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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...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Akadémiai Kiadó
2017
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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 |
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author | Garg, Sachin K Lu, Kyle Duncan, John Peterson, Lance R. Liesenfeld, Oliver |
author_facet | Garg, Sachin K Lu, Kyle Duncan, John Peterson, Lance R. Liesenfeld, Oliver |
author_sort | Garg, Sachin K |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5793701 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Akadémiai Kiadó |
record_format | MEDLINE/PubMed |
spelling | pubmed-57937012018-02-05 Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System Garg, Sachin K Lu, Kyle Duncan, John Peterson, Lance R. Liesenfeld, Oliver Eur J Microbiol Immunol (Bp) Original Article 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. Akadémiai Kiadó 2017-12-05 /pmc/articles/PMC5793701/ /pubmed/29403660 http://dx.doi.org/10.1556/1886.2017.00034 Text en © 2017, The Author(s) http://creativecommons.org/licenses/by-nc/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and source are credited, a link to the CC License is provided, and changes – if any – are indicated. |
spellingShingle | Original Article Garg, Sachin K Lu, Kyle Duncan, John Peterson, Lance R. Liesenfeld, Oliver Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System |
title | Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System |
title_full | Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System |
title_fullStr | Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System |
title_full_unstemmed | Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System |
title_short | Equivalent Performance of the Cobas(®) Cdiff Test for Use on the Cobas(®) Liat(®) System and the Cobas(®) 4800 System |
title_sort | equivalent performance of the cobas(®) cdiff test for use on the cobas(®) liat(®) system and the cobas(®) 4800 system |
topic | Original Article |
url | 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 |
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