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

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

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.

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Data availability

The data that support the findings of this study are available upon reasonable request from the corresponding author.

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Acknowledgements

The authors thank the Richardson Guangzhou Centre for Fungal Diagnostics and Research for providing the AspLFD kit for research. This centre had no role in the study design, data collection and analysis, publish decision, or manuscript preparation.

Funding

This study was supported in part by the Natural Science Foundation of Anhui Province (grant number 2208085MH253), People’s Republic of China.

Author information

Authors and 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

    Lijuan Wan, Xueqin Cai, Jinsong Kan, Meiling Yin & Huiyan Wang

  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

    Meng Ling

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  1. Lijuan Wan
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Contributions

Lijuan Wan: Conceptualization, Data Curation, Formal Analysis, Writing–Original Draft Preparation; Xueqin Cai: Data Curation, Methodology; Meng Ling: Formal Analysis, Writing–Review & Editing; Jinsong Kan: Validation; Meiling Yin: Visualization; Huiyan Wang: Conceptualization, Investigation, Writing–Review & Editing, Funding Acquisition.

Corresponding author

Correspondence to Huiyan Wang.

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Ethical approval

This study involving human participants was reviewed and approved by Institutional Ethics Committee (IEC) of the First Affiliated Hospital of USTC (code 2024-013). This study was conducted in line with the Declaration of Helsinki.

Consent to participate

Informed consent was waived by the committee because of the retrospective use of remnant and de-identified samples. Written informed consent for participation was not required for this study in accordance with the national legislation and the institutional requirements.

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Not applicable.

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The authors declare no competing interests.

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Wan, L., Cai, X., Ling, M. et al. Evaluation of the JF5-based Aspergillus galactomannoprotein lateral flow device for diagnosing invasive aspergillosis in cancer patients. Eur J Clin Microbiol Infect Dis (2024). https://doi.org/10.1007/s10096-024-04830-x

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