Purpose: The purpose of this study was to conduct a method comparison evaluation of the bioMérieux TEMPO AC to the Health Canada MFHPB-18 reference method. The results of this study were collected according to Annex 3.1 of the Health Canada Compendium and submitted to the Health Canada Microbiological Methods Committee (MMC) in order to obtain the “all foods” claim for mesophilic aerobic bacteria for subsequent publication in the HC Compendium of Analytical Methods .Methods: The study consisted of analyzing five food categories, with one food type from each category being evaluated in a paired study design. Each food type was evaluated for naturally occurring mesophilic bacteria . The target range of contamination was achieved by diluting one lot of the matrix with high naturally occurring mesophilic bacterial counts with one lot of the matrix that produced lower counts in order to produce the target range of contamination. The validation study included evaluating 30 paired twenty-five (25) gram replicate samples in duplicate at six different levels of contamination.
Results: For each matrix evaluated, no statistically significant differences were determined between the alternative and reference methods.
Significance: Based on the results of the statistical analysis, the data generated in the evaluation support the claim that the TEMPO AC method is a comparable method to the MFHPB-18 and meets the requirements for the “all foods” claim for mesophilic aerobic bacteria. This method has been approved for publication in the HC Compendium of Analytical Methods.