Publication: Diagnostic Efficacy of Aspergillus Galactomannan Lateral Flow Assay in Patients with Hematological Malignancies: A Prospective Multicenter Study.
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Date
2023-06-05
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Abstract
Background A rapid and reliable diagnostic test is
needed to reduce mortality through early diagnosis of
invasive aspergillosis (IA) in patients with hematological malignancies.
Objective To 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.
Methods In 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. Results GM-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.
Conclusions Serum GM-LFA demonstrated high
discriminatory power and good diagnostic performance for IA in patients with hematological
malignancies.
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Keywords
Enzyme immunoassay, Galactomannan, Hematological malignancy, Invasive aspergillosis, Lateral flow assay
Citation
Alhan O., Saba R., Akalin E. H., Ener B., Ture Yuce Z., Deveci B., Guncu M. M., Kahveci H. N., Yilmaz A. F., Odabasi Z., "Diagnostic Efficacy of Aspergillus Galactomannan Lateral Flow Assay in Patients with Hematological Malignancies: A Prospective Multicenter Study.", Mycopathologia, 2023