Kerr David E, Shen George, Lienau Andrew H, Deng Ta, Kaur Mandeep, Immermann Amy L, Feldsine Philip T, John Lisa, Chen Yi, Brodsky Michael, Ziemer Wayne
BioControl Systems, Inc., 12822 SE 32nd St, Bellevue, WA 98005.
U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy, Rm 3E-021, College Park, MD 20740.
J AOAC Int. 2019 May 1;102(3):828-841. doi: 10.5740/jaoacint.18-0312. Epub 2018 Nov 19.
TRANSIA PLATE Gold is an ELISA that was validated by Association Française de Normalisation (AFNOR) in 2001 and as a (PTM) by AOAC in 2006 (PTM No. 010602) as a two-step enrichment protocol requiring 48 h. A simple next-day enrichment protocol using modified Enterohemorrhagic media was developed for the TRANSIA PLATE Gold to improve the time-to-results and laboratory work flow. We tested 128 strains, representing all serotypes from A though Z and 51-66. TRANSIA PLATE Gold detected all 128 of these strains. None of the 50 non- strains were detected by TRANSIA PLATE Gold. Performance of TRANSIA PLATE Gold using the new enrichment protocol was compared with U.S. Department of Agriculture reference culture procedure for the detection of Salmonella in ready-to-eat poultry, ready-to-eat beef, and chicken carcass rinsate. In addition, TRANSIA PLATE Gold performance was compared with U.S. Food and Drug Administration (FDA) (BAM) for the detection of from raw spinach, raw almonds, raw pasta, and environmental surfaces (stainless steel, rubber, and plastic). There was no statistically significant difference in the numbers of positive results TRANSIA PLATE Gold protocol compared with the appropriate U.S. Department of Agriculture Food Safety and Inspection Service or FDA-BAM reference methods for any of these matrixes. Robustness testing demonstrated that the introduction of small changes in the normal assay parameters had no impact on the method performance. This new enrichment protocol has been approved as a Third Level modification to 010602.
TRANSIA PLATE Gold是一种酶联免疫吸附测定法，于2001年得到法国标准化协会（AFNOR）的验证，并于2006年被美国官方分析化学师协会（AOAC）认定为性能验证方法（PTM编号010602），这是一种需要48小时的两步富集方案。针对TRANSIA PLATE Gold开发了一种使用改良的出血性大肠杆菌培养基的简单次日富集方案，以缩短出结果时间并优化实验室工作流程。我们检测了128株菌株，涵盖从A到Z以及51 - 66的所有血清型。TRANSIA PLATE Gold检测出了所有这128株菌株。50株非目标菌株均未被TRANSIA PLATE Gold检测到。将采用新富集方案的TRANSIA PLATE Gold的性能与美国农业部用于即食家禽、即食牛肉和鸡胴体冲洗液中沙门氏菌检测的参考培养程序进行了比较。此外，还将TRANSIA PLATE Gold的性能与美国食品药品监督管理局（FDA）的《细菌分析手册》（BAM）用于生菠菜、生杏仁、生面食和环境表面（不锈钢、橡胶和塑料）中目标菌检测的性能进行了比较。与美国农业部食品安全检验局或FDA - BAM针对任何这些基质的适当参考方法相比，TRANSIA PLATE Gold方案的阳性结果数量没有统计学上的显著差异。稳健性测试表明，在正常检测参数中引入小的变化对方法性能没有影响。这种新的富集方案已被批准作为对010602的三级修改。
