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 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.