Feldsine P T, Falbo-Nelson M T, Hustead D L, Flowers R S, Flowers M J
BioControl Systems, Inc., Bothell, WA 98011, USA.
J AOAC Int. 1995 Jul-Aug;78(4):987-92.
The single enrichment immunodiffusion (1-step), the preenrichment and selective enrichment immunodiffusion (2-step), and the AOAC/Bacteriological Analytical Manual culture methods for Salmonella were evaluated for equivalence in 2 separate studies, a comparative evaluation and a multilaboratory dilution study. In the comparative study, all 3 methods were performed on 10 food types. For 550 samples, analyses resulted in 99.3 and 99.6% agreement between the culture method and the 1-step and 2-step methods, respectively. False negative rates were 0.9 and 0.3% for 1-step and culture, and 0.0% and 0.6% for the 2-step and culture, respectively. Subsequently, 6 food types were included in a multilaboratory dilution-to-extinction study. A sequential dilution series of Salmonella in foods was analyzed by the 3 methods to determine their lower limits of detection for Salmonella. A total of 1185 samples analyzed resulted in 98.9% agreement between 1-step and culture, and 99.7% agreement between 2-step and culture. False negative rates were 1.8 and 0.1% for 1-step and culture, and 0.4 and 0.1% for 2-step and culture, respectively. During these evaluations, 1735 samples and controls representing 10 different naturally contaminated and inoculated foods were tested. The data indicate statistical equivalence of all 3 methods when analyzing all food types.
在两项独立研究中，即一项比较评估研究和一项多实验室稀释研究中，对用于沙门氏菌检测的单步富集免疫扩散法（一步法）、预富集和选择性富集免疫扩散法（两步法）以及美国公职分析化学家协会/《细菌学分析手册》培养方法进行了等效性评估。在比较研究中，对10种食品类型均采用了这三种方法。对于550个样本的分析结果显示，培养法与一步法及两步法之间的一致性分别为99.3%和99.6%。一步法与培养法的假阴性率分别为0.9%和0.3%，两步法与培养法的假阴性率分别为0.0%和0.6%。随后，在一项多实验室稀释至灭绝研究中纳入了6种食品类型。通过这三种方法对食品中沙门氏菌的连续稀释系列进行分析，以确定它们对沙门氏菌的最低检测限。对总共1185个样本的分析结果显示，一步法与培养法之间的一致性为98.9%，两步法与培养法之间的一致性为99.7%。一步法与培养法的假阴性率分别为1.8%和0.1%，两步法与培养法的假阴性率分别为0.4%和0.1%。在这些评估过程中，对代表10种不同天然污染和接种食品的1735个样本及对照进行了检测。数据表明，在分析所有食品类型时，这三种方法在统计学上具有等效性。
