Evaluation of the JF5-based Aspergillus galactomannoprotein lateral flow device for diagnosing invasive aspergillosis in cancer patients

Lijuan Wan; Xueqin Cai; Meng Ling; Jinsong Kan; Meiling Yin; Huiyan Wang

doi:10.1007/s10096-024-04830-x

Evaluation of the JF5-based Aspergillus galactomannoprotein lateral flow device for diagnosing invasive aspergillosis in cancer patients

Eur J Clin Microbiol Infect Dis. 2024 Apr 16. doi: 10.1007/s10096-024-04830-x. Online ahead of print.

Authors

Lijuan Wan¹, Xueqin Cai¹, Meng Ling², Jinsong Kan¹, Meiling Yin¹, Huiyan Wang³

Affiliations

¹ Department of Laboratory Diagnostics, Division of Life Sciences and Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, Anhui, 230001, PR China.
² Department of Intensive Care Unit, Division of Life Sciences and Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, Anhui, 230001, PR China.
³ Department of Laboratory Diagnostics, Division of Life Sciences and Medicine, The First Affiliated Hospital of USTC, University of Science and Technology of China, Hefei, Anhui, 230001, PR China. wanghuiyanyx@ustc.edu.cn.

PMID: 38625450
DOI: 10.1007/s10096-024-04830-x

Abstract

Purpose: Cancer patients are at heightened risk for invasive aspergillosis (IA), a condition associated with elevated mortality risk. The JF5-based Aspergillus Galactomannoprotein Lateral Flow Device (AspLFD) offers rapid point-of-care testing (POCT) for IA. This study evaluated the diagnostic performance of AspLFD in cancer populations.

Methods: This retrospective study examined cancer patient bronchoalveolar lavage fluid (BALF) and serum samples collected between September 2021 and January 2023. Both AspLFD and galactomannan (GM) assays were conducted, and the results were analysed by two independent researchers.

Results: This study included 242 samples from 218 cancer patients, with 58 BALF and 184 serum samples. The overall agreement between AspLFD and GM assay results was 92.1%, with a kappa value of 0.552. AspLFD diagnosed proven/probable IA with a sensitivity and specificity of 91.7% and 95.3%, respectively, whereas GM exhibited sensitivity and specificity values of 83.3% and 93.7%, respectively. There were no statistical differences in the sensitivity and specificity between the two methods (P > 0.05). For serum analyses, AspLFD and GM exhibited similar sensitivity (66.7% vs. 66.7%, P > 0.05) and specificity (98.6% vs. 96.6%, P > 0.05) values. However, the sensitivity of the AspLFD was superior to the GM assay (100% vs. 88.9%) in BALF analyses but the difference was not statistically significant (P > 0.05), with no difference in specificity (83.7% vs. 83.7%, P > 0.05). In the solid-tumour cohort, both the AspLFD and GM assay exhibited high sensitivity (100% for both) and specificity (94.2% vs. 92.8%, P > 0.05).

Conclusion: The AspLFD demonstrated good performance in diagnosing IA in cancer patients, especially those with solid tumours. The AspLFD is thus an alternative POCT, particularly when GM evaluations are not readily available.

Keywords: Aspergillus; Cancer patients; Diagnostic performance; Galactomannoprotein; Invasive aspergillosis; Lateral flow device.

Grants and funding

2208085MH253/Natural Science Foundation of Anhui Province, People's Republic of China.