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Related Experiment Video

Updated: Jul 12, 2025

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
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Decentralized clinical trial design using blood microsampling technology for serum bioanalysis.

Dana Lee1, Charles G Rapp V2, Joseph Loureiro3

  • 1Biomarker Development, Novartis Institutes for BioMedical Research, 220 Massachusetts Ave., Cambridge, MA 02139, USA.

Bioanalysis
|October 19, 2023
PubMed
Summary

Serum microsampling devices offer a less burdensome alternative to traditional blood draws in clinical trials. Proper centrifugation timing is crucial for preserving biomarker stability and ensuring reliable test results.

Keywords:
SomaScanTAP®biomarkersclinical trial operationsmicrosamplingpatient-centric samplingproteomicsremote collectionsampling device

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Area of Science:

  • Biomedical Engineering
  • Clinical Chemistry
  • Proteomics

Background:

  • Phlebotomy alternatives enhance clinical trial accessibility and patient convenience.
  • Investigating technical and logistical aspects of microsampling technology versus conventional phlebotomy.

Purpose of the Study:

  • To evaluate a serum gel microsampling device against traditional phlebotomy.
  • To assess the impact of sample handling on microsample quality for clinical testing and proteomic analysis.

Main Methods:

  • Paired blood samples collected from 16 donors using a second-generation serum gel microsampling device and standard phlebotomy.
  • Microsamples subjected to varied handling conditions and analyzed for quality, clinical assays, and proteome profiling.

Main Results:

  • Timely centrifugation of serum microsamples demonstrated preservation of analyte stability.
  • Specific clinical chemistry and protein biomarkers were affected by centrifugation timing.

Conclusions:

  • Centrifugation timing is a critical factor for serum microsample integrity.
  • Microsampling devices with remote centrifugation and cold chain logistics can reduce patient burden and broaden trial participation.