CLSI EP26-Ed2-IG:2022

CLSI EP26-Ed2-IG:2022

User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide, EP26-Ed2-IG

54,00 €


This implementation guide describes the minimum procedures necessary for a medical laboratory to verify that new reagent lots, when received and implemented by the laboratory, will produce results consistent with previous reagent lots. Reagent lot performance is validated by the developer before release and distribution, however, the laboratory needs to verify each new reagent lot it receives. Changes in performance with a new reagent lot could be due to:• Changes in reagent component materials• Instability of a component in a reagent• Reagents that were compromised in transportation or storage• Incorrect calibration of the new reagent lotVerifying that these potential changes have not occurred is important to ensure the quality of laboratory results. For additional information on the acceptability of a reagent lot change, see CLSI document EP26.1

Información adicional

Autor Clinical and Laboratory Standards Institute (CLSI)
Publicado por CLSI
Tipo de Documento Norma
Tema /subgroups/17901
EAN ISBN 9781684401390
Número de páginas 14
Palabra clave CLSI EP26-Ed2-IG