Technical Validation for Food Microbiological Testing Methods
Objective:To explore the technical validation procedures for microbial testing methods,and provide reference and guidance for inspection and testing institutions.Method:Taking Vibrio parahaemolyticus test method as an example,the basic verification mode of food microbiological test method was established through the control of method verification elements,and the test method was verified from the aspects of detection level,estimation deviation,precision and uncertainty evaluation.Result:The qualitative detection levels of aquatic products and seasonings were 2 CFU/test unit and 3 CFU/test unit,respectively,which were lower than the estimated detection levels.The estimated deviations for different concentration levels are 0.35 lgCFU·g-1,0.27 lgCFU·g-1,and 0.24 lgCFU·g-1,all of which are less than 0.5 lgCFU·g-1.The repeatability standard deviation is 0.113 8%,which is less than the reproducibility standard deviation of 0.18%.The extended uncertainty of the method is 0.22 lgMPN·g-1(k=2,confidence probability of 95%).Conclusion:The experiment constructed a basic model for verifying the detection method of Vibrio parahaemolyticus from the aspects of detection level,estimation deviation,precision,and uncertainty evaluation.The verification results were satisfactory,and an uncertainty evaluation plan was provided,providing reference for the laboratory to formulate judgment rules.
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