{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T15:53:22Z","timestamp":1791561202499,"version":"4.3.4"},"reference-count":16,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T00:00:00Z","timestamp":1718150400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2024,6,12]],"date-time":"2024-06-12T00:00:00Z","timestamp":1718150400000},"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":[[2024,6,12]]},"abstract":"ABSTRACT<\/jats:title>\n \n \n \n Candida auris<\/jats:italic>\n is a multidrug-resistant opportunistic fungal pathogen capable of causing serious infections and healthcare-associated outbreaks. Screening for colonization with\n C. auris<\/jats:italic>\n has become routine and is recommended in many hospitals and healthcare facilities as an infection control and prevention strategy. Subsequently, and since there are currently no FDA-approved tests for this purpose, clinical microbiology laboratories have become responsible for developing protocols to detect\n C. auris<\/jats:italic>\n using axial and inguinal screening swabs. In a College of American Pathologists-accredited large academic healthcare center setting, we implemented a laboratory-developed nucleic-acid amplification test for the detection of\n C. auris<\/jats:italic>\n DNA. Our test validation evaluated the performance of the DiaSorin\n C. auris<\/jats:italic>\n primer set used in a real-time qualitative PCR assay on the LIAISON MDX thermocycler with the Simplexa Universal Disc. The assay was highly sensitive and specific, with a limit of detection of 1\u20132 CFU\/reaction, with no observed cross-reactivity with other\n Candida<\/jats:italic>\n spp., bacterial skin commensal organisms or commonly encountered viruses. When run in parallel with a culture-based detection method, the PCR assay was 100% sensitive and specific. The assay was precise, with low variability between replicates within and between runs. Lastly, pre-analytical factors, including swab storage time, temperature, and transport media, were assessed and found to have no significant effect on the detection of\n C. auris<\/jats:italic>\n at variable concentrations. Taken together, this study expands the available options for nucleic acid detection of\n C. auris<\/jats:italic>\n and characterizes pre-analytical factors for implementation in both high- and low-volume laboratory settings.\n <\/jats:p>\n <\/jats:sec>\n \n \n IMPORTANCE\n \n <\/jats:title>\n \n This study overviews the validation and implementation of a molecular screening tool for the detection of\n Candida auris<\/jats:italic>\n in a College of American Pathologist-accredited clinical laboratory. This molecular laboratory-developed test is both highly sensitive and specific and has significant health-system cost-savings associated with significantly reduced turn-around-time compared to traditional standard-of-care culture-based work up. This method and workflow is of interest to support clinical microbiology diagnostics and to help aid in hospital inpatient, and infection prevention control screening.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1128\/jcm.00158-24","type":"journal-article","created":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T09:01:49Z","timestamp":1714554109000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":19,"title":["Validation of a qualitative real-time PCR assay for the detection of\n Candida auris<\/i>\n in hospital inpatient screening"],"prefix":"10.1128","volume":"62","author":[{"given":"Lauren C.","family":"Franco","sequence":"first","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmoud","family":"Ahmed","sequence":"additional","affiliation":[{"name":"Division of Clinical Microbiology, Indiana University Health, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher G.","family":"Kendra","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. Matthew","family":"Sperling","sequence":"additional","affiliation":[{"name":"Division of Clinical Microbiology, Indiana University Health, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayla","family":"Van Benten","sequence":"additional","affiliation":[{"name":"Division of Clinical Microbiology, Indiana University Health, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John-Paul","family":"Lavik","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA"},{"name":"Division of Clinical Microbiology, Indiana University Health, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher L.","family":"Emery","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA"},{"name":"Division of Clinical Microbiology, Indiana University Health, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5889-1190","authenticated-orcid":true,"given":"Ryan F.","family":"Relich","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA"},{"name":"Division of Clinical Microbiology, Indiana University Health, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8358-5611","authenticated-orcid":false,"given":"Kenneth","family":"Gavina","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA"},{"name":"Division of Clinical Microbiology, Indiana University Health, Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_1_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1348-0421.2008.00083.x"},{"key":"e_1_3_1_3_2","doi-asserted-by":"publisher","DOI":"10.7326\/M22-3469"},{"key":"e_1_3_1_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00921-17"},{"key":"e_1_3_1_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhin.2017.11.015"},{"key":"e_1_3_1_6_2","doi-asserted-by":"publisher","DOI":"10.3201\/eid2302.161320"},{"key":"e_1_3_1_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/mmy\/myaa049"},{"key":"e_1_3_1_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.03220-20"},{"key":"e_1_3_1_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2020.115168"},{"key":"e_1_3_1_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01223-17"},{"key":"e_1_3_1_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00630-19"},{"key":"e_1_3_1_12_2","doi-asserted-by":"publisher","DOI":"10.3390\/jof7020154"},{"key":"e_1_3_1_13_2","unstructured":"Centers for Disease Control and Prevention. 2022. Guidance for detection of colonization of Candida auris. Available from: https:\/\/www.cdc.gov\/fungal\/candida-auris\/c-auris-guidance.html"},{"key":"e_1_3_1_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01337-18"},{"key":"e_1_3_1_15_2","doi-asserted-by":"publisher","DOI":"10.3390\/jof9080849"},{"key":"e_1_3_1_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00367-15"},{"key":"e_1_3_1_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.02202-16"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00158-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.00158-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,16]],"date-time":"2024-07-16T09:06:39Z","timestamp":1721120799000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.00158-24"}},"subtitle":[],"editor":[{"given":"Kimberly E.","family":"Hanson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,6,12]]},"references-count":16,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2024,6,12]]}},"alternative-id":["10.1128\/jcm.00158-24"],"URL":"https:\/\/doi.org\/10.1128\/jcm.00158-24","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,12]]},"assertion":[{"value":"2024-01-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-01","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00158-24"}}