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Sedik, S; Boyer, J; Egger, M; Dichtl, K; Prattes, J; Prüller, F; Hoenigl, M.
Comparative Analysis of the Clarus Aspergillus Galactomannan Enzyme Immunoassay Prototype for the Diagnosis of Invasive Pulmonary Aspergillosis in Bronchoalveolar Lavage Fluid.
Mycopathologia. 2024; 189(4):67 Doi: 10.1007/s11046-024-00876-9 [OPEN ACCESS]
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Führende Autor*innen der Med Uni Graz
Boyer Johannes
Hönigl Martin
Prattes Jürgen
Sedik Sarah
Co-Autor*innen der Med Uni Graz
Dichtl Karl
Egger Matthias Florian
Prüller Florian
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Abstract:
BACKGROUND: Galactomannan (GM) testing using Platelia Aspergillus enzyme immunoassay (Platelia AGM) from bronchoalveolar lavage fluid (BALF) aids in early diagnosis of invasive pulmonary aspergillosis (IPA). Globally, only a minority of laboratories have the capability to perform on-site GM testing, necessitating accessible and affordable alternatives. Hence, we conducted a comparative evaluation of the new clarus Aspergillus GM enzyme immunoassay prototype (clarus AGM prototype) with Platelia AGM using BALF samples. METHODS: This is a single-center, prospective, cross-sectional study, where Platelia AGM testing was routinely performed followed by clarus AGM prototype testing in those with true positive or true negative AGM test results according to the 2020 EORTC/MSG and the 2024 FUNDICU consensus definitions. Descriptive statistics, ROC curve analysis, and Spearman's correlation analysis were used to evaluate analytical performance of the clarus AGM prototype assay. RESULTS: This study enrolled 259 adult patients, of which 53 (20%) were classified as probable IPA, while 206 did not fulfill IPA-criteria. Spearman's correlation analysis revealed a strong correlation between the two assays (rho = 0.727, p < 0.001). The clarus AGM prototype had a sensitivity of 96% (51/53) and a specificity of 74% (153/206) for differentiating probable versus no IPA when using the manufacturer recommended cut-off. ROC curve analysis showed an AUC of 0.936 (95% CI 0.901-0.971) for the clarus AGM prototype, while the Platelia AGM yielded an AUC of 0.918 (95% CI 0.876-0.959). CONCLUSIONS: Clarus AGM prototype demonstrated a strong correlation and promising test performance, comparable to Platelia AGM, rendering it a viable alternative in patients at risk of IPA.
Find related publications in this database (using NLM MeSH Indexing)
Humans - administration & dosage
Mannans - analysis
Galactose - analogs & derivatives
Bronchoalveolar Lavage Fluid - microbiology, chemistry
Prospective Studies - administration & dosage
Invasive Pulmonary Aspergillosis - diagnosis
Immunoenzyme Techniques - methods
Cross-Sectional Studies - administration & dosage
Middle Aged - administration & dosage
Male - administration & dosage
Female - administration & dosage
Aspergillus - isolation & purification
Adult - administration & dosage
Sensitivity and Specificity - administration & dosage
Aged - administration & dosage
ROC Curve - administration & dosage
Young Adult - administration & dosage

Find related publications in this database (Keywords)
Invasive pulmonary aspergillosis
Galactomannan
BALF
Enzyme-linked immunoassay
Diagnostics
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