An Evaluation of Two Capillary Sample Collection Kits for Laboratory Measurement of HbA1c

Roy W. Beck, Laura E. Bocchino, John W. Lum, Craig Kollman, Victoria Barnes-Lomen, Mark Sulik, Michael J. Haller, Bruce Bode, Joseph T. Cernich, Anthony A. Killeen, Uttam Garg, David Liljenquist, Janey G. Adams, Margaret Clements, Deanna Gabrielson, Terri Johnson, Mark A. Clements

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The COVID-19 pandemic has impacted the conduct of clinic visits. We conducted a study to evaluate two academic laboratories' fingerstick capillary blood collection kits suitable for home use for laboratory measurement of HbA1c. Methods: Four clinical sites recruited 240 participants (aged 4-80 years, HbA1c 5.1%-13.5%). Capillary blood samples were obtained by the participant or parent using collection kits from two laboratories (University of Minnesota Advanced Research and Diagnostic Laboratory (ARDL) and Children's Mercy Hospital Laboratory (CMH)) and mailed under varying shipping conditions by United States Postal Service to the laboratories. Comparisons were made between HbA1c measurements from capillary samples and contemporaneously obtained venous samples. The primary outcome was percentage of capillary HbA1c values within 5% of the corresponding venous values. Results: HbA1c values were within 5% of venous values for 96% of ARDL kit specimens shipped with a cold pack and 98% without a cold pack and 99% and 99%, respectively, for the CMH kits. R2 values were 0.98, 0.99, 0.99, and 0.99, respectively. Results appeared similar across HbA1c levels and for pediatric and adult participants. Usability survey scores were high. Conclusions: Capillary blood collection kits, suitable for home use, from two academic laboratories, were demonstrated to be easy to use and provided results that are comparable with those obtained from venous specimens. Based on these results, there is strong evidence that HbA1c measurements from capillary specimens obtained with these specific kits can be used interchangeably with HbA1c measurements from venous specimens for clinical research and clinical care.

Original languageEnglish (US)
Pages (from-to)537-545
Number of pages9
JournalDiabetes Technology and Therapeutics
Volume23
Issue number8
DOIs
StatePublished - Aug 1 2021

Bibliographical note

Funding Information:
Funding for the study was provided by the Leona M. and Harry B. Helmsley Charitable Trust.

Publisher Copyright:
© 2021, Mary Ann Liebert, Inc., publishers.

Keywords

  • Accuracy
  • adults
  • children
  • HbA1c measurement
  • Home A1c testing
  • Type 1 diabetes
  • Type 2 diabetes

PubMed: MeSH publication types

  • Evaluation Study
  • Journal Article

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