CLSI EP26-A-2013 试剂批间差异的用户评价.pdf

C L S I e C L I P S E - U s e r S i e m e n s - September 2013 S i e m e n s H e a l t h c a r e D EP26-A i a g n o s t i c s I n c. User Evaluation of Between-Reagent Lot - 0 4 / 2 5 Variation; Approved Guideline / 2 0 1 7 . U n a u t h o r i z e d d u p l i c a t i o n o r n e t w o r k s h a r i n g i s n o t a l l o w e d . This document provides guidance for laboratories on the evaluation of a new reagent lot, including a protocol using patient samples to detect significant changes from the current lot. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. C L S I e C L I P S E - Clinical and Laboratory Standards Institute U s Setting the standard for quality in medical laboratory testing around the world. e r S i e m The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings e n s together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a - S common cause: to foster excellence in laboratory medicine by developing and implementing medical laboratory i e m e standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global n s applicability. H e a l t h c a Consensus Process r e D i a Consensus—the substantial agreement by materially affected, competent, an