ArticleThe AAPS journal2019
Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift.
Article in The AAPS journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Who cites it
14 citing papers in PubMed.
- Oxidized carbon black nanoparticles as color label in a rapid vertical flow immunoassay for C-reactive protein detection.Analytical and bioanalytical chemistry · 2026Article
- Use of Incurred Sample Reproducibility Data to Support Long Term Stability of Therapeutic Antibodies in Clinical Bioanalytical Methods.AAPS PharmSciTech · 2026Article
- Reference Standard Calibration Challenges in the Case of Erythropoietin: Impact on Potency and Biosimilarity Determination.The AAPS journal · 2025Article
- Development and validation of a method for quantitation of CTx-1 for the assessment of biosimilarity of FKS518, a denosumab biosimilar.Bioanalysis · 2025Article
- Evaluation of singlicateBioanalysis · 2025Article
- Neutralizing Antibody Sample Testing and Report Harmonization.The AAPS journal · 2024Article
- Development and performance of NLISA for C-reactive protein detection based on Prussian blue nanoparticle conjugates.Analytical and bioanalytical chemistry · 2024Article
- Overcoming Lot-to-Lot Variability in Protein Activity Using Epitope-Specific Calibration-Free Concentration Analysis.Analytical chemistry · 2024Article
- Comprehensive performance evaluation of ligand-binding assay-LC-MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442).Bioanalysis · 2024Article
- Anti-drug Antibody Sample Testing and Reporting Harmonization.The AAPS journal · 2022Article
- Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?The AAPS journal · 2022Article
- Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays.The AAPS journal · 2021Review
- Assessing the calibration in toxicological in vitro models with conformal prediction.Journal of cheminformatics · 2021Article
- Modernization of Control of Pathogenic Micro-Organisms in the Food-Chain Requires a Durable Role for Immunoaffinity-Based Detection Methodology-A Review.Foods (Basel, Switzerland) · 2021Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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