{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T18:55:40Z","timestamp":1790016940553,"version":"4.0.1"},"reference-count":29,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T00:00:00Z","timestamp":1775520000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T00:00:00Z","timestamp":1775520000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"National High Level Hospital Clinical Research Funding","award":["2022-PUMCH-C-052"],"award-info":[{"award-number":["2022-PUMCH-C-052"]}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2026,4,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      This study evaluated the diagnostic performance of a chemiluminescence immunoassay (CLIA) for detecting the\n                      <jats:italic toggle=\"yes\">Cryptococcus<\/jats:italic>\n                      glucuronoxylomannan (GXM) antigen and assessed its agreement with the U.S. Food and Drug Administration (FDA)-approved IMMY lateral flow assay (LFA). From June 2021 to September 2023, a total of 651 specimens (633 cerebrospinal fluid, 18 serum) collected from 208 cryptococcosis and 415 non-cryptococcosis patients (based on diagnostic criteria for cryptococcosis) were analyzed by Dynamiker GXM antigen-CLIA platform and IMMY GXM antigen-LFA platform. Among 623 participants, the CLIA method demonstrated a total percentage agreement (TPA) of 99.52% relative to LFA. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for CLIA were 99.04, 100, 100, and 99.52%, respectively. Serial monitoring in patients receiving antifungal therapy showed a progressive decline in GXM antigen concentrations over time. The CLIA-based GXM assay exhibited high sensitivity and specificity for the diagnosing of cryptococcosis and showed close alignment with the FDA-approved LFA. It enables tracking antigen concentration changes during treatment, providing preliminary reference for therapeutic monitoring.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>This study demonstrates that the novel chemiluminescence immunoassay (CLIA) and the conventionally used LFA have a comparable performance in the detection of glucuronoxylomannan in cerebrospinal fluid (CSF) among patients with cryptococcosis. It enables tracking antigen concentration changes during treatment, providing preliminary reference for therapeutic monitoring.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.03545-25","type":"journal-article","created":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T13:02:17Z","timestamp":1773147737000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of the performance of a novel chemiluminescence immunoassay for cryptococcal antigen detection"],"prefix":"10.1128","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7093-1121","authenticated-orcid":true,"given":"Ying","family":"Zhao","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/04jztag35","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Laboratory Medicine, State Key Laboratory of Complex, Severe, and Rare Diseases, Peking Union Medical College Hospital, Chinese 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