Assessing the use of a micro-sampling device for measuring blood protein levels in healthy subjects and COVID-19 patients

• Published in: PloS one Vol. 17; no. 8; p. e0272572
• Main Authors: Brandsma, Joost, Chenoweth, Josh G., Gregory, Melissa K., Krishnan, Subramaniam, Blair, Paul W., Striegel, Deborah A., Mehta, Rittal, Schully, Kevin L., Dumler, J. Stephen, Sikorski, CDR Cynthia S., O’Connor, Kelsey, Reichert-Scrivner, Susan A., Paguirigan, Carmen M., Uyehara, Catherine F. T., Ngauy, COL Viseth, Myers, Christopher A., Clark, Danielle V.
• Format: Journal Article
• Language: English
• Published: San Francisco Public Library of Science 10.08.2022; Public Library of Science (PLoS)
• Subjects: Analysis; Analytical chemistry; Armed forces; Biological markers; Biology and Life Sciences; Biomarkers; Blood; Blood levels; Blood proteins; Capillary tubes; Chronic infection; Clinical trials; Collection; Consent; Coronaviruses; COVID-19; Ferritin; Health care facilities; Health facilities; IL-1β; Inflammation; Interleukin 1; Interleukin 1 receptor antagonist; Interleukin 1 receptors; Interleukin 6; Measuring instruments; Medical research; Medicine and Health Sciences; Military facilities; Military health care; Patients; Phlebotomy; Plasma; Proteins; Reproducibility; Samplers; Sampling; Separators; Serum proteins; Severe acute respiratory syndrome coronavirus 2; Telemedicine; Temperature control; Viral diseases; United States; United States > US
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0272572

Background Venous phlebotomy performed by trained personnel is critical for patient diagnosis and monitoring of chronic disease, but has limitations in resource-constrained settings, and represents an infection control challenge during outbreaks. Self-collection devices have the potential to shift phlebotomy closer to the point of care, supporting telemedicine strategies and virtual clinical trials. Here we assess a capillary blood micro-sampling device, the Tasso Serum Separator Tube (SST), for measuring blood protein levels in healthy subjects and non-hospitalized COVID-19 patients. Methods 57 healthy controls and 56 participants with mild/moderate COVID-19 were recruited at two U.S. military healthcare facilities. Healthy controls donated Tasso SST capillary serum, venous plasma and venous serum samples at multiple time points, while COVID-19 patients donated a single Tasso SST serum sample at enrolment. Concentrations of 17 protein inflammatory biomarkers were measured in all biospecimens by Ella multi-analyte immune-assay. Results Tasso SST serum protein measurements in healthy control subjects were highly reproducible, but their agreements with matched venous samples varied. Most of the selected proteins, including CRP, Ferritin, IL-6 and PCT, were well-correlated between Tasso SST and venous serum with little sample type bias, but concentrations of D-dimer, IL-1B and IL-1Ra were not. Self-collection at home with delayed sample processing was associated with significant concentrations differences for several analytes compared to supervised, in-clinic collection with rapid processing. Finally, Tasso SST serum protein concentrations were significantly elevated in in non-hospitalized COVID-19 patients compared with healthy controls. Conclusions Self-collection of capillary blood with micro-sampling devices provides an attractive alternative to routine phlebotomy. However, concentrations of certain analytes may differ significantly from those in venous samples, and factors including user proficiency, temperature control and time lags between specimen collection and processing need to be considered for their effect on sample quality and reproducibility.