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Validation of biomarkers of CVD risk from dried blood spots in community-based research: Methodologies and study-specific serum equivalencies
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Details:
  • Pubmed ID:
    26652683
  • Pubmed Central ID:
    PMC4812568
  • Funding:
    R01 HL104607/HL/NHLBI NIH HHS/United States
    R01 HL107240/HL/NHLBI NIH HHS/United States
    R01-HL104607/HL/NHLBI NIH HHS/United States
    R01-HL107240/HL/NHLBI NIH HHS/United States
    T32 HL007901/HL/NHLBI NIH HHS/United States
    T32-HL007901/HL/NHLBI NIH HHS/United States
    U01 AG027669/AG/NIA NIH HHS/United States
    U01-AG027669/AG/NIA NIH HHS/United States
    U19 OH008861/OH/NIOSH CDC HHS/United States
    U19 OH008861/OH/NIOSH CDC HHS/United States
    UL1 RR024153/RR/NCRR NIH HHS/United States
    UL1 RR025758/RR/NCRR NIH HHS/United States
    UL1 TR000005/TR/NCATS NIH HHS/United States
    UL1-RR024153/RR/NCRR NIH HHS/United States
    UL1-TR000005/TR/NCATS NIH HHS/United States
  • Document Type:
  • Collection(s):
  • Description:
    Objective

    Dried blood spot (DBS) methodology offers significant advantages over venipuncture in vulnerable populations or large-scale studies, including reduced participant burden and higher response rates. Uncertainty about validity of cardiovascular risk biomarkers remains a barrier to wide-scale use. We determined the validity of DBS-derived biomarkers of CVD risk versus gold-standard assessments, and study-specific, serum-equivalency values for clinical relevance of DBS-derived values.

    Methods

    Concurrent venipuncture serum and DBS samples (n=150 adults) were assayed in CLIA-certified and DBS laboratories, respectively. Time controls of DBS standard samples were assayed single-blind along with test samples. Linear regression analyses evaluated DBS-to-serum equivalency values; agreement and bias were assessed via Bland-Altman plots.

    Results

    Linear regressions of venipuncture values on DBS-to-serum equivalencies provided R2 values for TC, HDL-C, CRP of 0.484, 0.118, 0.666, respectively. Bland-Altman plots revealed minimal systematic bias between DBS-to-serum and venipuncture values; precision worsened at higher mean values of CRP. Time controls reveal little degradation or change in analyte values for HDL-C and CRP over 30 weeks.

    Conclusions

    DBS-assessed biomarkers represent a valid alternative to venipuncture assessments. Large studies using DBS should include study-specific serum-equivalency determinations to optimize individual-level sensitivity, viability of detecting intervention effects, and generalizability in community-level, primary prevention interventions.