In this study to certify the BAX® for Screening/Listeria monocytogenes assay (DuPont Qualicon, Wilmington, DE), an internal evaluation was conducted on 16 food types that were simultaneously analyzed with the BAX system (BAX), and the ISO method for the detection of L. monocytogenes (ISO). No statistically significant difference in performance between the BAX and ISO methods was observed. Inclusivity/exclusivity testing showed that the BAX system was able to detect 97 of 97 (100%) of L. monocytogenes strains tested. None of 56 other Listeria species or non-Listeria tested gave a reproducible positive BAX result. Ruggedness testing demonstrated that performance of the assay was not affected by reasonable variability in the operating parameters. BAX was then submitted for independent laboratory validation. In this phase, BAX was compared with standard culture methods for the detection of L. monocytogenes in chicken (USDA-FSIS), crab meat (BAM), and milk (AOAC). This study validated product claims of sensitivity and specificity >98% in accordance with AOAC Performance Tested MethodSM requirements.

A dry-film coliform count plate that is inoculated with 5 mL sample was compared with the Violet Red Bile Agar plate method in a collaborative study by 18 laboratories. Products analyzed were 2% milk, chocolate milk, cream, vanilla ice cream, cottage cheese, and cheese. Collaborators tested blind duplicate uninoculated samples and samples inoculated at low, medium, and high level. Significantly (P< 0.05) higher numbers of coliforms were recovered by the dry-film method from 2% milk samples at the 3 inoculum levels, the chocolate milk at the low- and high-inoculum levels, and the cream at the high-inoculum level. Significantly higher counts were obtained by the agar method for cottage cheese samples at the low-inoculum level. The repeatability standard deviation for the dry-film method was significantly higher for the high-inoculum level chocolate milk sample and the medium-inoculum level cottage cheese. The same statistic was significantly higher for the agar method at all 3 inoculum levels in the 2% milk and the medium-inoculum level cream. The high-sensitivity dry rehydratable film method for enumeration of coliforms in dairy products has been adopted first action by AOAC INTERNATIONAL.