQR 2.8-5.1)时可用,而病毒 SOC(IQR 10-34,P<0.001)结果则需 13 小时,细菌 SOC(IQR 46-70,P<0.001)结果则需 48 小时。BFPP 阳性结果在支气管镜检查后 9 小时(IQR 5-20)进行解读,而 SOC 则需 74 小时(IQR 37-110,P<0.001)。150 名患者中有 138 名(92%)检测结果一致。在 22 个 BFPP 诊断中,有 5 个(23%)导致了影子抗生素建议。值得注意的是,BFPP 存在真菌物种和 H 副流感病毒的检测缺陷,分别占 SOC 可采取的 56 项结果中的 15 项(27%)和 13 项(23%)。
这种包含细菌靶标的分子诊断方法有可能缩短诊断时间并增强当前的临床决策,但不能替代 SOC 培养方法。