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Background: Standard coliform count methods require preparation of agar, the use of pour-plate technique, the overlay of agar, and in some cases, the transfer of suspect colonies to broth medium for confirmation. The MC-Media Pad EC for enumeration of Escherichia coli and coliforms is a ready-to-use dehydrated sheet medium with no agar preparation, no spreader, and no confirmation step required. Objective: Using a paired study design, the MC-Media Pad EC was compared with standard method ISO 4832:2006. Ten matrixes including raw ground pork, raw chicken, cream, cream cheese, ready-to-cook vegetable mix, vegetable juice, cooked prawns, crab pâte, ham sandwiches, and cooked rice were evaluated in the study. Methods: Each matrix was tested at three levels of contamination (approximately 10², 10⁴, and 106 CFU/g). Five replicate 10 g test portions per level were tested in a paired comparison by the MC-Media Pad EC, ISO 4832:2006, and ISO 16649-2:2001 (Part 2) methods. In addition, inclusivity/exclusivity, robustness, and product consistency and stability were evaluated. Results: The candidate and reference methods demonstrated standard deviations ranging from 0.034 to 0.188 and 0.028 to 0.181, respectively, for E. coli counts and 0.047-0.188 and 0.025-0.157, respectively, for total coliforms. The difference of means ranged from -0.025 to 0.331 for E. coli and from -0.037 to 0.372 for total coliforms, showing no practical difference between the methods. The MC-Media Pad EC detected 49/50 E. coli and 60/63 coliform inclusivity strains and correctly excluded 30/32 exclusivity organisms for E. coli and 24/31 exclusivity organisms for total coliforms, which was similar to the reference method. Robustness testing demonstrated no significant change in results when small changes were made to sample volume, incubation temperature, and incubation time. The product consistency study demonstrated no significant difference between lots of product and supported the 1.5 year shelf life. Conclusions: The results support the conclusions that the MC-Media Pad EC is a suitable alternative to the ISO 4832:2006 and ISO 16649-2:2001 reference methods for the matrixes examined and the data support AOAC Performance Tested MethodSM certification. Highlights: The MC-Media Pad EC was approved for Performance Tested Method certification No. 011901. |
