Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis

Author:

Xing Jinming1ORCID,Loureiro Joseph2ORCID,Patel Michael T13,Mikhailov Dmitri1,Gusev Arkady I1

Affiliation:

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

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