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In the present study, the <jats:styled-content style=\"fixed-case\">GPS<\/jats:styled-content><jats:sup>\u2122<\/jats:sup> <jats:styled-content style=\"fixed-case\">MONODOSE<\/jats:styled-content> dtec\u2010<jats:styled-content style=\"fixed-case\">qPCR<\/jats:styled-content> kit (dried single\u2010dose <jats:styled-content style=\"fixed-case\">PCR<\/jats:styled-content> tubes) for the detection of <jats:italic>C<\/jats:italic>.\u00a0<jats:italic>auris<\/jats:italic> was validated following the guidelines of the <jats:styled-content style=\"fixed-case\">UNE<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">EN ISO<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">IEC<\/jats:styled-content> 17025:2005, the French Standard <jats:styled-content style=\"fixed-case\">NF<\/jats:styled-content> T90\u2010471:2010 and using fast\u2010cycling protocols. Validation terms included in vitro specificity (inclusivity\/exclusivity), quantitative phase analysis (10\u201010<jats:sup>6<\/jats:sup>\u00a0standard <jats:styled-content style=\"fixed-case\">DNA<\/jats:styled-content> copies), reliability (repeatability\/reproducibility) and sensitivity (detection\/quantification limits). <jats:styled-content style=\"fixed-case\">GPS<\/jats:styled-content><jats:sup>\u2122<\/jats:sup> dtec\u2010<jats:styled-content style=\"fixed-case\">qPCR<\/jats:styled-content> kits passed validation with strict acceptance criteria (n\u00a0\u2265\u00a010 repetitions). In silico specificity was proven by the designer (<jats:styled-content style=\"fixed-case\">GPS<\/jats:styled-content><jats:sup>\u2122<\/jats:sup>). Experimental inclusiveness was achieved in two independent laboratories by testing strain <jats:styled-content style=\"fixed-case\">JCM<\/jats:styled-content>15448<jats:sup>T<\/jats:sup> and 117 clinical <jats:italic>C.\u00a0auris<\/jats:italic> isolates from Asia, the Middle\u2010East Africa, Latin America and Europe. Exclusiveness was evaluated with 25 strains of closely related <jats:italic>Candida<\/jats:italic> spp. Use of the <jats:styled-content style=\"fixed-case\">MONODOSE<\/jats:styled-content> format provided considerable advantages allowing the detection of <jats:italic>C.\u00a0auris<\/jats:italic> to be accurately achieved in less than an hour. The <jats:styled-content style=\"fixed-case\">GPS<\/jats:styled-content><jats:sup>\u2122<\/jats:sup> <jats:styled-content style=\"fixed-case\">MONODOSE<\/jats:styled-content> dtec\u2010<jats:styled-content style=\"fixed-case\">qPCR<\/jats:styled-content> kit is ready to undergo clinical evaluation.<\/jats:p>","DOI":"10.1111\/myc.12834","type":"journal-article","created":{"date-parts":[[2018,7,30]],"date-time":"2018-07-30T14:44:57Z","timestamp":1532961897000},"page":"877-884","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":33,"title":["Internal validation of <scp>GPS<\/scp><sup>\u2122<\/sup><scp>MONODOSE<\/scp> CanAur dtec\u2010<scp>qPCR<\/scp> kit following the <scp>UNE<\/scp>\/<scp>EN ISO<\/scp>\/<scp>IEC<\/scp> 17025:2005 for detection of the emerging yeast <i>Candida auris<\/i>"],"prefix":"10.1111","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1550-9590","authenticated-orcid":false,"given":"Antonio","family":"Mart\u00ednez\u2010Murcia","sequence":"first","affiliation":[{"name":"Department of Microbiology University Miguel Hern\u00e1ndez  Orihuela Alicante Spain"},{"name":"Genetic PCR Solutions<sup>\u2122<\/sup>  Elche Alicante Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron","family":"Navarro","sequence":"additional","affiliation":[{"name":"Genetic PCR Solutions<sup>\u2122<\/sup>  Elche Alicante Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gema","family":"Bru","sequence":"additional","affiliation":[{"name":"Genetic PCR Solutions<sup>\u2122<\/sup>  Elche Alicante Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anuradha","family":"Chowdhary","sequence":"additional","affiliation":[{"name":"Department of Medical Mycology Vallabhbhai Patel Chest Institute University of Delhi  Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5622-1916","authenticated-orcid":false,"given":"Ferry","family":"Hagen","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology and Infectious Diseases ECMM Excellence Center Canisius\u2010Wilhelmina Hospital (CWZ)  Nijmegen The Netherlands"},{"name":"Department of Medical Mycology Westerdijk Fungal Biodiversity Institute  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques F.","family":"Meis","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology and Infectious Diseases ECMM Excellence Center Canisius\u2010Wilhelmina Hospital (CWZ)  Nijmegen The Netherlands"},{"name":"Centre of Expertise in Mycology Radboudumc\/CWZ  Nijmegen The 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