Performance Comparison of a Novel Rapid Stand-Alone Molecular Test and a 2-Step Diagnostic Algorithm for Clostridioides difficile Detection in Children.

BACKGROUND We aimed to evaluate diagnostic performance of the cobas® Liat® Cdiff test, a novel single-step automated polymerase chain reaction (PCR) assay for rapid diagnosis of toxigenic Clostridioides difficile infection (CDI) in stool samples from children with clinical symptoms of CDI. METHODS Assessment of cobas Liat Cdiff diagnostic yield, time of analytical process and agreement of results with those of a 2-step diagnostic algorithm. The sequential algorithm combined an enzyme immunoassay (EIA) targeting antigen glutamate dehydrogenase (GDH), enterotoxin-A and cytotoxin-B, and a confirmatory PCR in EIA GDH-positive and toxin-negative samples. Fresh stool samples were collected prospectively from patients aged 2-18 years that were attended in Hospital Sant Joan de Deu (Barcelona, Spain) during December 2018-August 2019. RESULTS A total of 122 specimens were collected from 91 children (mean age, 8 years; 69.7% male). cobas Liat Cdiff identified 24 (19.7%) positive samples. EIA yielded 97 (79.5%) GDH- and toxin-negative results, 11 (9.0%) GDH- and toxin-positive results, and 14 (11.5%) GDH-positive and toxin-negative results, of which 11 (9.0%) were positive for the toxin by the confirmatory PCR. Overall, GDH- and toxin-positive samples detected by the sequential algorithm were 22 (18.0%). Comparatively, the new test reduced time of the analytical process significantly (20 vs. 35.4 minutes, P < 0.001). CONCLUSION Use of cobas Liat Cdiff showed similar detection yield compared with a 2-step diagnostic algorithm that combined an EIA and a confirmatory PCR while decreasing the time of the analytical process markedly in stool samples from children suspected of CDI.