{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,10]],"date-time":"2026-09-10T22:52:22Z","timestamp":1789080742203,"version":"build-2803163510"},"reference-count":44,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T00:00:00Z","timestamp":1778630400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T00:00:00Z","timestamp":1778630400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2026,5,13]]},"abstract":"ABSTRACT<\/jats:title>\n \n \n \n Invasive\n Candida<\/jats:italic>\n infection (ICI) is the most common fungal infection in critically ill patients. This study analyzed the performance of various biomarkers in sera from the CandiSep trial, a randomized, multicenter trial including 342 sepsis patients at high risk for ICI across 18 German intensive care units. ICI and candidemia were diagnosed in 48 (14.0%) and 14 (4.1%) patients, respectively. Sera collected on 2 consecutive days at sepsis onset were analyzed for \u03b2-(1\u21923)-D-glucan (BDG; Fungitell), mannan (Platelia-\n Candida<\/jats:italic>\n -Ag-Plus [Platelia-Mn] and Serion-ELISA-antigen-\n Candida<\/jats:italic>\n [Serion-Mn]), and anti-\n Candida<\/jats:italic>\n antibodies (Platelia-\n Candida<\/jats:italic>\n -Ab-Plus, Serion-ELISA-\n Candida albicans<\/jats:italic>\n -IgA\/IgM\/IgG, and Virclia-\n Candida albicans<\/jats:italic>\n -germ-tube-antibody-IgG-Monotest). Only antigen levels (BDG, Platelia-Mn, Serion-Mn), but not anti-Candida antibody levels, were significantly elevated in ICI patients. Antigen levels were unaffected by\n Candida<\/jats:italic>\n colonization, while antibody levels were significantly increased. Sensitivity and specificity at the manufacturer\u2019s cutoffs were unsatisfactory. Performance improved by adjusting cutoffs: BDG required a 3-fold increase, while all others required lowering. At 80% specificity, sensitivities (95% confidence intervals) for the diagnosis of ICI and candidemia were as follows: BDG (cutoff >280 pg\/mL), 46% (31.4\u201360.8) and 64% (35.1\u201387.2); Platelia-Mn (cutoff >50 pg\/mL), 38% (24.0\u201352.6) and 64% (35.1\u201387.2); Serion-Mn (cutoff >0.7 U\/mL), 38% (24.0\u201352.6) and 50% (23.0\u201377.0), and below 28% and 43% for all antibody assays. Area under the receiver operating characteristic curve comparisons showed no significant differences between antigen assays. Combining biomarkers, either simultaneously or sequentially, offered no diagnostic advantage over single-biomarker use. In conclusion, anti-\n Candida<\/jats:italic>\n antibody assays are likely influenced by colonization and have limited diagnostic utility. Antigen assays offer similar diagnostic value but require cutoff optimization. Combining biomarkers did not enhance diagnostic yield in our cohort.\n <\/jats:p>\n \n IMPORTANCE<\/jats:title>\n \n Our main findings based on our specific ICU cohort were as follows: (i) only\n Candida<\/jats:italic>\n antigen levels, not anti-\n Candida<\/jats:italic>\n antibody levels, were significantly elevated in ICI and candidemia. (ii) In patients without ICI, Candida colonization was not associated with altered antigen levels, but with elevated antibody levels. (iii) Sensitivity and specificity at the manufacturer\u2019s cutoffs were unsatisfactory, and cutoffs should be significantly adjusted. Potential optimal cutoff values are proposed by us. (iv) The evaluated antigen assays demonstrated overall comparable diagnostic performance in this study. (v) Anti-\n Candida<\/jats:italic>\n antibody assays did not provide a meaningful diagnostic contribution. (vi) The combination of biomarkers offered no diagnostic advantage over the use of individual biomarkers, neither simultaneously nor sequentially. Our results suggest that the use of a single\n Candida<\/jats:italic>\n antigen test with a cohort-adapted cutoff value may be sufficient. Furthermore, avoiding biomarker combinations could potentially reduce healthcare costs. The clinical implications of these findings should be interpreted with caution, given the limited data with associated large confidence intervals for candidemia and the cohort-specific nature of the study. Our results should therefore be confirmed in larger studies and additionally with other patient groups.\n <\/jats:p>\n <\/jats:sec>\n <\/jats:sec>","DOI":"10.1128\/jcm.01500-25","type":"journal-article","created":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T13:02:06Z","timestamp":1776949326000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic performance of \u03b2-(1\u21923)-D-glucan, two\n Candida<\/i>\n antigen, and five anti-\n Candida<\/i>\n antibody assays in ICU patients with sepsis and high risk for invasive candidiasis: a secondary endpoint of the CandiSep randomized clinical trial"],"prefix":"10.1128","volume":"64","author":[{"given":"Lea","family":"Standl","sequence":"first","affiliation":[{"name":"Mikrobiologisches Institut - Klinische Mikrobiologie, Immunologie und Hygiene, Universit\u00e4tsklinikum Erlangen und Friedrich-Alexander-Universit\u00e4t (FAU)","place":["Erlangen, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timo","family":"Huber","sequence":"additional","affiliation":[{"name":"Mikrobiologisches Institut - Klinische Mikrobiologie, Immunologie und Hygiene, Universit\u00e4tsklinikum Erlangen und Friedrich-Alexander-Universit\u00e4t (FAU)","place":["Erlangen, Germany"]},{"name":"Department of Anesthesiology, University Hospital Erlangen","place":["Erlangen, Germany"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank","family":"Bloos","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/035rzkx15","id-type":"ROR","asserted-by":"publisher"}],"name":"Center for Sepsis Control and Care, Jena University Hospital","place":["Jena, Germany"]},{"id":[{"id":"https:\/\/ror.org\/035rzkx15","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital","place":["Jena, 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