6.2.2 Quality Specifications for Glycated Hemoglobin A1c

Abstract

Berne (1) has suggested that a change in the measured value (in per cent) of GHbAlc that is smaller than 1.0% does not lead to any therapeutic action from the clinician. Since the meeting of the “Friibergh HerrgHrd Seminar”, April 23–24, 1990 on the “Medical Need for Quality Specifications in Laboratory Medicine” (9) we have discussed this with our specialists at the Kuopio University Hospital and they share Berne's opinion. Keeping this in mind we have standardized our method so that the total analytical variation of the GHbAlc is small as compared to the measured biological variation of GHbAlc in nondiabetic and diabetic subjects. In this report we describe how we have succeeded in keeping the coefficient of variation of our routine method for GHbAlc analyses small enough for clinical purposes.