Wallace F Morgan, Burns Frank, Fleck Lois, Andaloro Bridget, Farnum Andrew, Tice George, Ruebl Joanne
DuPont Qualicon, ESL Bldg 400, PO 80400, Rt. 141 Henry Clay Rd, Wilmington, DE 19880-0400, USA.
J AOAC Int. 2010 May-Jun;93(3):928-35.
Evaluations were conducted to test the performance of the BAX System PCR assay which was certified as Performance Tested Method 010902 for screening yeast and mold in yogurt, corn starch, and milk-based powdered infant formula. Method comparison studies performed on samples with low-level inoculates showed that the BAX System demonstrates a sensitivity equivalent to the U.S. Food and Drug Administration's Bacteriological Analytical Manual culture method, but with a significantly shorter time to obtain results. 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 affected the performance of the assay.
进行了评估以测试BAX系统PCR检测法的性能，该检测法被认证为性能测试方法010902，用于筛查酸奶、玉米淀粉和以牛奶为基础的婴儿配方奶粉中的酵母和霉菌。对低水平接种样品进行的方法比较研究表明，BAX系统的灵敏度与美国食品药品监督管理局的《细菌学分析手册》培养法相当，但获得结果的时间明显更短。评估包容性和排他性的测试在不同的分离株面板上未产生假阴性和假阳性结果，并且批次间变异性和片剂稳定性测试显示性能一致。耐用性研究确定所检查的因素均未影响该检测法的性能。
