Analysis of Inflammatory Biomarker Changes in Dry Blood Spot Versus Venous Blood Samples (DBS-VB)

March 23, 2026 updated by: Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre

The purpose of this study is to see whether dried blood spot (DBS) samples can measure inflammatory biomarkers as accurately as venous blood samples.

Investigators will be measuring inflammatory biomarkers changes obtained in DBS compared with paired venous blood samples following a controlled physiological stressor (i.e. after a vaccine or other planned event that can cause a temporary rise in inflammation).

These findings will help understand whether DBS can be a reliable alternative to traditional blood draws in future research and healthcare.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Inflammation plays a key role in the progression of both acute and chronic health conditions. When properly regulated, inflammatory responses enable the body to adapt to short-term stressors such as infection, vaccination, or strenuous exercise.1 In contrast, excessive and/or prolonged inflammation can lead to the development and progression of chronic health conditions including cardiovascular disease, autoimmune disorders, and metabolic dysfunction.2 In both acute and chronic settings, measuring changes in inflammatory biomarkers allows us to better understand how the immune system responds to physiological challenges, which may ultimately support the development of earlier testing (diagnostic) strategies, more accurate detection methods, and timely interventions for individuals most at risk.

Venous blood sampling is the gold standard for measuring inflammatory biomarker concentrations. However, venous blood sampling is invasive, requires trained personnel, and entails a visit to a hospital or health clinic.3 Dependence on venous sampling for inflammatory biomarker detection therefore limits the feasibility of decentralized, real-world investigations, such as those conducted in home environments. This restriction reduces opportunities for longitudinal data collection and poses challenges for larger-scale and/or high temporal frequency sampling protocols.

More recently, dried blood spot (DBS) samples have shown to be a compelling alternative to assess inflammatory biomarkers like C-reactive protein (CRP) in the blood. In comparison, this method is minimally invasive, can be obtained by the patient rather than trained personnel, involves fewer requirements for transport and storage, and is less costly than venous blood sampling.3-7 Previous comparative studies between venous blood sampling and DBS, have shown the latter's potential for measuring a wide range of indices, including inflammatory biomarkers during both chronic and acute medical conditions. In fact, numerous studies have shown good concordance between the DBS and venous blood sampling methods, namely for CRP, interleukin (IL)-6, IL-10, and tumor necrosis factor alpha (TNF-α).3,8-13 Furthermore, a recent study by Anderson et al. demonstrated that DBS can reliably capture dynamic changes in 12 inflammatory biomarkers (incl., serum amyloid A (SAA), myeloperoxidase (MPO), immunoglobin M (IgM)) across diverse conditions (infection, vaccination, surgery, exercise, Crohn's disease) and over both acute and chronic timescales; however, these markers have yet to be directly compared to venous blood sample analysis.14 It is not yet well enough established whether inflammatory biomarkers can be measured from DBS with the same quality, sensitivity, and reproducibility as from venous blood samples, while certain gaps remain regarding how DBS performs when capturing acute, stressor-induced fluctuations in circulation concentrations of inflammatory biomarkers. Addressing these gaps is critical to determine whether DBS can serve as a valid substitute for venous blood sampling in research and clinical contexts. Based on these considerations, this study aims to validate the measurement of change in inflammatory biomarkers obtained in DBS compared with paired venous blood samples following a controlled physiological stressor, using a comprehensive (48-plex) inflammatory biomarker panel.

The overarching aim of this study is to validate and compare the measurement of changes in inflammatory biomarkers obtained from dried blood spot (DBS) samples against paired venous blood samples, using the Human Cytokine/Chemokine Panel A 48-Plex (HD48A).

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Evelyn Laferrière, BSc.
  • Phone Number: 23730 514-934-1934
  • Email: cpau.med@mcgill.ca

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 0B1
        • Recruiting
        • Research Institute of the McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Emily G. McDonald, MD MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult participants who are planning to receive a seasonal vaccine OR have a scheduled acute stressor

Description

Inclusion Criteria:

  • Men or women aged ≥18 years, who are planning to receive a seasonal vaccine OR have a scheduled acute stressor*.

Exclusion Criteria:

  • Any infectious symptoms (fever, cough, rhinorrhea, sore throat, diarrhea, loss of smell or taste) within the previous 7 days
  • Any self-reported active/recent use of cocaine, injection drugs, or amphetamines
  • Acute worsening of a known chronic health condition within the previous 30 days (e.g., of IBD, COPD, asthma, rheumatologic disease)
  • Known severe allergy or intolerance to the planned vaccine

  • Contraindication to the vaccine received, if applicable

    *List of possible scheduled acute stressors include:

  • Hard exercise (incl. 10km run or longer, high-intensity interval training, or comparable endurance activity)
  • Social event with moderate alcohol consumption
  • Planned change in medication dose and/or frequency of use
  • Onset of menstruation (day 1)
  • Other pre-planned stressors expected to elicit an inflammatory response

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance between inflammatory biomarker concentrations measured in DBS samples and paired venous blood samples
Time Frame: Enrollment to 3 days after exposure of stressor

Agreement and variability between both sample types will be measured using multiple approaches:

  • coefficients of variation
  • intraclass correlation coefficients (ICC)
  • Pearson correlation coefficients
  • Bland-Altman analyses.
Enrollment to 3 days after exposure of stressor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Sensifai Health

Investigators

  • Principal Investigator: Emily G. McDonald, MD MSc, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-11986

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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