{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T01:15:32Z","timestamp":1788225332682,"version":"build-2803163510"},"reference-count":24,"publisher":"American Society for Microbiology","issue":"2","license":[{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"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":["Microbiol Spectr"],"published-print":{"date-parts":[[2026,2,3]]},"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 an emerging fungal pathogen linked to healthcare-associated infections, necessitating rapid and accurate detection for effective infection control. This study evaluated the analytical and clinical performance of the Diasorin Simplexa\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      Direct IVD assay compared to traditional culture as the reference standard and also to two lab-developed tests (LDTs) already validated in our laboratory: one using DSQ Alert primers\/probes on the Roche Cobas 5800 and another on the DiaSorin LIAISON MDX platform. Clinical accuracy was assessed using deidentified residual axillary\/groin surveillance specimens from 20 culture-positive and 20 culture-negative patients. Analytical specificity was tested against 14 microbial species commonly found in the axilla\/groin. Analytical sensitivity was determined using ZeptoMetrix\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      strain Z485. Specimen stability was examined at various temperatures. Environmental swabbing was also conducted before and after sample handling. The Diasorin Simplexa\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      IVD assay demonstrated 100% sensitivity and 90% specificity relative to culture and showed 100% positive agreement with both LDTs and 100% negative percent agreement with the DSQ Alert LDT. The assay also achieved 100% analytical specificity, with no cross-reactivity observed, and an analytical sensitivity of 702 CFU\/mL. Specimen integrity remained stable for up to 30 days under all storage conditions. No environmental contamination was detected. The DiaSorin Simplexa\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      IVD assay demonstrated strong analytical and clinical performance while offering advantages in speed, ease of use, and flexible batch size. It may serve as a practical solution for institutions seeking timely\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      screening in support of infection prevention protocols.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>IMPORTANCE<\/jats:title>\n                    <jats:p>\n                      <jats:italic toggle=\"yes\">Candida auris<\/jats:italic>\n                      is an important yeast notable for its ability to easily colonize people as well as its drug resistance. Colonized patients who become immunocompromised may ultimately become infected with\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      , without many options for treatment. Many health care facilities mandate screening patients for colonization with this yeast to help prevent transmission. This work evaluates the recently FDA approved Diasorin Simplexa\n                      <jats:italic toggle=\"yes\">C. auris<\/jats:italic>\n                      PCR based screening assay and compares its performance to cultures, as well as two existing lab-developed assays. It is the first assay performance evaluation outside of the FDA submission.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.02336-25","type":"journal-article","created":{"date-parts":[[2026,1,9]],"date-time":"2026-01-09T14:00:56Z","timestamp":1767967256000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":1,"title":["Evaluation of a novel PCR-based assay for the detection of\n                    <i>Candida auris<\/i>\n                    colonization"],"prefix":"10.1128","volume":"14","author":[{"given":"Jesse","family":"Leonard","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, University of California, San Diego","place":["La Jolla, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alicia","family":"Amamoto","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, University of California, San Diego","place":["La Jolla, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monica","family":"Bates","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, University of California, San Diego","place":["La Jolla, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anh T.","family":"Tran","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, University of California, San Diego","place":["La Jolla, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pooja","family":"Ghatbale","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, University of California, San Diego","place":["La Jolla, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8659-9429","authenticated-orcid":true,"given":"Ahnika","family":"Kline","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, University of California, San Diego","place":["La Jolla, USA"]},{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medicine, University of California, San Diego","place":["La Jolla, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T.","family":"Pride","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Pathology, University of California, San Diego","place":["La Jolla, USA"]},{"id":[{"id":"https:\/\/ror.org\/0168r3w48","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Medicine, University of California, San Diego","place":["La Jolla, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1348-0421.2008.00083.x"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.14121"},{"key":"e_1_3_2_4_2","unstructured":"CDC. 2024. Tracking Candida auris. Available from: https:\/\/www.cdc.gov\/fungal\/candida-auris\/tracking-c-auris.html"},{"key":"e_1_3_2_5_2","unstructured":"CDC. 2023. Increasing Threat of Spread of Antimicrobial-resistant Fungus in Healthcare Facilities"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12281-023-00451-7"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/myc.13471"},{"key":"e_1_3_2_8_2","unstructured":"WHO. 2022. WHO fungal priority pathogens list to guide research development and public health action W.H. W.H. Organization Editor"},{"key":"e_1_3_2_9_2","unstructured":"Antibiotic Resistance Threats in the United States 2019. 2019. CDC: Atlanta GA U.S. Department of Health and Human Services"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1186\/s40560-018-0342-4"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00367-15"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.4014\/jmb.1609.09012"},{"key":"e_1_3_2_13_2","unstructured":"CDC. 2025. Screening for Candida auris. Available from: https:\/\/www.cdc.gov\/candida-auris\/screening\/index.html"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaf365"},{"key":"e_1_3_2_15_2","unstructured":"CDC. 2024. Guidance for detection of C. auris colonization. Available from: https:\/\/www.cdc.gov\/candida-auris\/hcp\/laboratories\/detection-colonization.html"},{"key":"e_1_3_2_16_2","unstructured":"Molecular D. 2024. Simplexa C. auris Direct package insert \u2013 A real-time PCR assay intended for the in vitro qualitative detection of Candida auris DNA"},{"key":"e_1_3_2_17_2","unstructured":"College of American Pathologists. 2024. Microbiology checklist. Available from: https:\/\/documents-cloud.cap.org"},{"key":"e_1_3_2_18_2","unstructured":"CDC. 2024. Procedure for isolation of C. auris. Available from: https:\/\/www.cdc.gov\/candida-auris\/hcp\/laboratories\/isolation-procedure.html"},{"key":"e_1_3_2_19_2","unstructured":"CDC. 2023. Identification of Candida auris. Available from: https:\/\/www.cdc.gov\/candida-auris\/hcp\/laboratories\/identification-of-c-auris.html"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1099\/jmm.0.001820"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2021.658329"},{"key":"e_1_3_2_22_2","unstructured":"CDC. 2024. Infection Control Guidance: C. auris. https:\/\/www.cdc.gov\/candida-auris\/hcp\/infection-control\/index.html."},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1017\/ash.2023.445"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofad567"},{"key":"e_1_3_2_25_2","doi-asserted-by":"publisher","DOI":"10.1097\/RNJ.0000000000000455"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02336-25","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.02336-25","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:49:31Z","timestamp":1788223771000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.02336-25"}},"subtitle":[],"editor":[{"given":"Rebecca","family":"Yee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2026,2,3]]},"references-count":24,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2,3]]}},"alternative-id":["10.1128\/spectrum.02336-25"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.02336-25","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,3]]},"assertion":[{"value":"2025-07-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-12-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-09","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e02336-25"}}