ORIGINAL RESEARCH article
Front. Cell. Infect. Microbiol.
Sec. Clinical and Diagnostic Microbiology and Immunology
Volume 15 - 2025 | doi: 10.3389/fcimb.2025.1658070
Establishment of Sensitive Sandwich‑Type Chemiluminescence Immunoassay for Aspergillus Galactomannan Antigen
Provisionally accepted
Junpu Li1*
Yan Guo2- 1Tianjin Chest Hospital, Tianjin, China
- 2Tianjin Medical University General Hospital, Tianjin, China
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Invasive pulmonary aspergillosis (IPA) poses significant diagnostic challenges in immunocompromised patients, with galactomannan (GM) detection serving as a key biomarker. Existing Platelia™ GM enzyme-linked immunosorbent assay (ELISA) faces limitations in throughput and turnaround time. we developed a magnetic bead-based chemiluminescent enzyme immunoassay (CLEIA) for GM detection in serum/bronchoalveolar lavage fluid (BALF). Optimized CLEIA parameters enabled 30-min analysis versus 120-min for ELISA. Validation with 241 clinical specimens demonstrated robust analytical performance: diagnostic thresholds of ≥ 0.20 CLEIA Units for serum and BALF matrices (ROC-AUC 0.87, p<0.0001), analytical sensitivity of 0.50 ng/mL, and precision with ≤14.40% total CV, and no hook effect ≤200 ng/mL. Method comparison against the Platelia ELISA revealed 86.72% overall diagnostic agreement (Cohen's κ=0.72), while cross-reactivity analyses indicated specificity limitations exclusively with Histoplasma-positive specimens, consistent with parallel GM ELISA results. This assay enables 75% processing time reduction with uncompromised diagnostic accuracy, positioning it as a high-throughput alternative for rapid IA screening in high-risk cohorts.
Keywords: Galactomannan, Immunoassay, Chemiluminescent, Serum, BALF
Received: 02 Jul 2025; Accepted: 16 Sep 2025.
Copyright: © 2025 Li and Guo. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Junpu Li, junpuli@163.com
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