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2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels
BACKGROUND: A multicenter study was performed to evaluate the accuracy of eravacycline on a MicroScan Dried Gram-negative MIC (MSDGN) Panel when compared with a frozen CLSI broth microdilution reference panel. METHODS: For efficacy, an evaluation was conducted at three sites by comparing MIC values...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810403/ http://dx.doi.org/10.1093/ofid/ofz360.1812 |
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author | Traczewski, Maria M Beasley, Denise Harrington, Amanda DesJarlais, Sharon Garner, Omai Hastey, Christine Brookman, Regina Lockett, Zabrina Chau, Jennifer Zimmer, Barbara |
author_facet | Traczewski, Maria M Beasley, Denise Harrington, Amanda DesJarlais, Sharon Garner, Omai Hastey, Christine Brookman, Regina Lockett, Zabrina Chau, Jennifer Zimmer, Barbara |
author_sort | Traczewski, Maria M |
collection | PubMed |
description | BACKGROUND: A multicenter study was performed to evaluate the accuracy of eravacycline on a MicroScan Dried Gram-negative MIC (MSDGN) Panel when compared with a frozen CLSI broth microdilution reference panel. METHODS: For efficacy, an evaluation was conducted at three sites by comparing MIC values obtained using the MSDGN to MICs using a CLSI broth microdilution reference panel. A total of 414 Enterobacteriaceae clinical isolates were tested using the turbidity and Prompt(®*) methods of inoculation. For challenge, 79 Enterobacteriaceae isolates were tested on MSDGN panels at one site. For reproducibility, a subset of 11 organisms was tested on MSDGN panels at each site. MSDGN panels were incubated at 35 ± 2°C and read on the WalkAway System, the autoSCAN-4 instrument, and read visually. Read times for the MSDGN panels were at 16–20 hours. Frozen reference panels, prepared according to CLSI/ISO methodology, were inoculated using the turbidity inoculation method. All frozen reference panels were incubated at 35 ± 2°C and read visually. Frozen reference panels were read at 16–20 hours. FDA breakpoints (µg/mL) used for interpretation of MIC results were: Enterobacteriaceae ≤ 0.5 S. Potential major and very major errors were calculated using the NS result in place of resistant (R). RESULTS: When compared with frozen reference panel results, essential and categorical agreements for isolates tested in the Efficacy and Challenge are as follows (see table). Reproducibility among the three sites were greater than 95% for all read methods for both the turbidity and Prompt inoculation methods. CONCLUSION: This multicenter study showed that eravacycline MIC results for Enterobacteriaceae obtained with the MSDGN panel correlate well with MICs obtained using frozen reference panels using FDA interpretive criteria. * PROMPT(®) is a registered trademark of 3M Company, St. Paul, MN USA. Beckman Coulter, the stylized logo and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. Xerava™ (Eravacycline) is a registered trademark of Tetraphase Pharmaceuticals, Inc. [Image: see text] DISCLOSURES: All authors: No reported disclosures. |
format | Online Article Text |
id | pubmed-6810403 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-68104032019-10-28 2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels Traczewski, Maria M Beasley, Denise Harrington, Amanda DesJarlais, Sharon Garner, Omai Hastey, Christine Brookman, Regina Lockett, Zabrina Chau, Jennifer Zimmer, Barbara Open Forum Infect Dis Abstracts BACKGROUND: A multicenter study was performed to evaluate the accuracy of eravacycline on a MicroScan Dried Gram-negative MIC (MSDGN) Panel when compared with a frozen CLSI broth microdilution reference panel. METHODS: For efficacy, an evaluation was conducted at three sites by comparing MIC values obtained using the MSDGN to MICs using a CLSI broth microdilution reference panel. A total of 414 Enterobacteriaceae clinical isolates were tested using the turbidity and Prompt(®*) methods of inoculation. For challenge, 79 Enterobacteriaceae isolates were tested on MSDGN panels at one site. For reproducibility, a subset of 11 organisms was tested on MSDGN panels at each site. MSDGN panels were incubated at 35 ± 2°C and read on the WalkAway System, the autoSCAN-4 instrument, and read visually. Read times for the MSDGN panels were at 16–20 hours. Frozen reference panels, prepared according to CLSI/ISO methodology, were inoculated using the turbidity inoculation method. All frozen reference panels were incubated at 35 ± 2°C and read visually. Frozen reference panels were read at 16–20 hours. FDA breakpoints (µg/mL) used for interpretation of MIC results were: Enterobacteriaceae ≤ 0.5 S. Potential major and very major errors were calculated using the NS result in place of resistant (R). RESULTS: When compared with frozen reference panel results, essential and categorical agreements for isolates tested in the Efficacy and Challenge are as follows (see table). Reproducibility among the three sites were greater than 95% for all read methods for both the turbidity and Prompt inoculation methods. CONCLUSION: This multicenter study showed that eravacycline MIC results for Enterobacteriaceae obtained with the MSDGN panel correlate well with MICs obtained using frozen reference panels using FDA interpretive criteria. * PROMPT(®) is a registered trademark of 3M Company, St. Paul, MN USA. Beckman Coulter, the stylized logo and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. Xerava™ (Eravacycline) is a registered trademark of Tetraphase Pharmaceuticals, Inc. [Image: see text] DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2019-10-23 /pmc/articles/PMC6810403/ http://dx.doi.org/10.1093/ofid/ofz360.1812 Text en © The Author(s) 2019. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Abstracts Traczewski, Maria M Beasley, Denise Harrington, Amanda DesJarlais, Sharon Garner, Omai Hastey, Christine Brookman, Regina Lockett, Zabrina Chau, Jennifer Zimmer, Barbara 2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels |
title | 2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels |
title_full | 2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels |
title_fullStr | 2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels |
title_full_unstemmed | 2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels |
title_short | 2132. Multicenter Evaluation of Eravacycline MIC Results for Enterobacteriaceae Using MicroScan Dried Gram-Negative MIC Panels |
title_sort | 2132. multicenter evaluation of eravacycline mic results for enterobacteriaceae using microscan dried gram-negative mic panels |
topic | Abstracts |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810403/ http://dx.doi.org/10.1093/ofid/ofz360.1812 |
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