ArticleThe AAPS journal2017
Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material.
Article in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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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
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Mapping molluscan endocrinology: a systematic and critical appraisal.Biological reviews of the Cambridge Philosophical Society · 2026Pooled it
- Context-of-use-Guided Development and Validation of a Transthyretin Immunoassay: A Framework for Biomarker Assay Design.The AAPS journal · 2026Article
- Quantitative immunohistochemistry and the use of cellular calibrators for HER2 receptor number determination.Scientific reports · 2026Article
- Best practices in the application of parallelism for biomarker assay validation.The AAPS journal · 2026Review
- Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays?The AAPS journal · 2025Article
- The case for calibration-free concentration analysis.Bioanalysis · 2025Article
- Challenges and advances for huntingtin detection in cerebrospinal fluid: in support of relative quantification.Biomarker research · 2025Article
- Overcoming Lot-to-Lot Variability in Protein Activity Using Epitope-Specific Calibration-Free Concentration Analysis.Analytical chemistry · 2024Article
- Biomarker Assay Validation by Mass Spectrometry.The AAPS journal · 2022Article
- Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays?The AAPS journal · 2022Article
- Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare-the Case for Surrogate Matrices.The AAPS journal · 2022Article
- Development of an LC-MS/MS Proposed Candidate Reference Method for the Standardization of Analytical Methods to Measure Lipoprotein(a).Clinical chemistry · 2021Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
As biomarkers continue to become an integral part of drug development and decision-making, there are increased expectations for reliable and quantitative assays. Protein biomarker assay results are directly influenced by the calibrator material. The selection of calibrator material presents many challenges that impact the relative accuracy and performance of the assay. There is an industry-wide challenge finding reliable and well-characterized calibrator material with good documentation. Several case studies are presented that demonstrate some of the challenges involved in selecting appropriate calibrators along with the resolutions that were ultimately applied. From these experiences, we present here a set of recommendations for selecting and characterizing calibrator material based on the intended purpose of the assay. Finally, we introduce a commutability approach, based on common clinical chemistry practices, which can be used to demonstrate inter-changeability with calibrator materials across multiple lots and technology platforms for all types of protein biomarker assays.
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Registered trials
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