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Multicenter Study
. 2023 Oct;188(5):643-653.
doi: 10.1007/s11046-023-00749-7. Epub 2023 Jun 5.

Diagnostic Efficacy of Aspergillus Galactomannan Lateral Flow Assay in Patients with Hematological Malignancies: A Prospective Multicenter Study

Ozlem Alhan  1   2 , Rabin Saba  3 , Emin Halis Akalin  4 , Beyza Ener  5 , Zeynep Ture Yuce  6 , Burak Deveci  7 , Mehmet Mucahit Guncu  8 , Huseyin Nadir Kahveci  6 , Asu Fergun Yilmaz  9 , Zekaver Odabasi  10
Affiliations
Multicenter Study

Diagnostic Efficacy of Aspergillus Galactomannan Lateral Flow Assay in Patients with Hematological Malignancies: A Prospective Multicenter Study

Ozlem Alhan et al. Mycopathologia. 2023 Oct.

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.

Keywords: Enzyme immunoassay; Galactomannan; Hematological malignancy; Invasive aspergillosis; Lateral flow assay.

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Conflict of interest statement

All authors report no conflicts of interest. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest.

Figures

Fig. 1
Fig. 1
Study flow diagram BAL: Bronchoalveolar lavage, EIA: Enzyme immunoassay, GM: Galactomannan, IA: Invasive aspergillosis, LFA: Lateral flow assay
Fig. 2
Fig. 2
Clustered box plot of serum GM-LFA and GM-EIA ODIs EIA: Enzyme immunoassay, GM: Galactomannan, IA: Invasive aspergillosis, LFA: Lateral flow assay, ODI: Optical density index
Fig. 3
Fig. 3
ROC curve of the GM-LFA when testing serum samples A. Proven/Probable IA vs. No IA in all patients, B. Proven/Probable IA vs. No IA in patients without the use of mold-active antifungals on day 0. ROC: Receiver operator characteristic, GM: Galactomannan, LFA: Lateral flow assay, IA: Invasive aspergillosis
Fig. 4
Fig. 4
Linear correlation between GM ODI values generated by the GM-LFA and GM-EIA when testing serum samples A. Overall patients, B. Proven/Probable/Possible IA, C. Proven/Probable IA GM: Galactomannan, ODI: Optical density index, LFA: Lateral flow assay, EIA: Enzyme immunoassay, IA: Invasive aspergillosis
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