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

Anaerobe. 2021 Oct:71:102410. doi: 10.1016/j.anaerobe.2021.102410. Epub 2021 Jun 24.

Abstract

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.

Keywords: Clostridioides difficile; Loop-mediated isothermal amplification assay; Nucleic acid amplification test.

Publication types

  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Bacterial Proteins / genetics
  • Bacterial Toxins / genetics
  • Child
  • Clostridioides difficile / genetics*
  • Clostridioides difficile / isolation & purification
  • Clostridium Infections / diagnosis*
  • Clostridium Infections / microbiology*
  • Diagnostic Tests, Routine / methods*
  • Feces / microbiology
  • Female
  • Glutamate Dehydrogenase / genetics
  • Humans
  • Male
  • Middle Aged
  • Molecular Diagnostic Techniques / methods*
  • Nucleic Acid Amplification Techniques / methods*
  • Prospective Studies
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Bacterial Proteins
  • Bacterial Toxins
  • Glutamate Dehydrogenase

Supplementary concepts

  • LAMP assay