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Abstract P251: Assay Performance And System Compatibility For RAAS Triple-A Analysis In Hypertension Profiling
- Source :
- Hypertension. 79
- Publication Year :
- 2022
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2022.
-
Abstract
- Recent studies revealed major concerns related to the accuracy of widely used clinical assays for aldosterone and renin, fueling the need for alternative and more robust bio-analytical solutions for assessment of the Renin-Angiotensin-Aldosterone-System (RAAS) in clinical samples. RAAS Triple-A profiling is a high-throughput mass-spectrometry based assay for quantification of Angiotensin I (Ang I), Angiotensin II (Ang II) and Aldosterone in serum samples. Quantified hormone levels are used to calculate markers for plasma-renin-activity (PRA-S), plasma angiotensin-converting-enzyme activity (ACE-S) and adrenal aldosterone secretion (AA2-Ratio), which can be used for clinical profiling in patients with uncontrolled hypertension. A RAAS Triple-A LC-MS/MS kit was recently launched as an In Vitro Diagnostic (IVD) device in Europe for hypertension profiling. In the current study, a comparative approach was used to assess analytical performance of the RAAS Triple-A assay on three different LC-MS/MS systems, Altis+ (Thermo Scientific), Xevo TQ-S (Waters), and Triple Quad 6500+ (Sciex) located in three different laboratories. RAAS Triple-A kits (96-well format) were used to analyze one set of n=50 triplicate human serum samples at each location. At each site, samples were sample preparation and LC-MS/MS analysis according to the RAAS Triple-A kit manual. Analytical validation of assay linearity, precision, and accuracy were evaluated at each site, and Bland-Altman-Analysis was used to test for quantification bias between sites. Results demonstrate the measured concentrations for each analyte, Ang I, Ang II, and aldosterone, were strongly correlated between sites (R 2 = Ang I: 0.996; Ang II: 0.991; Aldo: 0.983). Performance characteristics of all target analytes were in compliance with European Medical Agency (EMA) standards for bio-analytical assays on each instrument. Robust assay performance across laboratories and different LC-MS/MS systems allows for a broad clinical application of RAAS Triple-A profiling potentially improving treatment efficacy in hypertension by supporting treatment decisions with individual RAAS Triple-A profiles.
- Subjects :
- Internal Medicine
Subjects
Details
- ISSN :
- 15244563 and 0194911X
- Volume :
- 79
- Database :
- OpenAIRE
- Journal :
- Hypertension
- Accession number :
- edsair.doi...........345a66cb15c755d11677d88f7d45a6d9