Nissui Pharmaceutical Co., Ltd, 3-24-6 Ueno, Taito-ku, Tokyo 110-0005, Japan.
J AOAC Int. 2023 May 3;106(3):695-710. doi: 10.1093/jaoacint/qsac155.
CompactDry™ "Nissui" TCR are ready-to-use dry media sheets using a chromogenic medium for the enumeration of mesophilic aerobic bacteria in foods in as little as 24 h.
The CompactDry "Nissui" TCR method was validated to achieve AOAC Performance Tested MethodsSM certification.
The performance of the CompactDry "Nissui" TCR was compared to that of USDA/FSIS MLG 3.02, FDA BAM Chapter 3, and SMEDP Chapter 6 for 11 matrixes. All 11 matrixes were tested by CompactDry incubation at 35 ± 1°C for 24 ± 2 and 48 ± 3 h. The three dairy matrixes were also evaluated by CompactDry incubation at 32 ± 1°C for 24 ± 2 and 48 ± 3 h and additionally at 72 ± 3 h for nonfat dry milk.
After log10 transformation of the data, the standard deviation of repeatability (sr) was similar between CompactDry "Nissui" TCR and the respective reference methods, and method equivalence based on the 90% confidence interval of the difference of means being within (-0.5, 0.5) was demonstrated for all matrixes, incubation temperatures, and incubation times in the method developer and independent laboratory studies. The method was shown to be robust, and data are presented supporting product consistency and 18-month shelf life.
The CompactDry "Nissui" TCR method was validated for the determination of mesophilic aerobic bacteria in a variety of matrixes with incubation at 35 ± 1°C for 24 ± 2 and 48 ± 3 h and for dairy matrixes also at 32 ± 1°C for 24 ± 2, 48 ± 3, and 72 ± 3 h.
The CompactDry "Nissui" TCR method is equivalent to the USDA/FSIS MLG 3.02, FDA BAM Chapter 3, and SMEDP Chapter 6 reference methods and is suitable for Performance Tested MethodsSM certification for the matrixes tested.
“日水制药”CompactDry™ TCR 是一种即用型干片培养基，使用显色培养基，可在 24 小时内对食品中的需氧嗜温菌进行计数。
为了获得 AOAC 性能测试方法 SM 认证，对“日水制药”CompactDry™ TCR 方法进行了验证。
将“日水制药”CompactDry™ TCR 方法的性能与 USDA/FSIS MLG 3.02、FDA BAM 第 3 章和 SMEDP 第 6 章进行了比较，共对 11 种基质进行了检测。所有 11 种基质均在 35±1°C 下用 CompactDry 孵育 24±2 和 48±3 小时进行检测。三个乳制品基质也在 32±1°C 下用 CompactDry 孵育 24±2 和 48±3 小时以及非脂干乳在 72±3 小时进行检测。
对数据进行对数转换后，“日水制药”CompactDry™ TCR 与各自的参考方法的重复性标准偏差（sr）相似，并且基于均值差异的 90%置信区间，所有基质、孵育温度和孵育时间的方法等效性均在（-0.5，0.5）范围内，在方法开发人员和独立实验室研究中得到了证明。该方法具有稳健性，并且提供了支持产品一致性和 18 个月保质期的数据。
“日水制药”CompactDry™ TCR 方法经过验证，可用于各种基质中需氧嗜温菌的测定，在 35±1°C 下孵育 24±2 和 48±3 小时，以及在 32±1°C 下孵育 24±2、48±3 和 72±3 小时，用于乳制品基质。
“日水制药”CompactDry™ TCR 方法与 USDA/FSIS MLG 3.02、FDA BAM 第 3 章和 SMEDP 第 6 章参考方法等效，适用于所测试基质的性能测试方法 SM 认证。
