PROTOCOL FOR THE VALIDATION OF QUANTITATIVE ALTERNATIVE METHODS OF MICROBIOLOGY

Background and Aim:Today, many alternative, mostly proprietary, methods exist that are used to assess the microbiological quality of raw materials and finished products and the microbiological status of manufacturing procedures. These methods are often faster and easier to perform than the corresponding standardized method.Methods:It consists of four parts. — A comparative study of the results of the reference method to the results of the alternative method in a variety of different items (naturally and/or artificially) contaminated samples. — A comparative study of the results of the reference method to the results of the alternative method in artificially contaminated samples using replicates of a single item per category. — A limit of quantification (LOQ) study of the results of the alternative method in artificially contaminated samples using replicates of a single item per category. The data are used to calculate the LOQ of the alternative method. This study is only done for instrumentally-based methods — An inclusivity/exclusivity study of the alternative method.Results:The results obtained are analysed using the Bland-Altman method.Plot the data for each sample per category and for each sample in all categories and draw the line of identity on which all points would lie if the two methods gave identical results for each sample analysed.The alternative method is accepted as being equivalent to the reference method if it is equivalent for all individual and combined categories.Conclusion:This article determines general principle and the technical protocol for the validation of quantitative alternative methods for microbiology in the food chain.

Keywords:

Validation , Alternative methods , Refrence method , Quantitative methods