Background: Prompt diagnosis of invasive fungal infections (IFI) remains a challenge. (1,3)β-D-glucan detection in bronchoalveolar lavage (BAL) fluid by Fungitell assay aims to further improve upon the test's utility by directly applying it to specimens from the target organ.
Methods: A prospective multicenter analysis of the Fungitell assay was performed on BAL and serum samples obtained from nonselected solid-organ transplantation patients suffering from probable, proven or no IFI according to the revised criteria of the European Organisation for Research and Treatment of Cancer / Mycosis Study Group.
Results: Two hundred thirty-three BAL and 109 serum specimens from 135 patients with proven, probable, or no IFI were tested. Based on a 100 pg/mL: cutoff per test sensitivity, specificity, positive and negative predictive values were 79.2%, 38.5%, 27.6%, and 86.3% in BALs and 79.2%, 81.8%, 69.2%, and 83.1% in sera investigated.
Conclusions: The accuracy of the (1,3)β-D-glucan test is marginal so that its utility as a clinical test for early diagnosis of IFI is questionable in the lung transplant population. Although the high negative predictive value of the Fungitell assay in both, BALs and sera, may support exclusion of pulmonary IFI in solid-organ transplantation patients, the low positive predictive value limits its utility as a screening tool for early diagnosis of IFI.