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Clsi H26 A2  Form

Clsi H26 A2 Form

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welcome to this overview of clsi guideline ep26 user evaluation of acceptability of a reagent lot change second edition ep 26 includes recommendations for laboratories on evaluating a new reagent lot based on a protocol that uses patient samples to detect clinically important changes from the current lot changes in reagent lot performance may adversely affect patient results the protocol in ep26 attempts to balance the need to detect such changes with the fact that reagent lot verification is a relatively frequent task that places demands on the laboratory's limited resources ep 26 also provides guidance on determining whether lot-to-lot differences are significant and whether an observed difference is acceptable based on the established criteria ep26 describes a practical approach for screening new reagent lots for clinically significant performance changes using patient samples ep 26 also enables the laboratory to predict how effective the chosen protocol will be at detecting

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