{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T18:30:23Z","timestamp":1784140223127,"version":"3.55.0"},"reference-count":32,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cell. Infect. Microbiol."],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Invasive pulmonary aspergillosis (IPA) poses significant diagnostic challenges in immunocompromised patients, with galactomannan (GM) detection serving as a key biomarker. Existing Platelia\u2122 GM enzyme-linked immunosorbent assay (ELISA) faces limitations in throughput and turnaround time.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We developed a magnetic bead-based chemiluminescent enzyme immunoassay (CLEIA) for GM detection in serum\/bronchoalveolar lavage fluid (BALF).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Optimized CLEIA parameters enabled 30-min analysis versus 120-min for ELISA. Validation with 241 clinical specimens demonstrated robust analytical performance: diagnostic thresholds of \u2265 0.20 CLEIA Units for serum and BALF matrices (ROC-AUC 0.87, p&amp;lt;0.0001), analytical sensitivity of 0.50 ng\/mL, and precision with \u226414.40% total CV, and no hook effect \u2264200 ng\/mL. Method comparison against the Platelia ELISA revealed 86.72% overall diagnostic agreement (Cohen\u2019s k=0.72), while cross-reactivity analyses indicated specificity limitations exclusively with <jats:italic>Histoplasma<\/jats:italic>-positive specimens, consistent with parallel GM ELISA results.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fcimb.2025.1658070","type":"journal-article","created":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T05:52:03Z","timestamp":1759297923000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Establishment of sensitive sandwich\u2212type chemiluminescence immunoassay for Aspergillus galactomannan antigen"],"prefix":"10.3389","volume":"15","author":[{"given":"Junpu","family":"Li","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Guo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,10,1]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1128\/spectrum.03910-23","article-title":"Comparative performance of the Platelia Aspergillus Antigen and Aspergillus Galactomannan antigen Virclia Monotest immunoassays in serum and lower respiratory tract specimens: a \u201creal-life\u201d experience","volume":"12","author":"Albert","year":"2024","journal-title":"Microbiol. 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