Whole blood stability in quantitative bioanalysis

Establishing stability at all stages of a sample’s lifespan is a critical part of performing regulated bioanalysis. For plasma assays, this includes the duration between when blood is drawn and when that blood is centrifuged to produce plasma. Here, we provide a discussion of current regulatory expe...

Full description

Saved in:
Bibliographic Details
Published in:Bioanalysis 2019-10, Vol.11 (20), p.1885-1897
Main Authors: Ledvina, Aaron R, Ewles, Matthew, Pang, Yongle, Cape, Stephanie
Format: Article
Language:English
Subjects:
Blood
Design
LC–MS/MS
Life span
Plasma
plasma-whole blood partitioning
regulated bioanalysis
Regulatory agencies
stability
whole blood stability
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Establishing stability at all stages of a sample’s lifespan is a critical part of performing regulated bioanalysis. For plasma assays, this includes the duration between when blood is drawn and when that blood is centrifuged to produce plasma. Here, we provide a discussion of current regulatory expectations around whole blood stability testing for LC–MS plasma assays, as well as the two primary experimental approaches utilized to assess whole blood stability. Next, we interrogated a large dataset of validated methods (1076 methods, the vast majority of which were for measurement of small molecules) to assess the correlation between whole blood and plasma stability profiles, finding them to be highly correlated. Finally, we summarize unique case studies; we have encountered during WB stability testing which offer lessons that may be broadly applicable.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2019-0155