One in five laboratories using various hemoglobin A1c methods do not meet the criteria for optimal diabetes care management.

Background: We assessed the reference change value (RCV) of currently available hemoglobin A(1c) (HbA(1c)) laboratory assays, which is defined as the critical difference between two consecutive HbA(1c) measurements representing a significant change in health status.

Methods: We examined the individual laboratory coefficients of variation (CVs) in the Dutch/Belgian quality scheme based on 24 lyophilized samples and calculated the RCV per laboratory (n = 220) and per assay method. In addition, two pooled whole blood samples were sent to the participating laboratories. The individual laboratory results were compared to the assigned value ± an allowable total error (TE(a)) of 6%.

Results: At HbA(1c) values of 41.0 mmol/mol (5.9%-Diabetes Control and Complications Trial [DCCT]) and 61.8 mmol/mol (7.8%-DCCT), 99% and 98%, respectively, of the laboratories reported a value within a TE(a) limit of 6%. The analytical CV of the HbA(1c) method used in 78% of the laboratories is <2.4%. The mean RCV at an HbA(1c) value of 53 mmol/mol (7.0%-DCCT) for methods of Bio-Rad is 5.9 mmol/mol (0.59%-DCCT); for Arkray/Menarini, 4.3 mmol/mol (0.43%-DCCT); for Roche, 6.5 mmol/mol (0.65%-DCCT); for Tosoh, 3.3 mmol/mol (0.33%-DCCT); and for other methods, 6.3 mmol/mol (0.63%-DCCT).

Conclusions: The analytical performance of the majority of laboratory HbA(1c) methods is within the clinical requirements. However, based on the calculated RCV, 21.8% of the laboratories using different HbA(1c) methods are not able to distinguish an HbA(1c) result of 59 mmol/mol (7.5%-DCCT) from a previous HbA(1c) result of 53 mmol/mol (7.0%-DCCT). It can be presumed that differences in HbA(1c) results of 5 mmol/mol (0.5%-DCCT) do influence treatment decisions.