Immunogenicity and clinical efficacy of anti-SARS-CoV-2 vaccination in patients with hematological malignancies: Results of a prospective cohort study of 365 patients.
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ABSTRACT:
SUBMITTER: Salvini M
PROVIDER: S-EPMC9349729 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
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Immunogenicity and clinical efficacy of anti-SARS-CoV-2 vaccination in patients with hematological malignancies: Results of a prospective cohort study of 365 patients.
Salvini Marco M Damonte Camilla C Mortara Lorenzo L Maggi Fabrizio F Bruno Antonino A Pellegrini Giacomo G Mora Barbara B Brociner Marco M Ingrassia Alessia A Mattarucchi Roberta R Bianchi Benedetta B Sirocchi Davide D Agnoli Stefania S Rumi Elisa E Merli Michele M Fossati Alessandro A Bassi Susanna S Bombelli Raffaella R Gallazzi Matteo M Borsani Oscar O Baj Andreina A Franchi Matteo M Grossi Paolo A PA Passamonti Francesco F
American journal of hematology 20220624 8
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Project description:BackgroundA rapid and reliable diagnostic test is needed to reduce mortality through early diagnosis of invasive aspergillosis (IA) in patients with hematological malignancies.ObjectiveTo evaluate the efficacy of serum and bronchoalveolar lavage (BAL) Aspergillus galactomannan lateral flow assay (GM-LFA) in IA diagnosis and determine the correlation of GM-LFA with GM enzyme immunoassay (GM-EIA) in patients with hematological malignancies.MethodsIn this prospective multicenter study, we used serum and BAL fluid samples from patients with hematological malignancies and suspected IA and performed GM-LFA and GM-EIA. According to the EORTC/MSGERC criteria, patients were grouped as proven (n = 6), probable (n = 22), possible IA (n = 55), or no IA (n = 88). The performance of serum GM-LFA at 0.5 optical density index (ODI) and area under the curve (AUC) were calculated. Spearman's correlation analysis and kappa statistics were performed to determine the agreement between the tests.ResultsGM-LFA showed an AUC of 0.832 in proven/probable IA (sensitivity [SEN], specificity [SPE], negative predictive value [NPV], and diagnostic accuracy were 75%, 100%, 92.6%, and 93.9%, respectively, at a 0.5 ODI) versus that in no IA. A moderate positive correlation was noted between the GM-LFA and GM-EIA scores (p = 0.01). The observed agreement between the tests at 0.5 ODI was almost perfect (p < 0.001). After excluding patients who received mold-active antifungal prophylaxis or treatment, the SEN, SPE, NPV, and diagnostic accuracy for proven/probable IA were 76.2%, 100%, 93.3%, and 94.5%, respectively.ConclusionsSerum GM-LFA demonstrated high discriminatory power and good diagnostic performance for IA in patients with hematological malignancies.
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