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.

Is There a Relationship between Mean Blood Glucose and Glycated Hemoglobin?

“…115,116 Clinical laboratories use methods and analyzers that are traceable to this reference, although many diabetes centers and private practice physicians rely on point-of-care instruments to measure HbA1c, with some of them not showing acceptable analytical performance. 117,118 The second problem is the calculation of MBG from patient self-monitoring. This can be achieved today either by portable meters or CGM or combination of the two.…”

Pitfalls in Hemoglobin A1c Measurement: When Results may be Misleading

“…Advantages of POC testing include fingerstick sampling in the provider's office and immediate patient and provider feedback leading to timely adjustments in the treatment regimen. Though use of POC assays has been shown to improve A1c outcomes, 12 there is a lack of evidence from randomized clinical trials. 13 Furthermore, several different POC assays are available and have variable accuracy and precision when compared to NGSP certification criteria.…”

Glycated Serum Albumin and AGE Receptors

“…These include HPLC [309,310], enzymatic assays [311], capillary electrophoresis [312], and immunoassays [313,314]. Over the counter, direct to consumer home tests and point-of-care testing for HbA1c has become available as well [315,316].…”