ReviewThe AAPS journal2016
Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.
Review in The AAPS journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
26 citing papers in PubMed.
- Blood-based multiplex nanobiosensing of Alzheimer's disease biomarkers: from nanoengineered ınterfaces to clinical translation.Metabolic brain disease · 2026Review
- Methodological approaches to account for assay changes in longitudinal biomarker analysis: insights from Alzheimer's blood biomarkers in the MEMENTO cohort.Alzheimer's research & therapy · 2026Article
- Speaking the same language: international cross-validation of emerging biomarkers for juvenile idiopathic arthritis and Still's Disease.Pediatric rheumatology online journal · 2026Article
- Validation of a Bead-Based Multiplex Assay for miRNA Quantification in Rat Liver Inflammation.ACS omega · 2026Article
- Best practices in the application of parallelism for biomarker assay validation.The AAPS journal · 2026Review
- Development and validation of a method for quantitation of CTx-1 for the assessment of biosimilarity of FKS518, a denosumab biosimilar.Bioanalysis · 2025Article
- Beyond Alzheimer's disease-translating biomarker insights across CNS diseases.Science translational medicine · 2025Review
- Plasma p-tau217 in Alzheimer's disease: Lumipulse and ALZpath SIMOA head-to-head comparison.Brain : a journal of neurology · 2025Article
- Overcoming Lot-to-Lot Variability in Protein Activity Using Epitope-Specific Calibration-Free Concentration Analysis.Analytical chemistry · 2024Article
- Immunoassays and Mass Spectrometry for Determination of Protein Concentrations in Genetically Modified Crops.Journal of agricultural and food chemistry · 2024Review
- Recent developments in mass-spectrometry-based targeted proteomics of clinical cancer biomarkers.Clinical proteomics · 2024Review
- A novel biomarker assay qualification strategy for rare human matrices - a case study of biomarkers in aqueous humor.Bioanalysis · 2024Review
- Validation of Sputum Biomarker Immunoassays and Cytokine Expression Profiles in COPD.Biomedicines · 2022Article
- Bayesian calibration, process modeling and uncertainty quantification in biotechnology.PLoS computational biology · 2022Article
- Differentiating iron-loading anemias using a newly developed and analytically validated ELISA for human serum erythroferrone.PloS one · 2021Article
- Retrospective and Prospective Look at Aflatoxin Research and Development from a Practical Standpoint.International journal of environmental research and public health · 2019Article
- Proteomic Approaches for the Discovery of Biofluid Biomarkers of Neurodegenerative Dementias.Proteomes · 2018Review
- miRNA-based signatures in cerebrospinal fluid as potential diagnostic tools for early stage Parkinson's disease.Oncotarget · 2018Article
- Article
- Evaluation of cerebrospinal fluid proteins as potential biomarkers for early stage Parkinson's disease diagnosis.PloS one · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Multiplex ligand binding assays (LBAs) are increasingly being used to support many stages of drug development. The complexity of multiplex assays creates many unique challenges in comparison to single-plexed assays leading to various adjustments for validation and potentially during sample analysis to accommodate all of the analytes being measured. This often requires a compromise in decision making with respect to choosing final assay conditions and acceptance criteria of some key assay parameters, depending on the intended use of the assay. The critical parameters that are impacted due to the added challenges associated with multiplexing include the minimum required dilution (MRD), quality control samples that span the range of all analytes being measured, quantitative ranges which can be compromised for certain targets, achieving parallelism for all analytes of interest, cross-talk across assays, freeze-thaw stability across analytes, among many others. Thus, these challenges also increase the complexity of validating the performance of the assay for its intended use. This paper describes the challenges encountered with multiplex LBAs, discusses the underlying causes, and provides solutions to help overcome these challenges. Finally, we provide recommendations on how to perform a fit-for-purpose-based validation, emphasizing issues that are unique to multiplex kit assays.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.