Evaluation of an over-the-counter glycated hemoglobin (A1C) test kit

J Diabetes Sci Technol. 2010 Nov 1;4(6):1495-503. doi: 10.1177/193229681000400625.

Abstract

Background: Glycated hemoglobin (A1C) monitoring is an integral component of diabetes management. This study was conducted to evaluate the performance of the A1CNow® SELFCHECK device when used by lay users and health care professionals (HCPs) to measure A1C.

Methods: Subjects performed two A1CNow SELFCHECK finger-stick self-tests followed by a finger-stick test of the subject's blood by a HCP. The primary endpoint assessed accuracy of the subject and HCP A1CNow SELFCHECK readings. Secondary endpoints included precision, comprehension of instructional material (written material±DVD), and product satisfaction. For accuracy comparison, a venous blood sample was drawn from each subject and tested by laboratory (TOSOH) analysis. Subject comprehension of product instructional material was evaluated via first-time failure (FTF) rate as recorded by the HCP, and subject satisfaction was assessed through written survey.

Results: A total of 110 subjects with (n=93) and without (n=17) diabetes participated. Of 177 subject A1C values, 165 (93.2%) were within the acceptable range of ±13.5% of the laboratory reference value and considered accurate. Regression analysis showed good correlation of subject values to laboratory and HCP results (R2=0.93 for both). The average within-subject coefficient of variation was 4.57% (n=74). The FTF rates with and without instructional DVD were 11.3% (n=56) and 39.6% (n=54), respectively. Subjects with diabetes/prediabetes overwhelmingly indicated that they were "very" to "extremely" likely (93.5%) to discuss their home A1C results with their HCP.

Conclusions: Lay users found the A1CNow SELFCHECK easy to use, and both lay users and HCPs were able to measure A1C accurately.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Biomarkers / blood
  • Blood Specimen Collection
  • Comprehension
  • Diabetes Mellitus, Type 1 / blood
  • Diabetes Mellitus, Type 1 / diagnosis*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / diagnosis*
  • Equipment Design
  • Female
  • Glycated Hemoglobin A / analysis*
  • Health Knowledge, Attitudes, Practice
  • Humans
  • Male
  • Middle Aged
  • Patient Education as Topic
  • Patient Satisfaction
  • Point-of-Care Systems*
  • Prediabetic State / blood
  • Prediabetic State / diagnosis*
  • Predictive Value of Tests
  • Reagent Kits, Diagnostic*
  • Reproducibility of Results
  • Surveys and Questionnaires
  • United States
  • Young Adult

Substances

  • Biomarkers
  • Glycated Hemoglobin A
  • Reagent Kits, Diagnostic
  • hemoglobin A1c protein, human