Evaluation of an Over-the-Counter Glycated Hemoglobin (A1C) Test Kit

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.