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Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System

Clostridium difficile infection is a significant health burden, and innovative solutions are needed to shorten time to diagnosis and improve infection control. We evaluated the performance of the cobas(®) Cdiff test for use on the cobas(®) Liat(®) System (cobas(®) Liat(®) Cdiff), a single-sample, on...

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Detalles Bibliográficos
Autores principales: Garg, Sachin K, Lu, Kyle, Duncan, John, Peterson, Lance R., Liesenfeld, Oliver
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Akadémiai Kiadó 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5793701/
https://www.ncbi.nlm.nih.gov/pubmed/29403660
http://dx.doi.org/10.1556/1886.2017.00034
Descripción
Sumario:Clostridium difficile infection is a significant health burden, and innovative solutions are needed to shorten time to diagnosis and improve infection control. We evaluated the performance of the cobas(®) Cdiff test for use on the cobas(®) Liat(®) System (cobas(®) Liat(®) Cdiff), a single-sample, on-demand, and automated molecular solution with a 20-min turnaround time. The limit of detection was 45–90 colony-forming units (CFUs)/swab for toxigenic strains that covered the most prevalent toxinotypes, including the hyper-virulent epidemic 027/BI/NAP1 strain. Using 442 prospectively collected clinical stool specimens, we compared the performance of the cobas® Liat® Cdiff to direct culture and to the cobas® Cdiff test on the cobas® 4800 System (cobas® 4800 Cdiff) – a medium-throughput molecular platform. The sensitivity and specificity of the cobas® Liat® Cdiff compared to direct culture were 93.1% and 95.1%, respectively, and this performance did not statistically differ from the cobas® 4800 Cdiff (P < 0.05). Direct correlation of the cobas® Liat® and cobas® 4800 Cdiff tests yielded overall percent agreement of 98.6%. The test performance, automation, and turnaround time of the cobas® Liat® Cdiff enable its use for on-demand and out-of-hours testing as a complement to existing batch testing solutions like the cobas® 4800 Cdiff.