Performance Comparison of a Novel Rapid Stand-alone Molecular Test and a 2-Step Diagnostic Algorithm for Clostridioides difficile Detection in Children.
Pediatr Infect Dis J
; 40(2): 169-172, 2021 02 01.
Article
em En
| MEDLINE
| ID: mdl-33055503
ABSTRACT
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 2-18 years of age 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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Reação em Cadeia da Polimerase
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Clostridioides difficile
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Técnicas Imunoenzimáticas
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Infecções por Clostridium
Tipo de estudo:
Diagnostic_studies
/
Prognostic_studies
Limite:
Child
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Child, preschool
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Female
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Humans
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Male
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article