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SHR Neuro Cancer Cardio Lipid Metab Microb
Boyer, J; Sedik, S; Egger, M; Dichtl, K; Prattes, J; Kriegl, L; Krause, R; Prüller, F; Hoenigl, M.
Performance of the clarus Aspergillus galactomannan enzyme immunoassay prototype for the diagnosis of invasive pulmonary aspergillosis in serum.
Mycoses. 2024; 67(6): e13756
Doi: 10.1111/myc.13756
Web of Science
PubMed
FullText
FullText_MUG
- Leading authors Med Uni Graz
- Boyer Johannes
- Hönigl Martin
- Prattes Jürgen
- Co-authors Med Uni Graz
- Dichtl Karl
- Egger Matthias Florian
- Krause Robert
- Kriegl Lisa
- Prüller Florian
- Sedik Sarah
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- Abstract:
- BACKGROUND: Serum galactomannan (GM) testing is essential for diagnosing invasive aspergillosis (IA), particularly in immunocompromised individuals. The global lack of on-site GM testing capacities necessitates cost-effective alternatives, such as .the clarus Aspergillus GM enzyme immunoassay prototype (clarus AGM prototype). METHODS: This single-centre, cross-sectional study compared the diagnostic performance of the clarus AGM prototype (IMMY, Norman, Oklahoma) with the serological gold standard (=Platelia AGM assay; Bio-Rad, Marnes-la-Cocquette, France). IA was classified according to modified 2020 EORTC/MSG consensus and 2024 FUNDICU criteria. In total, 300 prospectively (May-Dec 2023) and retrospectively (2012-2015) collected samples were included. RESULTS: Among 300 samples from 232 patients, 49 (16%) were classified as proven (n = 1) or probable IA (n = 48). In non-IA cases (n = 250), one patient was classified as possible IA. With the manufacturer recommended cut-off of ≥0.2, sensitivity and specificity of the clarus AGM prototype were 27% (13/49; 95% confidence interval [CI]: 15%-41%) and 99% (248/250; 95% CI: 97%-100%), respectively, while sensitivity and specificity were 78% and 79% when using the optimised Youden's cut-off of 0.0045 ODI. ROC curve analysis demonstrated an area under the curve (AUC) of 0.829 (95% CI: 0.760-0.898) for the clarus AGM prototype in distinguishing between proven/probable IA and non-IA. The AUC for the Platelia AGM was 0.951 (95% CI: 0.909-994). Spearman's correlation analysis showed a weak correlation between the two assays (0.382; p < .001). CONCLUSIONS: The weak correlation between the clarus AGM prototype and Platelia AGM highlights the need for further investigation into the clinical performance of the clarus AGM prototype, giving the different antigen epitopes addressed.
- Find related publications in this database (using NLM MeSH Indexing)
- Humans - administration & dosage
- Mannans - blood
- Galactose - analogs & derivatives
- Invasive Pulmonary Aspergillosis - diagnosis
- Immunoenzyme Techniques - methods
- Cross-Sectional Studies - administration & dosage
- Male - administration & dosage
- Middle Aged - administration & dosage
- Female - administration & dosage
- Sensitivity and Specificity - administration & dosage
- Aged - administration & dosage
- Retrospective Studies - administration & dosage
- Aspergillus - isolation & purification, immunology
- Adult - administration & dosage
- Prospective Studies - administration & dosage
- Antigens, Fungal - blood
- Aged, 80 and over - administration & dosage
- Young Adult - administration & dosage
- ROC Curve - administration & dosage
- Find related publications in this database (Keywords)
- Aspergillus antigen
- diagnostics
- enzyme-linked immunoassay
- galactomannan
- invasive aspergillosis
- serum