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AOAC-OMA/MicroVal Harmonized Validation of Peel PlateTM EB (Enterobacteriaceae Bacteria), First Action 2018.05
Journal of AOAC INTERNATIONAL ( IF 1.6 ) Pub Date : 2020-06-17 , DOI: 10.1093/jaoacint/qsaa067
Robert S Salter 1 , Gregory W Durbin 1 , Denisse Martinez 1 , Patrick Bird 2 , Benjamin Bastin 2 , Erin Crowley 2
Affiliation  

Peel PlateTMEnterobacteriaceae Bacteria (EB) is dried selective media on a 47 mm plastic plate that produces enzyme substrate colored colonies on rehydration and incubation for 24 up to 48 h at 37 ± 1 °C. The method validation compared quantification of EB to reference methods, ISO 21528:2017 Parts 1 and 2. Matrices compared were whole milk, skim powdered milk, vanilla ice cream, butter, infant formulas (soy- and dairy-based), infant cereals ± probiotics, environmental sponge of stainless steel, and poultry carcass rinse with two different peptone buffers. In inclusivity and exclusivity studies, the method detected 54 of 54 EB strains and did not detect 30 of 30 non-EB strains. In matrix studies, the claimed foods were tested at three contamination levels using paired analysis between the reference and Peel Plate EB methods. Colony-forming units per gram or mL [CFU/g(mL)] were log10 transformed for statistical analysis. The candidate method and reference method were shown equivalent by the performance requirement of all 95% confidence intervals on mean difference falling between -0.5 and +0.5 log10 CFU/g(mL). An international collaborative study with dried infant formula spiked with Cronobacter sakazakii at log10 CFU/g(mL) 1.05, 2.31, and 3.21 levels, produced method differences -0.16, 0.15, and 0.18 log10 CFU/g(mL) with repeatabilities (r) = 0.33, 0.20, and 0.12 log10 CFU/g(mL) and reproducibilities (R) = 0.45, 0.26, and 0.18 log10 CFU/g(mL). Based on these evaluations, the candidate method is considered equivalent to the reference methods at both the 24 and 48 h incubation periods at 37 ± 1 °C.

中文翻译:

AOAC-OMA/MicroVal Peel PlateTM EB(肠杆菌科细菌)统一验证,首次行动 2018.05

Peel Plate TM肠杆菌科细菌 (EB) 是 47 mm 塑料板上干燥的选择性培养基,在复水并在 37 ± 1 °C 下孵育 24 至 48 小时时产生酶底物着色菌落。方法验证将 EB 定量与参考方法、ISO 21528:2017 第 1 部分和第 2 部分进行了比较。比较的基质为全脂牛奶、脱脂奶粉、香草冰淇淋、黄油、婴儿配方奶粉(大豆和乳制品)、婴儿谷物食品 ±益生菌、不锈钢环保海绵和家禽屠体用两种不同的蛋白胨缓冲液冲洗。在包容性和排他性研究中,该方法检测到了 54 种 EB 菌株中的 54 种,而没有检测到 30 种非 EB 菌株中的 30 种。在基质研究中,使用参考法和剥离板 EB 方法之间的配对分析,对所声称的食品进行了三个污染水平的测试。将每克或每毫升的菌落形成单位 [CFU/g(mL)] 进行 log 10转换以进行统计分析。所有 95% 置信区间的平均差值在 -0.5 和 +0.5 log10 CFU/g(mL) 之间的性能要求表明,候选方法和参考方法是等效的。一项国际合作研究,以 log 10 CFU/g(mL) 1.05、2.31 和 3.21 水平添加了坂崎克罗诺杆菌 (Cronobacter sakazakii) 的干婴儿配方奶粉,得出方法差异为 -0.16、0.15 和 0.18 log 10 CFU/g(mL),且具有重复性(r ) = 0.33、0.20 和 0.12 log 10 CFU/g(mL),重现性 ( R ) = 0.45、0.26 和 0.18 log 10 CFU/g(mL)。根据这些评估,候选方法被认为在 37 ± 1 °C 的 24 小时和 48 小时潜伏期与参考方法等效。
更新日期:2020-06-17
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