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dc.contributor.authorGoeres, Darla M.
dc.contributor.authorWalker, Diane K.
dc.contributor.authorBuckingham-Meyer, Kelli
dc.contributor.authorLorenz, Lindsey A.
dc.contributor.authorSummers, Jennifer
dc.contributor.authorFritz, Blaine
dc.contributor.authorGoveia, Danielle
dc.contributor.authorDickerman, Grace
dc.contributor.authorSchultz, Johanna M.
dc.contributor.authorParker, Albert E.
dc.identifier.citationGoeres, Darla M., Diane K. Walker, Kelli Buckingham-Meyer, Lindsey Lorenz, Jennifer Summers, Blaine Fritz, Danielle Goveia, Grace Dickerman, Johanna Schultz, and Albert E. Parker. “Development, Standardization, and Validation of a Biofilm Efficacy Test: The Single Tube Method.” Journal of Microbiological Methods 165 (October 2019): 105694. doi:10.1016/j.mimet.2019.105694.en_US
dc.description.abstractMethods validated by a standard setting organization enable public, industry and regulatory stakeholders to make decisions on the acceptability of products, devices and processes. This is because standard methods are demonstrably reproducible when performed in different laboratories by different researchers, responsive to different products, and rugged when small (usually inadvertent) variations from the standard procedure occur. The Single Tube Method (ASTM E2871) is a standard method that measures the efficacy of antimicrobials against biofilm bacteria that has been shown to be reproducible, responsive and rugged. In support of the reproducibility assessment, a six-laboratory study was performed using three antimicrobials: a sodium hypochlorite, a phenolic and a quaternary/alcohol blend, each tested at low and high efficacy levels. The mean log reduction in viable bacteria in this study ranged from 2.32 to 4.58 and the associated reproducibility standard deviations ranged from 0.89 to 1.67. Independent follow-up testing showed that the method was rugged with respect to deviations in sonication duration and sonication power but slightly sensitive to sonicator reservoir degassing and tube location within the sonicator bath. It was also demonstrated that when a coupon was dropped into a test tube, bacteria can splash out of reach of the applied antimicrobials, resulting in substantial bias when estimating log reductions for the products tested. Bias can also result when testing products that hinder the harvesting of microbes from test surfaces. The culmination of this work provided recommended changes to the early version of the standard method E2871-13 (ASTM, 2013b) including use of splashguards and microscopy checks. These changes have been incorporated into a revised ASTM method E2871-19 (ASTM 2019) that is the basis for the first regulatory method (ATMP-MB-20) to substantiate “kills biofilm” claims for antimicrobials registered and sold in the US.en_US
dc.rights©2019 This manuscript version is made available under the CC-BY-NC-ND 4.0 license
dc.titleDevelopment, standardization, and validation of a biofilm efficacy test: The single tube methoden_US
mus.citation.journaltitleJournal of Microbiological Methodsen_US
mus.relation.collegeCollege of Engineeringen_US
mus.relation.collegeCollege of Letters & Scienceen_US
mus.relation.departmentCenter for Biofilm Engineering.en_US
mus.relation.departmentMathematical Sciences.en_US
mus.relation.universityMontana State University - Bozemanen_US
mus.relation.researchgroupCenter for Biofilm Engineering.en_US

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©2019 This manuscript version is made available under the CC-BY-NC-ND 4.0 license
Except where otherwise noted, this item's license is described as ©2019 This manuscript version is made available under the CC-BY-NC-ND 4.0 license

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