1. New approaches for biomarker stability determination in regulated bioanalysis: trending, bridging and incurred samples.
- Author
-
Kar S and Islam C
- Subjects
- Arginase chemistry, Arginase metabolism, Biomarkers chemistry, Humans, Interleukin-13 Receptor alpha1 Subunit analysis, Interleukin-13 Receptor alpha1 Subunit chemistry, Protein Stability, Quality Control, Sputum enzymology, Statistics as Topic, Transforming Growth Factor beta1 analysis, Transforming Growth Factor beta1 chemistry, Biomarkers analysis, Chemistry Techniques, Analytical methods
- Abstract
Aim: Determining the stability of biomarkers continues to present challenges. Disease states, complex matrices and differences between recombinant and endogenous analytes require new approaches to maintain stability and measure it. In this report, we determine stability for two assays using trending and statistical analysis. Methodology & results: Monitoring trends helps identify out of specification measurements and determine whether concerns are due to the stability of the analyte. We also describe challenges presented when measuring arginase activity in human sputum, a complex matrix, for respiratory diseases. We controlled preanalytical protease activity and collection heterogeneity and monitored incurred sample stability to improve stability of arginine. Conclusion: These new approaches to achieving and determining biomarker stability may provide solutions for increasingly complex biomarker measurements.
- Published
- 2019
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