Validation of Biomarkers of CVD Risk from Dried Blood Spots in Community-Based Research: Methodologies and Study-Specific Serum Equivalencies

Abstract

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.

Biomarkers, disability and health care demand

“…Our results highlight the importance of widening the range of health indicators considered by public health screening programs. This is increasingly feasible using dried blood spot sampling (drops of whole blood collected on filter paper from a finger prick), which offers a minimally invasive basis for carrying out a wide range of blood tests at low cost (Martial, 2016;Samuelsson, 2015).…”

Work–family conflict, cardiometabolic risk, and sleep duration in nursing employees.

“…Body mass index (height/weight 2 ) was calculated based on height (Seca213/214 stadiometers, Seca North America, Hanover, MD) and weight (Health-O-Meter 800KL, Jarden Corporation, Rye, NY) assessment. Up to five blood spots were collected on bar-coded filter paper (903 Protein Saver Paper, GE Healthcare Bio-Sciences Corp., Piscataway, NJ) as previously described (Ostler, Porter, & Buxton, 2014), air-dried, and sealed in a plastic bag for room-temperature shipment with desiccant for storage at −86°C until assay for cholesterol as specifically validated for this study from serum to DBS equivalents (Samuelsson et al, Under Review). Interviewers also collected a 1 microliter blood droplet for immediate measurement of HbA1c levels (DCA Vantage Analyzer, Siemens Healthcare Diagnostics, Frimley, Camberley, UK).…”

Dried blood spots: Effects of less than optimal collection, shipping time, heat, and humidity

“…This minimally invasive blood collection method is relatively simple compared to conventional blood sampling as it can be done by interviewers rather than medically trained personnel (Amsterdam & Waldrop, 2010;Deep, Kumar, Kumar, & Thakkar, 2012). DBS samples may also be easier to obtain as respondents are more likely to agree to participate (Samuelsson et al, 2015;Williams & McDade, 2009). Additional desirable features of this type of blood collection include minimal requirements for transport and storage (e.g., ambient temperature, no dry ice required, no hazardous material regulations in shipping), and reduced biohazard risks and contamination (Kulmatycki, Xu, & Jarugula, 2014;Mei & Lee, 2014;Parker & Cubitt, 1999;Zhang, Majumdar, Flarakos, & Tse, 2013).…”