Analysis of Inflammatory Biomarker Changes in Dry Blood Spot Versus Venous Blood Samples

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Venous blood sampling

    Diagnostic test

    -Venous blood samples (1-2 mL) will be collected into EDTA and serum-separator vacutainer tubes. Samples will be processed within one hour by centrifugation (1,500g, 10 min, 4°C), and plasma/serum aliquots will be stored at -80°C

  • Dried blood spot sampling

    Diagnostic test

    -DBS samples will be collected via finger prick (using a lancet) onto certified filter paper (Dried Blood Spot Sample Collection Kit with Lancets, Salimetrics, LLC; State College, PA, USA). Two blood spots (\~20 µL each) will be dried at room temperature for at least two hours, then stored in a sealed bag at -20°C with desiccant. Validated guidelines for the collection, storage and preparation of DBS samples will be followed to ensure proper quality control.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Concordance between inflammatory biomarker concentrations measured in DBS samples and paired venous blood samples

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.

Time frame
Enrollment to 3 days after exposure of stressor

Secondary outcomes

Other outcomes

Sponsors and contacts

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