Jinming Xing1, Joseph Loureiro2, Michael T Patel1,3, Dmitri Mikhailov1, Arkady I Gusev1. 1. Biomarker Development, Novartis Institutes for BioMedical Research, 220 Massachusetts Ave, Cambridge, MA 02139, USA. 2. Chemical Biology & Therapeutics, Novartis Institutes for BioMedical Research, 250 Massachusetts Ave, Cambridge, MA 02139, USA. 3. Biopharmaceutical Industry Fellowship Program, Massachusetts College of Pharmacy & Health Sciences University, 179 Longwood Ave, Boston, MA 02115, USA.
Abstract
Aim: Evaluation of a novel microsampling device for its use in clinical sample collection and biomarker analysis. Methodology: Matching samples were collected from 16 healthy donors (ten females, six males; age 42 ± 20) via K2EDTA touch activated phlebotomy (TAP) device and phlebotomy. The protein profile differences between sampling groups was evaluated using aptamer-based proteomic assay SomaScan and selected ELISA. Conclusion: Somascan signal concordance between phlebotomy- and TAP-generated samples was studied and comparability of protein abundances between these blood sample collection methods was demonstrated. Statistically significant correlation in selected ELISA assays also confirmed the TAP device applicability to the quantitative analysis of protein biomarkers in clinical trials.
Aim: Evaluation of a novel microsampling device for its use in clinical sample collection and biomarker analysis. Methodology: Matching samples were collected from 16 healthy donors (ten females, six males; age 42 ± 20) via K2EDTA touch activated phlebotomy (TAP) device and phlebotomy. The protein profile differences between sampling groups was evaluated using aptamer-based proteomic assay SomaScan and selected ELISA. Conclusion: Somascan signal concordance between phlebotomy- and TAP-generated samples was studied and comparability of protein abundances between these blood sample collection methods was demonstrated. Statistically significant correlation in selected ELISA assays also confirmed the TAP device applicability to the quantitative analysis of protein biomarkers in clinical trials.
Authors: Joshua Zarbl; Ekaterina Eimer; Camilla Gigg; Gerlinde Bendzuck; Marianne Korinth; Corinna Elling-Audersch; Arnd Kleyer; David Simon; Sebastian Boeltz; Martin Krusche; Johanna Mucke; Felix Muehlensiepen; Nicolas Vuillerme; Gerhard Krönke; Georg Schett; Johannes Knitza Journal: RMD Open Date: 2022-09