Abstract

Final culture results are often unavailable at the time of donor organ offers, despite their importance in the evaluation of donor organ quality. We hypothesized that a rapid multiplex molecular assay could improve time to results and facilitate treatment initiation in the donors prior to organ recovery. The "Rapid Detection of Airway Pathogens for Lung Transplantation" trial (NCT03933878) is a prospective observational clinical trial investigating the efficiency and accuracy of the BioFire Pneumonia Panel in the context of donor bronchoscopy. This assay tests the presence and/or quantity for 26 common airway pathogens in 2 hours. Bronchoalveolar lavagewas collected from brain dead donors at the time of lung procurement. Molecular assay results were compared to standard of care cultures. Time to result between molecular assay and standard of care was compared by Wilcoxon signed-rank test. Agreement between assays was assessed by Cohen's kappa. A total of 35 donor samples were included. From the time of sample collection to time to result, the median time was 7.01 hours [6.59-9.18] versus 57.7 hours [44.6-72.6] (p <0.001) for the molecular and standard of care assay results, respectively. Molecular assays detected bacterial pathogens in 21 cases (60%) and viruses in 2 cases (6%), versus 57% and 3% for standard of care assays, respectively. The agreement between assays for bacteria was 0.82 (p <0.001) and 0.65 (p <0.001) for viruses. Molecular detection of lower respiratory pathogens significantly reduces the time to result while maintaining agreement with standard of care clinical cultures in the context of candidate lung allografts. Such data could inform quality assessment and facilitate timely donor management prior to organ recovery.

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