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本文引用的文献

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Confirmation and Identification of spp., spp., and Other Gram-Negative Organisms by the Bruker MALDI Biotyper Method: Collaborative Study Method Extension to Include Species, Revised First Action 2017.09.采用布鲁克基质辅助激光解吸电离生物分型方法对[具体菌属]菌、[具体菌属]菌及其他革兰氏阴性菌进行确认和鉴定:合作研究方法扩展至包括[具体菌种],2017年9月修订的首次行动。
J AOAC Int. 2019 Sep 1;102(5):1595-1616. doi: 10.5740/jaoacint.18-0329. Epub 2019 May 3.
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Confirmation and Identification of spp. and Other Gram-Positive Organisms by the Bruker MALDI Biotyper Method: Collaborative Study, First Action 2017.10.采用布鲁克基质辅助激光解吸电离飞行时间质谱法对[具体菌名]属及其他革兰氏阳性菌进行确认和鉴定:协作研究,首次行动,2017年10月
J AOAC Int. 2018 Sep 1;101(5):1610-1622. doi: 10.5740/jaoacint.18-0013. Epub 2018 Apr 27.
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Probability of Detection (POD) as a statistical model for the validation of qualitative methods.检测概率(POD)作为定性方法验证的统计模型。
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3M™ 环境擦拭取样器与广谱中和剂的验证:AOAC 性能测试方法 SM022104。

Validation of the 3M™ Environmental Scrub Sampler with Wide-Spectrum Neutralizer: AOAC Performance Tested MethodSM 022104.

机构信息

3M Company, Food Safety Department, St. Paul, MN 55144-1000, USA.

Microbiology Research and Development, Q Laboratories, 1930 Radcliff Drive, Cincinnati, OH 45204, USA.

出版信息

J AOAC Int. 2022 Apr 27;105(3):876-888. doi: 10.1093/jaoacint/qsab136.

DOI:10.1093/jaoacint/qsab136
PMID:34677576
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9046969/
Abstract

BACKGROUND

The 3M™ Environmental Scrub Sampler with 10 mL Wide Spectrum Neutralizer is a nonspecific sampling device intended for use for environmental monitoring surface sampling.

OBJECTIVE

The aim was to evaluate 3M Wide Spectrum Neutralizer using the 3M Environmental Scrub Sampler for AOAC® Performance Tested MethodsSM (PTM) certification.

METHODS

Matrix studies, inclusivity/exclusivity, product consistency/stability, neutralization, and robustness testing were conducted for Salmonella and Listeria species. Stainless steel, sealed concrete, and plastic environmental surfaces were evaluated in the matrix study comparing the performance of the 3M™ method for sample collection to that of the U.S. Food and Drug Administration (FDA) Bacteriological Analytical Manual (BAM) reference methods. Four classes of sanitizers, namely quaternary ammonium, high acid, hydrogen/peroxyacetic acid and chlorine/bleach-based, were assessed in the neutralization study following ASTM E1054 - 08, Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents. The other testing parameters followed typical PTM study design.

RESULTS

In matrix studies the 3M sampling device demonstrated no significant differences between candidate and reference sampling method results. All inclusivity organisms were detected, and all exclusivity organisms were excluded, for both Salmonella and Listeria strains when tested by the appropriate FDA BAM detection method. Robustness, product consistency, and stability studies showed that the sampling device is not affected by lot or testing parameter differences. The Wide Spectrum Neutralizer was proven to effectively neutralize sanitizers at the concentrations tested and was itself shown to be nontoxic and did not affect target microorganism recovery.

CONCLUSIONS

The 3M Environmental Scrub Sampler with 10 mL Wide Spectrum Neutralizer is an effective, stable, robust sampling device for the recovery of Salmonella spp. and Listeria spp.

HIGHLIGHT

The 3M Environmental Scrub Sampler with 10 mL Wide Spectrum Neutralizer is an acceptable sampling device for use in FDA BAM Salmonella and Listeria reference methods.

摘要

背景

3M™ 环境擦拭采样器搭配 10mL 广谱中和剂是一种非特异性采样设备,旨在用于环境监测表面采样。

目的

本研究旨在使用 3M 环境擦拭采样器对 3M 广谱中和剂进行广谱中和剂评估,以符合 AOAC® 性能测试方法 SM(PTM)认证。

方法

进行了基质研究、包容性/排他性、产品一致性/稳定性、中和及稳健性测试,以评估沙门氏菌和李斯特菌。在基质研究中,对不锈钢、密封混凝土和塑料环境表面进行了评估,比较了 3M 方法对样本采集的性能与美国食品和药物管理局(FDA)细菌分析手册(BAM)参考方法的性能。在中和研究中,根据 ASTM E1054-08《抗菌剂消毒剂评价的标准测试方法》,评估了四类消毒剂,即季铵盐、高酸、氢过氧乙酸和氯/漂白剂。其他测试参数遵循典型的 PTM 研究设计。

结果

在基质研究中,3M 采样器候选采样方法与参考采样方法的结果之间没有显著差异。在通过适当的 FDA BAM 检测方法进行测试时,所有包容性生物体都被检测到,所有排他性生物体都被排除,无论是沙门氏菌还是李斯特菌菌株。稳健性、产品一致性和稳定性研究表明,采样器不受批次或测试参数差异的影响。广谱中和剂被证明能有效中和测试浓度的消毒剂,本身无毒性,且不影响目标微生物的回收。

结论

3M 环境擦拭采样器搭配 10mL 广谱中和剂是一种有效的、稳定的、稳健的采样设备,可用于回收沙门氏菌和李斯特菌。

重点

3M 环境擦拭采样器搭配 10mL 广谱中和剂是一种可接受的采样设备,可用于 FDA BAM 沙门氏菌和李斯特菌参考方法。