One assumes that the result obtained with the compendial method is absolute and is the “Gold Standard” by which to compare the new test. In reality, the compendial method exhibits a number of weaknesses that compromise the integrity of the validation.
The Gold Standard requires that:
- The media used for growth of microorganisms is consistent in formulation and performance.
- The operators have similar abilities to accurately count the colonies that develop on the plate surface.
- The specifications set and statistical methods used are consistent with and account for the natural variation in microbial testing.
The studies presented here investigate potential weaknesses of the compendial “Gold Standard” method that may compromise validation of new technologies.
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