{Reference Type}: Journal Article
{Title}: Identification and validation of diagnostic cut-offs of the ELISpot assay for the diagnosis of invasive aspergillosis in high-risk patients.
{Author}: Bettelli F;Vallerini D;Lagreca I;Barozzi P;Riva G;Nasillo V;Paolini A;D'Amico R;Forghieri F;Morselli M;Pioli V;Gilioli A;Giusti D;Messerotti A;Bresciani P;Cuoghi A;Colaci E;Marasca R;Pagano L;Candoni A;Maertens J;Viale P;Mussini C;Manfredini R;Tagliafico E;Sarti M;Trenti T;Lewis R;Comoli P;Eccher A;Luppi M;Potenza L;
{Journal}: PLoS One
{Volume}: 19
{Issue}: 7
{Year}: 2024
{Factor}: 3.752
{DOI}: 10.1371/journal.pone.0306728
{Abstract}: <B>OBJECTIVE: </B>We investigated the performance of enzyme linked immunospot (ELISpot) assay for the diagnosis of invasive aspergillosis (IA) in high-risk patients with hematologic malignancies.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.