%0 Journal Article
%T Quantification of 1,3-β-d-glucan by Wako β-glucan assay for rapid exclusion of invasive fungal infections in critical patients: A diagnostic test accuracy study.
%A Cento V
%A Alteri C
%A Mancini V
%A Gatti M
%A Lepera V
%A Mazza E
%A Moioli MC
%A Merli M
%A Colombo J
%A Orcese CA
%A Bielli A
%A Torri S
%A Gasparini LE
%A Vismara C
%A De Gasperi A
%A Brioschi P
%A Puoti M
%A Cairoli R
%A Lombardi G
%A Perno CF
%J Mycoses
%V 63
%N 12
%D Dec 2020
%M 32810888
%F 4.931
%R 10.1111/myc.13170
%X <B>OBJECTIVE: </B>Rapid and reliable exclusion of invasive fungal infections (IFI) by markers able to avoid unnecessary empirical antifungal treatment is still a critical unmet clinical need. We investigated the diagnostic performance of a newly available β-d-Glucan (BDG) quantification assay, focusing on the optimisation of the BDG cut-off values for IFI exclusion.<BR><B>METHODS: </B>BDG results by Wako β-glucan assay (lower limit of detection [LLOD] = 2.16 pg/mL, positivity ≥ 11 pg/mL) on two consecutive serum samples were retrospectively analysed in 170 patients, admitted to haematological wards (N = 42), intensive care units (ICUs; N = 80), or other wards (N = 48), exhibiting clinical signs and/or symptoms suspected for IFI. Only patients with proven IFI (EORTC/MSG criteria) were considered as true positives in the assessment of BDG sensitivity, specificity and predictive values.<BR><B>RESULTS: </B>Patients were diagnosed with no IFI (69.4%), proven IFI (25.3%) or probable IFI (5.3%). Two consecutive BDG values < LLOD performed within a median of 1 (interquartile range: 1-3) day were able to exclude a proven IFI with 100% sensitivity and negative predictive value (primary study goal). Test's specificity improved by using two distinct positivity and negativity cut-offs (7.7 pg/mL and LLOD, respectively), but remained suboptimal in ICU patients (50%), as compared to haematological or other patients (93% and 90%, respectively).<BR><B>CONCLUSIONS: </B>The classification of Wako's results as negative when < LLOD, and positive when > 7.7 pg/mL, could be a promising diagnostic approach to confidently rule out an IFI in both ICU and non-ICU patients. The poor specificity in the ICU setting remains a concern, due to the difficulty to interpret positive results in this fragile population.