Comparison of point-of-care HbA1c test versus standardized laboratory testing

Ann Pharmacother. 2005 Jun;39(6):1024-8. doi: 10.1345/aph.1E504. Epub 2005 Apr 19.

Abstract

Background: Glycosylated hemoglobin (HbA1c) evaluation is an accepted standard of care for assessing diabetes control. Point-of-care HbA1c monitors are relatively new, and there are few published data on their accuracy.

Objective: To compare a point-of-care HbA1c monitor with standardized laboratory testing.

Methods: Twenty-three patients who had type 1 or 2 diabetes were identified from our pharmacy-run diabetes clinic at a primary care clinic as needing HbA1c evaluation based on the American Diabetes Association guidelines. All patients with diabetes who attended our clinic were invited to participate in the study. Patients were required to obtain both a standardized laboratory HbA1c evaluation and a point-of-care A1c Now value within a week of each other. An analysis evaluating both clinical and statistical significance was completed at the end of the study.

Results: The A1c Now monitor showed good correlation (r = 0.758) to the standardized laboratory test. We found that the most accurate A1c Now values were within a range of 6-8%. One patient's value would have resulted in a different clinical decision if the decision were based on the A1c Now value.

Conclusions: It appears that A1c Now may provide adequate accuracy and be useful for some patients. The monitor would be most beneficial for patients who cannot obtain standardized laboratory values secondary to either financial or transportation constraints. However, the decision to make adjustments in therapy should not be based solely on the A1c Now point-of-care result.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Blood Glucose Self-Monitoring / instrumentation
  • Blood Glucose Self-Monitoring / methods
  • Clinical Laboratory Techniques / methods
  • Clinical Laboratory Techniques / standards*
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / diagnosis
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / diagnosis
  • Glycated Hemoglobin A / analysis*
  • Glycated Hemoglobin A / standards
  • Humans
  • Point-of-Care Systems / standards*
  • Reproducibility of Results

Substances

  • Glycated Hemoglobin A