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Human mpox is caused by the Monkeypox virus, a microorganism closely related to the Variola virus, both belonging to the Orthopoxvirus genus. Mpox had been considered a rare disease until a global outbreak occurred in 2022. People infected with the virus present similar symptoms to patients suffering smallpox and other rash illnesses, hindering diagnosis. The WHO indicated that no commercial PCR or serology kits are currently widely available. In the present study, the MPXV MONODOSE dtec-qPCR kit was validated following guidelines of the UNE/EN ISO/IEC 17025:2005. The parameters evaluated for the acceptance of the assay were in silico and in vitro specificity, quantitative phase analysis, reliability, and sensitivity. The assay passed validation criteria and yielded an efficiency of 95.8%, high repeatability, reproducibility, and a Limit of Detection and Quantification of at least 10 copies. Results from the validation of the MPXV dtec-qPCR kit were satisfactory. The use of the MONODOSE format (dehydrated single PCR-tubes, ready to use) provided considerable advantages allowing the detection of the Monkeypox virus to be accurately achieved. This detection kit may be considered a reliable, fast, simple, and universally available option. [ABSTRACT FROM AUTHOR]

Summary: Candida auris is an emerging multidrug resistant pathogenic fungus that causes candidaemia with high mortality rates and exhibits the ability to persist within the hospital environment. Candida auris is phylogenetically closely related to Candida haemulonii, C. lusitaniae, C. pseudohaemulonii and C. duobushaemulonii and is frequently 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 (10‐106 standard DNA copies), reliability (repeatability/reproducibility) and sensitivity (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 laboratories by testing strain JCM15448T 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 considerable 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. [ABSTRACT FROM AUTHOR]

Candida auris is a multidrug-resistant pathogenic ascomycete yeast of increasing health concern. C. auris colonizes patient's skin and can persist for weeks on surfaces, so it can be transmitted within and between hospitals. The most common diagnostic platforms in microbiology use reference databases that have not yet incorporated C. auris, misidentifying it. This chapter describes how to detect C. auris by qPCR with the GPS™ CanAur MONODOSE dtec-qPCR Test (Alicante, Spain) in less than 45 min, using ready-to-use tubes with all the components dehydrated. This commercial kit was subjected to validation following the guidelines of the UNE-EN ISO/IEC 17025:2005 and French Standard NF T90-471:2010., (© 2022. The Author(s), under exclusive license to Springer Science+Business Media, LLC, part of Springer Nature.)

Candida auris is an emerging multidrug resistant pathogenic fungus that causes candidaemia with high mortality rates and exhibits the ability to persist within the hospital environment. Candida auris is phylogenetically closely related to Candida haemulonii, C. lusitaniae, C. pseudohaemulonii and C. duobushaemulonii and is frequently 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 sensitivity (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 laboratories 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 considerable 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., (© 2018 Blackwell Verlag GmbH.)