CLSI EP26

User Evaluation of Acceptability of a Reagent Lot Change, 2nd Edition

This guideline 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.

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Chairholder: Jesper V. Johansen, PhD

Date of Publication: April 27, 2022

Order Code PDF: CLSI EP26Ed2E
ISBN Number: 978-1-68440-138-3

Order Code Print: CLSI EP26Ed2
ISBN Number: 978-1-68440-137-6

Edition: Second

Pages: 122

CLSI EP26 Abstract

Clinical and Laboratory Standards Institute guideline EP26—User Evaluation of Acceptability of a Reagent Lot Change provides 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. It provides guidance on determining whether lot-to-lot differences are significant and whether an observed difference is acceptable based on the established criteria. The protocol attempts to balance the need to detect changes in reagent performance that may adversely affect patient results with the fact that reagent lot verification is a relatively frequent task that places demands on the laboratory’s limited resources. The more extensive initial setup of the protocol at the individual site is a one-time task performed in advance, making the subsequent testing of new reagent lots a straightforward procedure.

CLSI EP26

User Evaluation of Acceptability of a Reagent Lot Change, 2nd Edition

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CLSI EP26 Abstract