Analysis of point-of-care and over-the-counter testing methods for hemoglobin A1c: how good do they need to be?
In this issue of Journal of Diabetes Science and Technology, Chang and colleagues evaluate the performance of the A1CNow® SELFCHECK device for measurement of hemoglobin A1c (HbA1c). The authors discuss the potential advantages of point-of-care (POC) HbA1c testing and also mention the importance of accuracy and precision and provide some data to document the device's performance. There are specific criteria for HbA1c method evaluation and proficiency testing used by the National Glycohemoglobin Standardization Program and the College of American Pathologists. Chang and colleagues mention these criteria but chose wider performance limits for their evaluation of the A1cNow SELFCHECK. Given the available data on the relationship between HbA1c and risk for complications, assay method performance is a vital consideration when HbA1c results, including those from POC methods, are used in the management of patients with diabetes.
Department of Pathology & Anatomical Sciences, University of Missouri-Columbia School of Medicine, Columbia, Missouri 65212, USA. littler@health.missouri.edu
Randie R
RR
Little
D015415:Biomarkers / Q000097:blood; D001800:Blood Specimen Collection; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis*; D004867:Equipment Design; D006442:Glycated Hemoglobin / Q000032:analysis*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D010353:Patient Education as Topic; D017060:Patient Satisfaction; D019095:Point-of-Care Systems / Q000592:standards; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic / Q000592:standards; D015203:Reproducibility of Results
D015415:Biomarkers; D006442:Glycated Hemoglobin; D011933:Reagent Kits, Diagnostic; C517652:hemoglobin A1c protein, human