Accuracy of Three Commercial Home-Use Hemoglobin A1c Tests

Laura M. Jacobsen, 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, Roy W. Beck

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Background: The COVID-19 pandemic and the rapid expansion of telemedicine have increased the need for accurate and reliable capillary hemoglobin A1c (HbA1c) testing. Nevertheless, validation studies of commercially available products suitable for home use have been in short supply. Methods: Three commercial home-use capillary blood sample HbA1c tests (Home Access, CoreMedica, and A1cNow+) were evaluated in 219 participants with type 1 or type 2 diabetes (4-80 years years of age, HbA1c 5.1%-13.4% [32-123 mmol/mol]) at four clinical sites. Comparisons were made between HbA1c measurements from the commercial tests and paired venous samples for which HbA1c was measured at two central reference laboratories. The primary outcome was percentage of commercial HbA1c values within 5% of the corresponding reference values. Results: HbA1c values were within 5% (relative difference) of paired reference values for 82% of Home Access samples, 29% of CoreMedica samples, and 46% of A1cNow+ samples. Absolute differences were within 0.3% of the reference value for 75% of Home Access samples, 28% of CoreMedica samples, and 44% of A1cNow+ samples and exceeded 0.5% for 8%, 55%, and 37%, respectively. Conclusions: None of the commercial home-use HbA1c tests produced the National Glycohemoglobin Standardization Program goal of ≥90% measurements within 5% of a DCCT venous reference. However, the Home Access product performed substantially better than the CoreMedica or A1cNow+ products. Telemedicine is likely to persist as a mainstay of diabetes care well after the COVID-19 era. As such, accurate home-based HbA1c assessment represents an urgent need for the diabetes community.

Original languageEnglish (US)
Pages (from-to)789-796
Number of pages8
JournalDiabetes Technology and Therapeutics
Volume24
Issue number11
DOIs
StatePublished - Nov 2022

Bibliographical note

Publisher Copyright:
© Copyright 2022, Mary Ann Liebert, Inc., publishers 2022.

Keywords

  • Accuracy
  • Commercial
  • HbA1c
  • Home use
  • Type 1 diabetes
  • Type 2 diabetes

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