{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T13:37:26Z","timestamp":1786541846914,"version":"build-2736575974"},"reference-count":37,"publisher":"American Society for Microbiology","issue":"8","license":[{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"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":[[2026,8,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      <jats:italic toggle=\"yes\">Candida auris<\/jats:italic>\n                      is a multidrug-resistant fungal pathogen associated with healthcare outbreaks and high mortality. Its accurate and timely identification is critical for infection prevention, yet conventional culture-based methods are limited by slow growth, morphological ambiguity, and potential misidentification. This multicenter study evaluated the performance of the Simplexa\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      Direct assay using 2,020 axilla\/groin swab specimens collected from six clinical sites compared to culture followed by matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS). Specimens were tested prospectively (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 1,930) and retrospectively (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      = 90), with demographic data spanning inpatient, intensive care unit, emergency department, and long-term acute care hospital settings. Discordant results were resolved by bi-directional sequencing, targeting the internal transcribed spacer and D1\/D2 regions of the 28S ribosomal DNA gene. Compared to culture followed by MALDI-TOF MS identification, the Simplexa assay demonstrated an overall sensitivity of 94.8% and specificity of 98.7%, with a Cohen\u2019s kappa of 0.80, indicating strong agreement. Discordance rates were low (1.4%), and diagnostic accuracy was high (98.6%). The limit of detection was 127 CFU\/mL for Clade I and 260 CFU\/mL for Clade IV. Mean cycle threshold values were significantly lower in culture-positive specimens (25.1, 95% CI, 23.6\u201326.7) compared to culture-negative ones (33.6, 95% CI, 32.1\u201335.0;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; 0.0001). Comparative analysis with four lab-developed molecular tests (LDTs) showed low rates of discordance: 0.9% for LDT 1 and 2, 1.5% for LDT 3, and 0% for LDT 4, indicating a high level of agreement between the molecular methods. The Simplexa\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      Direct assay provides a rapid and reliable alternative to traditional methods, providing results in under 2 h, supporting early detection and containment of\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      in healthcare settings.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>\n                      Rapid and accurate detection of\n                      <jats:italic toggle=\"yes\">Candida auris<\/jats:italic>\n                      colonization is essential for preventing healthcare-associated outbreaks and reducing mortality. This multicenter evaluation demonstrates that the Simplexa\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      Direct assay offers a sensitive, specific, and practical alternative to culture-based methods, enabling earlier identification and containment of\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      . These findings provide strong evidence to support its implementation in routine infection prevention strategies across diverse healthcare settings.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.01741-25","type":"journal-article","created":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T13:01:13Z","timestamp":1782738073000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":0,"title":["Multicenter performance evaluation of the Simplexa\n                    <i>C. auris<\/i>\n                    Direct assay for the detection of\n                    <i>Candida auris<\/i>\n                    colonization in bilateral axilla\/groin swabs"],"prefix":"10.1128","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8905-5590","authenticated-orcid":false,"given":"Shadi","family":"Sepehri","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01fqg5k81","id-type":"ROR","asserted-by":"publisher"}],"name":"BayCare Health System, Inc.","place":["Clearwater, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley","family":"Schindel","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01fqg5k81","id-type":"ROR","asserted-by":"publisher"}],"name":"BayCare Health System, Inc.","place":["Clearwater, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5195-9025","authenticated-orcid":true,"given":"Suzane","family":"Silbert","sequence":"additional","affiliation":[{"name":"Tampa General Hospital","place":["Tampa, 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