EP26-A provides users with a protocol to evaluate the consistency of patient sample results when a new analytical reagent lot replaces a reagent lot currently in use. It also helps users detect significant changes in measurement procedure performance for patient samples due to reagent lot changes, and confirms that patient sample results are consistent between two reagent lots.
CLSI Published a New Method Evaluation Guideline: EP26-A—User Evaluation of Between-Reagent Lot Variation
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Art and Science of Laboratory Medicine