Document Detail

Development and validation of an ultra-sensitive method for the measurement of plasma renin activity in human plasma via LC-MS/MS.
MedLine Citation:
PMID:  23216124     Owner:  NLM     Status:  In-Data-Review    
Background: Renin catalyzes the conversion of angiotensinogen to angiotensin I (Ang I), the first and rate-limiting step in the renin-angiotensin-aldosterone system. Plasma renin activity (PRA) is an important target engagement biomarker in the clinical development of renin inhibitors. We have developed and validated an improved PRA assay that incorporates an Ang I trapping antibody followed by extraction and quantification of Ang I using a highly sensitive and specific LC-MS/MS method. Results: The following assay performance characteristics were assessed as part of analytical validation: precision, LOQ, spike recovery, dilution linearity, stability, absolute recovery and biological variability. The assay demonstrated excellent performance characteristics. Notably, the sensitivity of the assay was increased 140-fold when compared with a previous enzyme immunoassay-based assay. Conclusion: The improved sensitivity allowed the measurement of >95% PRA inhibition from baseline levels. In addition, we compared the LC-MS/MS-based assay to an enzyme immunoassay-based assay.
Derek L Chappell; Thomas McAvoy; Barbra Weiss; Russell Weiner; Omar F Laterza
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Bioanalysis     Volume:  4     ISSN:  1757-6199     ISO Abbreviation:  Bioanalysis     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101512484     Medline TA:  Bioanalysis     Country:  England    
Other Details:
Languages:  eng     Pagination:  2843-50     Citation Subset:  IM    
Clinical Development Laboratory, 126 E Lincoln Avenue, Rahway, NJ 07065, USA.
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