Serum Aspergillus Galactomannan Testing in Haematological Malignancies: An Exploratory Pilot Comparison of the Sōna LFA and VIRCLIA Monotest

Rapid, single-sample galactomannan assays are increasingly used in haematology, yet direct comparisons remain scarce. This prospective, single-centre exploratory pilot study compared the sōna Aspergillus Galactomannan Lateral Flow Assay (LFA) and the VIRCLIA® Galactomannan Monotest (GM-Monotest) in 45 adults with haematological malignancies, yielding 97 paired serum samples. Reference classification followed the 2020 European Organisation for Research and Treatment of Cancer/Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) framework, modified to incorporate GM-Monotest positivity; LFA results did not inform classification. The primary patient-level analysis compared four patients with proven or probable invasive fungal disease (IFD) and 34 with no IFD. Both assays detected the same three reference-positive patients (sensitivity, 75.0%; 95% confidence interval, 30.1–95.4%). Observed specificity was 91.2% for the LFA and 100% for the GM-Monotest; three patients with no IFD were LFA-positive/GM-Monotest-negative, and both assays were negative in one probable case. Cohen’s κ was 0.634 (patient level) and 0.754 (sample level). Excluding GM-Monotest results from the reference classification reduced sensitivity to 50.0% for both assays. These preliminary findings indicate substantial categorical agreement but do not establish diagnostic equivalence; few reference-positive patients and incorporation bias constrain interpretation, particularly for the GM-Monotest. Larger studies using independent reference standards are needed.