Wallace F Morgan, Fallon Dawn, DeMarco Daniel, Varkey Stephen
DuPont Qualicon, Rt. 141 and Henry Clay Rd, DuPont Experimental Station, Wilmington, DE 19880-0400, USA.
J AOAC Int. 2011 May-Jun;94(3):863-71.
The new BAX System PCR Assay for Genus Listeria 24E was evaluated for detecting Listeria spp. in frankfurters, spinach, cooked shrimp, queso fresco cheese, and on stainless steel surfaces with a single-stage enrichment in BAX System 24 Listeria Enrichment Broth (24 LEB). Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent or superior to the U.S. Food and Drug Administration's Bacteriological Analytical Manual and the U.S. Department of Agriculture-Food Safety and Inspection Service culture methods, but with a significantly shorter time to result. Tests to evaluate inclusivity and exclusivity returned no false-negative and no false-positive results on a diverse panel of isolates, and tests for lot-to-lot variability and tablet stability demonstrated consistent performance. Ruggedness studies determined that none of the factors examined, within the range of deviations from specified parameters examined, affect the performance of the assay.
对用于检测李斯特菌属的新型BAX系统PCR检测方法24E进行了评估，该方法用于在法兰克福香肠、菠菜、熟虾、新鲜奶酪以及不锈钢表面检测李斯特菌属，采用在BAX系统24李斯特菌增菌肉汤（24LEB）中进行单阶段增菌的方法。对低接种量样品进行的方法比较研究表明，BAX系统显示出与美国食品药品监督管理局的《细菌学分析手册》以及美国农业部食品安全与检验局的培养方法相当或更高的灵敏度，但出结果的时间明显更短。评估包容性和排他性的测试在多种分离株上未产生假阴性和假阳性结果，批次间变异性和片剂稳定性测试显示性能一致。耐用性研究确定，在所检查的偏离指定参数的偏差范围内，所检查的因素均不影响该检测方法的性能。
