%0 Journal Article
%T Identification and validation of diagnostic cut-offs of the ELISpot assay for the diagnosis of invasive aspergillosis in high-risk patients.
%A Bettelli F
%A Vallerini D
%A Lagreca I
%A Barozzi P
%A Riva G
%A Nasillo V
%A Paolini A
%A D'Amico R
%A Forghieri F
%A Morselli M
%A Pioli V
%A Gilioli A
%A Giusti D
%A Messerotti A
%A Bresciani P
%A Cuoghi A
%A Colaci E
%A Marasca R
%A Pagano L
%A Candoni A
%A Maertens J
%A Viale P
%A Mussini C
%A Manfredini R
%A Tagliafico E
%A Sarti M
%A Trenti T
%A Lewis R
%A Comoli P
%A Eccher A
%A Luppi M
%A Potenza L
%J PLoS One
%V 19
%N 7
%D 2024
%M 38980880
%F 3.752
%R 10.1371/journal.pone.0306728
%X OBJECTIVE: We investigated the performance of enzyme linked immunospot (ELISpot) assay for the diagnosis of invasive aspergillosis (IA) in high-risk patients with hematologic malignancies.
METHODS: We prospectively enrolled two cohorts of patients undergoing intensive myelosuppressive or immunosuppressive treatments at high risk for IA. ELISpot was performed to detect Aspergillus-specific T cells producing Interleukin-10.
RESULTS: In the discovery cohort, a derived cut-off of 40 spot forming cells (SFCs)/106 PBMCs has shown to correctly classify IA cases with a sensitivity and specificity of 89.5% and 88.6%, respectively. This cut-off is lowered to 25 SFC when considering the subset of possible IA patients, with sensitivity and specificity of 76% and 93%, respectively. The application of the 40 SFCs cut-off to the validation cohort resulted in a positivity rate of 83.3% in proven/probable cases and a negativity rate of 92.5% in possible/non-IA cases. Adopting the 25 SCFs cut-off, the assay resulted positive in 83.3% of proven/probable cases while it resulted negative in 66.7% of possible/non-IA cases.
CONCLUSIONS: ELISpot shows promises in the diagnosis of IA and the possibility to use two distinct cut-offs with similar diagnostic performances according to patients' different pre-test probability of infection can widen its use in patients at risk.