Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift

Quality controls (QCs) are the primary indices of assay performance and an important tool in assay lifecycle management. Inclusion of QCs in the testing process allows for the detection of system errors and ongoing assessment of the reliability of the assay. Changes in the performance of QCs are ind...

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Autores principales: Azadeh, Mitra, Sondag, Perceval, Wang, Ying, Raines, Maribeth, Sailstad, Jeffrey
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
White Paper
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647453/
https://www.ncbi.nlm.nih.gov/pubmed/31297703
http://dx.doi.org/10.1208/s12248-019-0354-6
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author Azadeh, Mitra
Sondag, Perceval
Wang, Ying
Raines, Maribeth
Sailstad, Jeffrey
author_facet Azadeh, Mitra
Sondag, Perceval
Wang, Ying
Raines, Maribeth
Sailstad, Jeffrey
author_sort Azadeh, Mitra
collection PubMed
description Quality controls (QCs) are the primary indices of assay performance and an important tool in assay lifecycle management. Inclusion of QCs in the testing process allows for the detection of system errors and ongoing assessment of the reliability of the assay. Changes in the performance of QCs are indicative of changes in the assay behavior caused by unintended alterations to reagents or to the operating conditions. The focus of this publication is management of QC life cycle. A consensus view of the ligand binding assay (LBA) community on the best practices for factors that are critical to QC life cycle management including QC preparation, qualification, and trending is presented here. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1208/s12248-019-0354-6) contains supplementary material, which is available to authorized users.
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spelling pubmed-66474532019-08-06 Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift Azadeh, Mitra Sondag, Perceval Wang, Ying Raines, Maribeth Sailstad, Jeffrey AAPS J White Paper Quality controls (QCs) are the primary indices of assay performance and an important tool in assay lifecycle management. Inclusion of QCs in the testing process allows for the detection of system errors and ongoing assessment of the reliability of the assay. Changes in the performance of QCs are indicative of changes in the assay behavior caused by unintended alterations to reagents or to the operating conditions. The focus of this publication is management of QC life cycle. A consensus view of the ligand binding assay (LBA) community on the best practices for factors that are critical to QC life cycle management including QC preparation, qualification, and trending is presented here. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1208/s12248-019-0354-6) contains supplementary material, which is available to authorized users. Springer International Publishing 2019-07-11 /pmc/articles/PMC6647453/ /pubmed/31297703 http://dx.doi.org/10.1208/s12248-019-0354-6 Text en © The Author(s) 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle White Paper
Azadeh, Mitra
Sondag, Perceval
Wang, Ying
Raines, Maribeth
Sailstad, Jeffrey
Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
title Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
title_full Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
title_fullStr Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
title_full_unstemmed Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
title_short Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift
title_sort quality controls in ligand binding assays: recommendations and best practices for preparation, qualification, maintenance of lot to lot consistency, and prevention of assay drift
topic White Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647453/
https://www.ncbi.nlm.nih.gov/pubmed/31297703
http://dx.doi.org/10.1208/s12248-019-0354-6
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