The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective study

Objectives: We provide the first evaluation of the CE-IVD marked Novodiag® stool parasites assay (NVD), allowing rapid and high-plex detection of 26 distinct targets, encompassing protozoans, helminths and microsporidia in stool samples. Methods: A total of 254 samples (n = 205 patients) were prospe...

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Main Authors: Hartuis Sophie, Lavergne Rose-Anne, Nourrisson Céline, Verweij Jaco, Desoubeaux Guillaume, Lussac-Sorton Florian, Lemoine Jean-Philippe, Cateau Estelle, Jeddi Fakhri, Poirier Philippe, Le Pape Patrice, Morio Florent
Format: Article
Language:English
Published: EDP Sciences 2022-01-01
Series:Parasite
Subjects:
Online Access:https://www.parasite-journal.org/articles/parasite/full_html/2022/01/parasite210153/parasite210153.html
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author Hartuis Sophie
Lavergne Rose-Anne
Nourrisson Céline
Verweij Jaco
Desoubeaux Guillaume
Lussac-Sorton Florian
Lemoine Jean-Philippe
Cateau Estelle
Jeddi Fakhri
Poirier Philippe
Le Pape Patrice
Morio Florent
author_facet Hartuis Sophie
Lavergne Rose-Anne
Nourrisson Céline
Verweij Jaco
Desoubeaux Guillaume
Lussac-Sorton Florian
Lemoine Jean-Philippe
Cateau Estelle
Jeddi Fakhri
Poirier Philippe
Le Pape Patrice
Morio Florent
author_sort Hartuis Sophie
collection DOAJ
description Objectives: We provide the first evaluation of the CE-IVD marked Novodiag® stool parasites assay (NVD), allowing rapid and high-plex detection of 26 distinct targets, encompassing protozoans, helminths and microsporidia in stool samples. Methods: A total of 254 samples (n = 205 patients) were prospectively processed by the NVD and our routine procedure (RP). Performances of the NVD were compared with RP. Samples only positive by the NVD assay were investigated by external PCR assays. Sensitivity and specificity (Se/Sp) and time from sample receipt to results were determined for each method. The NVD was also evaluated against 77 additional samples positive for a wide range of parasites. Results: Overall positivity rate was 16.9% for RP compared with 34% using the NVD assay, and 164 samples (66%) were negative by both methods. Only 30 positive samples (12%) showed full concordance between RP and NVD. Fifty-three discordant samples were sent for external investigations. Except for Giardia intestinalis and Trichuris spp., higher Se was observed for the NVD assay for Blastocystis spp. (100% vs. 63%), Dientamoeba fragilis (100% vs. 0%), Schistosoma spp. (100% vs. 17%), and Enterobius vermicularis (100% vs. 67%) but roughly similar to RP for the remaining parasites tested. False-positive results were identified for Blastocystis spp., G. intestinalis, and Trichuris spp. using the NVD assay. The NVD mostly provides a diagnosis on the day of sample receipt compared with a mean of three days with RP. Conclusions: Besides some limitations, the NVD is a new diagnostic strategy allowing rapid and high-plex detection of gastrointestinal parasites from unpreserved stools.
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spelling doaj.art-161b943ecc3b4aef8eb51a105126758c2023-12-02T08:52:37ZengEDP SciencesParasite1776-10422022-01-01292710.1051/parasite/2022026parasite210153The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective studyHartuis Sophie0Lavergne Rose-Anne1Nourrisson Céline2Verweij Jaco3Desoubeaux Guillaume4Lussac-Sorton Florian5Lemoine Jean-Philippe6Cateau Estelle7Jeddi Fakhri8Poirier Philippe9Le Pape Patrice10Morio Florent11https://orcid.org/0000-0002-5859-6105Nantes Université, CHU de Nantes, Cibles et Médicaments des Infections et de l’Immunité, IICiMed, UR1155Nantes Université, CHU de Nantes, Cibles et Médicaments des Infections et de l’Immunité, IICiMed, UR1155Laboratoire de Parasitologie–Mycologie, Centre de Biologie, CHU Gabriel MontpiedElisabeth-TweeSteden Hospital, Microvida Laboratory for Medical Microbiology and ImmunologyService de Parasitologie – Mycologie – Médecine Tropicale, CHRU de ToursLaboratoire de Parasitologie–Mycologie PTMI – Groupe Hospitalier PellegrinLaboratoire de Parasitologie–Mycologie, CHULaboratoire de Parasitologie et Mycologie Médicales, CHU La MiletrieNantes Université, CHU de Nantes, Cibles et Médicaments des Infections et de l’Immunité, IICiMed, UR1155Laboratoire de Parasitologie–Mycologie, Centre de Biologie, CHU Gabriel MontpiedNantes Université, CHU de Nantes, Cibles et Médicaments des Infections et de l’Immunité, IICiMed, UR1155Nantes Université, CHU de Nantes, Cibles et Médicaments des Infections et de l’Immunité, IICiMed, UR1155Objectives: We provide the first evaluation of the CE-IVD marked Novodiag® stool parasites assay (NVD), allowing rapid and high-plex detection of 26 distinct targets, encompassing protozoans, helminths and microsporidia in stool samples. Methods: A total of 254 samples (n = 205 patients) were prospectively processed by the NVD and our routine procedure (RP). Performances of the NVD were compared with RP. Samples only positive by the NVD assay were investigated by external PCR assays. Sensitivity and specificity (Se/Sp) and time from sample receipt to results were determined for each method. The NVD was also evaluated against 77 additional samples positive for a wide range of parasites. Results: Overall positivity rate was 16.9% for RP compared with 34% using the NVD assay, and 164 samples (66%) were negative by both methods. Only 30 positive samples (12%) showed full concordance between RP and NVD. Fifty-three discordant samples were sent for external investigations. Except for Giardia intestinalis and Trichuris spp., higher Se was observed for the NVD assay for Blastocystis spp. (100% vs. 63%), Dientamoeba fragilis (100% vs. 0%), Schistosoma spp. (100% vs. 17%), and Enterobius vermicularis (100% vs. 67%) but roughly similar to RP for the remaining parasites tested. False-positive results were identified for Blastocystis spp., G. intestinalis, and Trichuris spp. using the NVD assay. The NVD mostly provides a diagnosis on the day of sample receipt compared with a mean of three days with RP. Conclusions: Besides some limitations, the NVD is a new diagnostic strategy allowing rapid and high-plex detection of gastrointestinal parasites from unpreserved stools.https://www.parasite-journal.org/articles/parasite/full_html/2022/01/parasite210153/parasite210153.htmlstoolgastrointestinal parasitesmicroscopynovodiag® stool parasiteshigh-plex detectionprospective studycomparative evaluation
spellingShingle Hartuis Sophie
Lavergne Rose-Anne
Nourrisson Céline
Verweij Jaco
Desoubeaux Guillaume
Lussac-Sorton Florian
Lemoine Jean-Philippe
Cateau Estelle
Jeddi Fakhri
Poirier Philippe
Le Pape Patrice
Morio Florent
The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective study
Parasite
stool
gastrointestinal parasites
microscopy
novodiag® stool parasites
high-plex detection
prospective study
comparative evaluation
title The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective study
title_full The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective study
title_fullStr The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective study
title_full_unstemmed The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective study
title_short The Novodiag® Stool parasites assay, an innovative high-plex technique for fast detection of protozoa, helminths and microsporidia in stool samples: a retrospective and prospective study
title_sort novodiag r stool parasites assay an innovative high plex technique for fast detection of protozoa helminths and microsporidia in stool samples a retrospective and prospective study
topic stool
gastrointestinal parasites
microscopy
novodiag® stool parasites
high-plex detection
prospective study
comparative evaluation
url https://www.parasite-journal.org/articles/parasite/full_html/2022/01/parasite210153/parasite210153.html
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