Cargando…
Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101
BACKGROUND: The MYChrOme™ Culture Plate is a chromogenic media for the detection and differentiation of rapid-growing nontuberculous mycobacteria (NTM) in water, aided by MYCOn™ decontamination to reduce background microbiota. OBJECTIVE: Evaluate the MYChrOme Culture Plates for the detection of rapi...
Autores principales: | , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8924644/ https://www.ncbi.nlm.nih.gov/pubmed/34297095 http://dx.doi.org/10.1093/jaoacint/qsab093 |
_version_ | 1784669904246407168 |
---|---|
author | Fisher, Katherine E Chhabra, Avneet K Wickenberg, Leah P McCoy, William F |
author_facet | Fisher, Katherine E Chhabra, Avneet K Wickenberg, Leah P McCoy, William F |
author_sort | Fisher, Katherine E |
collection | PubMed |
description | BACKGROUND: The MYChrOme™ Culture Plate is a chromogenic media for the detection and differentiation of rapid-growing nontuberculous mycobacteria (NTM) in water, aided by MYCOn™ decontamination to reduce background microbiota. OBJECTIVE: Evaluate the MYChrOme Culture Plates for the detection of rapid-growing NTM in potable and non-potable water as part of the AOAC Performance Tested Method(s)(SM) program. METHODS: Inclusivity and exclusivity of MYChrOme were evaluated with 50 target and 30 non-target organisms. Method robustness and lot stability of MYChrOme were analyzed. The candidate method was compared to a modified US Food and Drug Administration (FDA) Method: U.S. FDA—Isolation and Identification of Nontuberculous Mycobacteria in Tattoo Inks using an equivalency test. The matrix study consisted of artificially contaminated potable water and naturally contaminated non-potable water. Independent laboratory testing was conducted to verify method performance in non-potable water. RESULTS: The inclusivity of MYChrOme was 94% within one week, and 98% within two weeks. The exclusivity was 96% for untreated samples and 100% for treated samples. The candidate method remained statistically equivalent for robustness and a three-month shelf-life was confirmed. For both matrixes, the candidate and reference methods were not equivalent, with more colonies enumerated on the candidate method except for one contamination level of the potable matrix. CONCLUSION: The MYChrOme culture method can successfully detect and differentiate rapid-growing NTM in the matrixes tested, with sensitivity equivalent or higher than the reference method. HIGHLIGHTS: The MYChrOme culture plate offers differentiation of rapid-growing NTM colonies, improved detection in non-potable samples with MYCOn decontamination, and results within 7 days. |
format | Online Article Text |
id | pubmed-8924644 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-89246442022-03-17 Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101 Fisher, Katherine E Chhabra, Avneet K Wickenberg, Leah P McCoy, William F J AOAC Int Microbiological Methods BACKGROUND: The MYChrOme™ Culture Plate is a chromogenic media for the detection and differentiation of rapid-growing nontuberculous mycobacteria (NTM) in water, aided by MYCOn™ decontamination to reduce background microbiota. OBJECTIVE: Evaluate the MYChrOme Culture Plates for the detection of rapid-growing NTM in potable and non-potable water as part of the AOAC Performance Tested Method(s)(SM) program. METHODS: Inclusivity and exclusivity of MYChrOme were evaluated with 50 target and 30 non-target organisms. Method robustness and lot stability of MYChrOme were analyzed. The candidate method was compared to a modified US Food and Drug Administration (FDA) Method: U.S. FDA—Isolation and Identification of Nontuberculous Mycobacteria in Tattoo Inks using an equivalency test. The matrix study consisted of artificially contaminated potable water and naturally contaminated non-potable water. Independent laboratory testing was conducted to verify method performance in non-potable water. RESULTS: The inclusivity of MYChrOme was 94% within one week, and 98% within two weeks. The exclusivity was 96% for untreated samples and 100% for treated samples. The candidate method remained statistically equivalent for robustness and a three-month shelf-life was confirmed. For both matrixes, the candidate and reference methods were not equivalent, with more colonies enumerated on the candidate method except for one contamination level of the potable matrix. CONCLUSION: The MYChrOme culture method can successfully detect and differentiate rapid-growing NTM in the matrixes tested, with sensitivity equivalent or higher than the reference method. HIGHLIGHTS: The MYChrOme culture plate offers differentiation of rapid-growing NTM colonies, improved detection in non-potable samples with MYCOn decontamination, and results within 7 days. Oxford University Press 2021-07-23 /pmc/articles/PMC8924644/ /pubmed/34297095 http://dx.doi.org/10.1093/jaoacint/qsab093 Text en © AOAC INTERNATIONAL 2021. https://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 (https://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 | Microbiological Methods Fisher, Katherine E Chhabra, Avneet K Wickenberg, Leah P McCoy, William F Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101 |
title | Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101 |
title_full | Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101 |
title_fullStr | Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101 |
title_full_unstemmed | Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101 |
title_short | Validation of the MYChrOme™ Culture Plate for Detection and Differentiation of Rapid-Growing Nontuberculous Mycobacteria in Potable and Non-Potable Water: AOAC Performance Tested Method(SM) 062101 |
title_sort | validation of the mychrome™ culture plate for detection and differentiation of rapid-growing nontuberculous mycobacteria in potable and non-potable water: aoac performance tested method(sm) 062101 |
topic | Microbiological Methods |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8924644/ https://www.ncbi.nlm.nih.gov/pubmed/34297095 http://dx.doi.org/10.1093/jaoacint/qsab093 |
work_keys_str_mv | AT fisherkatherinee validationofthemychromecultureplatefordetectionanddifferentiationofrapidgrowingnontuberculousmycobacteriainpotableandnonpotablewateraoacperformancetestedmethodsm062101 AT chhabraavneetk validationofthemychromecultureplatefordetectionanddifferentiationofrapidgrowingnontuberculousmycobacteriainpotableandnonpotablewateraoacperformancetestedmethodsm062101 AT wickenbergleahp validationofthemychromecultureplatefordetectionanddifferentiationofrapidgrowingnontuberculousmycobacteriainpotableandnonpotablewateraoacperformancetestedmethodsm062101 AT mccoywilliamf validationofthemychromecultureplatefordetectionanddifferentiationofrapidgrowingnontuberculousmycobacteriainpotableandnonpotablewateraoacperformancetestedmethodsm062101 |