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Question/Comment-6
A section should be added to all validations that describes the method limitations. For
instance, if a kit manufacturer realizes their egg assay works well for raw egg but not
cooked, in addition to only validating the kit for unheated foods, there should also be a
statement that the kit is not suitable for testing cooked products. Similarly if the kit
works well in some matrices but not others, this should be stated in the validation,
since labs tend to take AOAC methods and use them for every situation.