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Assessment of the first commercial multiplex PCR kit (ParaGENIE Crypto-Micro Real-Time PCR) for the detection of Cryptosporidium spp., Enterocytozoon bieneusi, and Encephalitozoon intestinalis from fecal samples

Florent Morio 1, * Philippe Poirier 2 Yohann Le Govic 3 Adrien Laude 1 Stephane Valot 4 Guillaume Desoubeaux 5 Nicolas Argy 6 Céline Nourrisson 2 Christelle Pomares 7 Marie Machouart 8 Frédéric Dalle 9, 4 Françoise Botterel 10 Nathalie Bourgeois 11 Estelle Cateau 12 Marion Leterrier 13 Jessica Beser 14 Rose-Anne Lavergne 1 Patrice Le Pape 1
* Auteur correspondant
1 Laboratoire de Parasitologie-Mycologie (Institut de biologie, CHU de Nantes)
2 Laboratoire de Parasitologie-Mycologie (CHU de Clermont-Ferrand)
3 Laboratoire de Parasitologie-Mycologie (CHU d'Angers)
4 Laboratoire de parasitologie mycologie (CHU de Dijon)
5 Service de parasitologie, mycologie, médecine tropicale CHRU Bretonneau
6 Laboratoire de Parasitologie Mycologie (AP-HP, Hôpital Bichat)
7 C3M - Centre méditerranéen de médecine moléculaire
8 Service de Parasitologie-Mycologie [CHRU Nancy]
9 VAlMiS - Vin Aliment Microbiologie et Stress
PAM - Procédés Alimentaires et Microbiologiques, PAM - Procédés Alimentaires et Microbiologiques [Dijon]
10 Laboratoire de Parasitologie-Mycologie (AP-HP Hôpital Henri Mondor)
11 Laboratoire de Parasitologie-Mycologie (CHU de Montpellier)
12 Laboratoire de Parasitologie-Mycologie (CHU de Poitiers)
13 Laboratoire de Microbiologie (CHD de la Roche-Sur-Yon)
14 Public Health Agency of Sweden
Abstract : Cryptosporidium spp. Enterocytozoon bieneusi and Encephalitozoon intestinalis are opportunistic pathogens responsible for gastrointestinal diseases. We evaluated the ParaGENIE Crypto-Micro Real-Time PCR kit (Ademtech, France), the first CE-IVD compliant PCR assay available for these pathogens. This study was conducted blindly against a reference panel of 115 stool specimens including positive samples for Cryptosporidium spp. (n = 48) and E. bieneusi (n = 38) as well as negative or positive samples for other parasites to test for cross-reactivity. An additional set of samples corresponding to 8 rare Cryptosporidium species was also included. Discrepancies were evaluated with external in-house PCR tests. The ParaGENIE Crypto-Micro PCR assay displayed a sensitivity/specificity of 91.7%/100% and 97.3%/98.7% for Cryptosporidium spp. and E. bieneusi, respectively, and was able to detect all 12 Cryptosporidium species of the reference panel, including rare species. This new CE-IVD assay will facilitate the diagnosis of intestinal cryptosporidiosis and microsporidiosis, a major concern in immunocompromised patients and travelers.
Keywords : Cryptosporidium spp. CE-IVD Encephalitozoon intestinalis Stool Multiplex PCR Enterocytozoon bieneusi
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https://hal-univ-bourgogne.archives-ouvertes.fr/hal-02173550
Contributeur : Pam - Université de Bourgogne <>
Soumis le : jeudi 4 juillet 2019 - 15:12:39
Dernière modification le : mardi 22 juin 2021 - 18:06:01

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UNIV-BOURGOGNE | UNAM | PAM | UNICE | UNIV-COTEDAZUR

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Florent Morio, Philippe Poirier, Yohann Le Govic, Adrien Laude, Stephane Valot, et al.. Assessment of the first commercial multiplex PCR kit (ParaGENIE Crypto-Micro Real-Time PCR) for the detection of Cryptosporidium spp., Enterocytozoon bieneusi, and Encephalitozoon intestinalis from fecal samples. Diagnostic Microbiology and Infectious Disease, Elsevier, 2019, 95 (1), pp.34-37. ⟨10.1016/j.diagmicrobio.2019.04.004⟩. ⟨hal-02173550⟩

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