{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T14:52:32Z","timestamp":1791384752728,"version":"4.3.3"},"reference-count":39,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T00:00:00Z","timestamp":1791331200000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Pearl Diagnostics, Inc."},{"DOI":"10.13039\/501100012264","name":"NIH)","doi-asserted-by":"publisher","award":["R44AI157572"],"award-info":[{"award-number":["R44AI157572"]}],"id":[{"id":"10.13039\/501100012264","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Invasive aspergillosis (IA) is difficult to diagnose, contributing to poor clinical outcomes and unnecessary antifungal therapies. The MycoMEIA Aspergillus assay (MycoMEIA), which detects Aspergillus glycans in urine, does not require invasive specimens. We report data that supported regulatory approval.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A case-control study and prospective cohort study were conducted to evaluate MycoMEIA as an aid to diagnose IA. Performance was assessed using consensus criteria of \u201cproven\u201d or \u201cprobable\u201d IA and controls. Additional analyses evaluated positivity in \u201cpossible\u201d IA, agreement with serum galactomannan (GM EIA), cross-reactivity, and timing of positivity relative to clinical diagnosis. Reproducibility was assessed across three laboratories.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In brief, 469 urine samples from 50 IA cases and 240 controls demonstrated MycoMEIA 92% (95% CI 80.8\u201397.8) sensitivity and 87.6% (95% CI 82.8\u201391.8) specificity. All cases with positive serum GM EIA were positive by MycoMEIA. Urine testing identified 19\/24 (79.2%) IA cases diagnosed by bronchoalveolar lavage (BAL) but negative by serum GM EIA and provided lead-time positivity of 5 days (range \u221221 to +14) before clinical diagnosis. Prospective testing confirmed a specificity of 89.7% (95% CI 75.8\u201397.1) and identified IA in 28\/102 (27.5%) people with suspected \u201cpossible\u201d IA. Some cross-reactivity was observed with other Ascomycetes fungi. Results were reproducible across sites.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>MycoMEIA shows strong performance as an aid to diagnose IA. Its high sensitivity and negative predictive value may help reduce unnecessary empirical antifungals. Further studies are needed to define its role in screening and broader patient populations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag522","type":"journal-article","created":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T11:39:15Z","timestamp":1788521955000},"source":"Crossref","is-referenced-by-count":0,"title":["Performance of the Urinary Myco\n                    <i>MEIA Aspergillus<\/i>\n                    Assay as an Aid to Diagnose Invasive Aspergillosis"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-7845-2721","authenticated-orcid":false,"given":"Irina","family":"Baburina","sequence":"first","affiliation":[{"name":"Pearl Diagnostics , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1051-0376","authenticated-orcid":false,"given":"Kieren A","family":"Marr","sequence":"additional","affiliation":[{"name":"Pearl Diagnostics , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6169-1920","authenticated-orcid":false,"given":"Yuri","family":"Vanbiervliet","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven ,","place":["Belgium"]},{"name":"Department of Haematology, University Hospitals of Leuven, Leuven ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0749-7342","authenticated-orcid":false,"given":"Nitipong","family":"Permpalung","sequence":"additional","affiliation":[{"name":"Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiung-Yu","family":"Huang","sequence":"additional","affiliation":[{"name":"University of California Department of Epidemiology and Biostatistics, , San Francisco, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robina","family":"Aerts","sequence":"additional","affiliation":[{"name":"University of Antwerp Faculty of Medicine and Health Sciences, , Antwerp ,","place":["Belgium"]},{"name":"University Hospital Antwerp Department of Pulmonary Medicine, , Edegem ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia X","family":"Marques","sequence":"additional","affiliation":[{"name":"Pearl Diagnostics , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew F","family":"Shorr","sequence":"additional","affiliation":[{"name":"Washington Medical Center Division of Pulmonary and Critical Care Medicine, MedStar , Washington DC ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M Hong","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Binghua","family":"Hao","sequence":"additional","affiliation":[{"name":"Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7478-5398","authenticated-orcid":false,"given":"John R","family":"Wingard","sequence":"additional","affiliation":[{"name":"University of Florida Department of Medicine, , Gainesville, Florida ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4257-5980","authenticated-orcid":false,"given":"Johan","family":"Maertens","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven ,","place":["Belgium"]},{"name":"Department of Haematology, University Hospitals of Leuven, Leuven ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1166-2563","authenticated-orcid":false,"given":"Sean X","family":"Zhang","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine Department of Pathology, , Baltimore, MD ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,10,7]]},"reference":[{"key":"2026100710014597800_ciag522-B1","doi-asserted-by":"crossref","first-page":"e428","DOI":"10.1016\/S1473-3099(23)00692-8","article-title":"Global incidence and mortality of severe fungal disease","volume":"24","author":"Denning","year":"2024","journal-title":"Lancet Infect Dis"},{"key":"2026100710014597800_ciag522-B2","doi-asserted-by":"crossref","first-page":"864","DOI":"10.2471\/BLT.11.089441","article-title":"Global burden of chronic pulmonary aspergillosis as a sequel to pulmonary 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