Mycoses. 2018;61:877–884. wileyonlinelibrary.com/journal/myc | 877 © 2018 Blackwell Verlag GmbH 1 | INTRODUCTION The multidrug-resistant ascomycete yeast pathogen Candida auris was first described from Japan, followed by South Korea in the same year. 1,2 This new species was closely related to Candida lu- sitaniae, C. pseudohaemulonii, C. duobushaemulonii and C. haem- ulonii, known as the C. haemulonii species complex. 3,4 Currently, C. auris has been reported in >25 countries on five continents: North America, South America, Europe, Africa, and Asia. 5,6 Unlike other yeasts, they are transmitted within and between hospi- tals, posing a serous public health threat. 7 Early detection of C. auris infections may be beneficial for early initiation of appro- priate antifungal therapy and prevention of cross infections. 8-12 Nevertheless, the inability of most available commercial identifi- cation methods to quickly diagnose C. auris remains a drawback to early therapy. 13 There are currently no therapeutic guidelines, Received: 18 May 2018 | Revised: 23 July 2018 | Accepted: 23 July 2018 DOI: 10.1111/myc.12834 ORIGINAL ARTICLE Internal validation of GPS™ MONODOSE CanAur dtec-qPCR kit following the UNE/EN ISO/IEC 17025:2005 for detection of the emerging yeast Candida auris Antonio Martínez-Murcia 1,2 | Aaron Navarro 2 | Gema Bru 2 | Anuradha Chowdhary 3 | Ferry Hagen 4,5 | Jacques F. Meis 4,6 1 Department of Microbiology, University Miguel Hernández, Orihuela, Alicante, Spain 2 Genetic PCR Solutions™, Elche, Alicante, Spain 3 Department of Medical Mycology, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi, India 4 Department of Medical Microbiology and Infectious Diseases, ECMM Excellence Center, Canisius-Wilhelmina Hospital (CWZ), Nijmegen, The Netherlands 5 Department of Medical Mycology, Westerdijk Fungal Biodiversity Institute, Utrecht, The Netherlands 6 Centre of Expertise in Mycology Radboudumc/CWZ, Nijmegen, The Netherlands Correspondence: Antonio Martínez-Murcia, Genetic PCR Solutions™, CEEI – Ronda Vall d’Uxó 125, 03206-Elche (Alicante) Spain (ammurcia@geneticpcr.com). Funding information European Union Seventh Framework Programme [FP7/2007-2011], Grant/ Award Number: 311846; IVACE, Generalitat Valenciana, Grant/Award Number: IMIDTA/2018/16 Summary Candida auris is an emerging multidrug resistant pathogenic fungus that causes can- didaemia with high mortality rates and exhibits the ability to persist within the hos- pital environment. Candida auris is phylogenetically closely related to Candida haemulonii, C. lusitaniae, C. pseudohaemulonii and C. duobushaemulonii and is fre- quently misidentified by commercial identification methods. In the present study, the GPS™ MONODOSE dtec-qPCR kit (dried single-dose PCR tubes) for the detection of C. auris was validated following the guidelines of the UNE/EN ISO/IEC 17025:2005, the French Standard NF T90-471:2010 and using fast-cycling protocols. Validation terms included in vitro specificity (inclusivity/exclusivity), quantitative phase analysis (10-10 6 standard DNA copies), reliability (repeatability/reproducibility) and sensitiv- ity (detection/quantification limits). GPS™ dtec-qPCR kits passed validation with strict acceptance criteria (n ≥ 10 repetitions). In silico specificity was proven by the designer (GPS™). Experimental inclusiveness was achieved in two independent labo- ratories by testing strain JCM15448 T and 117 clinical C. auris isolates from Asia, the Middle-East Africa, Latin America and Europe. Exclusiveness was evaluated with 25 strains of closely related Candida spp. Use of the MONODOSE format provided con- siderable advantages allowing the detection of C. auris to be accurately achieved in less than an hour. The GPS™ MONODOSE dtec-qPCR kit is ready to undergo clinical evaluation. KEYWORDS Candida auris, detection, qPCR, UNE/EN ISO/IEC 17025:2005, validation