Evaluation of loop-mediated isothermal amplification assay for detection of Clostridioides difficile infection: A prospective diagnostic performance study

A novel Loop-mediated isothermal amplification (LAMP) assay, HiberGene's CD was evaluated with 82 unformed stools from patients suspected of C. difficile infection (CDI). Compared to glutamate dehydrogenase (GDH) toxins A/B test (C.diff Quik Chek®), HiberGene's LAMP showed 100% of sensitiv...

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Bibliographic Details
Published in:Anaerobe 2021-10, Vol.71, p.102410-102410, Article 102410
Main Authors: Girão, Evelyne Santana, Vásconez Noguera, Saidy Liceth, Sanchez Espinoza, Evelyn Patricia, Pereira Alves Madeira Bezerra, Camila Loredana, Lino, Fernando Molina, Côrtes, Marina Farrel, Alves dos Santos, Sânia, Paranhos-Baccala, Gláucia, Perdigão Neto, Lauro Vieira, Costa, Silvia Figueiredo
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Bacterial Proteins - genetics
Bacterial Toxins - genetics
Child
Clostridioides difficile
Clostridioides difficile - genetics
Clostridioides difficile - isolation & purification
Clostridium Infections - diagnosis
Clostridium Infections - microbiology
Diagnostic Tests, Routine - methods
Feces - microbiology
Female
Glutamate Dehydrogenase - genetics
Humans
Loop-mediated isothermal amplification assay
Male
Middle Aged
Molecular Diagnostic Techniques - methods
Nucleic Acid Amplification Techniques - methods
Nucleic acid amplification test
Prospective Studies
Sensitivity and Specificity
Young Adult
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Summary:A novel Loop-mediated isothermal amplification (LAMP) assay, HiberGene's CD was evaluated with 82 unformed stools from patients suspected of C. difficile infection (CDI). Compared to glutamate dehydrogenase (GDH) toxins A/B test (C.diff Quik Chek®), HiberGene's LAMP showed 100% of sensitivity and 95,8% of specificity; and compared to FilmArray™ GI panel ® (BioFire), a sensitivity of 81,2% and a specificity of 100%, with 96.38% of agreement. [Display omitted] •Loop-mediated isothermal amplification (LAMP) is a novel nucleic acid amplification test for Clostridioides difficile diagnostic.•HiberGene’s LAMP assay for C. difficile showed 100% of sensitivity and 96 % of specificity, compared to C. diff Quik Chek.•81% of sensitivity and 100% of specificity, compared with FilmArray test.•96 % of agreement, Kappa (0.80–0.90).
ISSN:1075-9964
1095-8274
DOI:10.1016/j.anaerobe.2021.102410