Analytical performances description of the immunoturbidimetric method for the determination of HbA1c using Selectra Pro M automated system at the Institut National dHygine (INH) of Lom

Abstract

HbA1c is the best indicator for monitoring glycemic control in both type 1 and type 2 diabetic patients. Its value allows us to predict the development of long-term degenerative complications of diabetes. Several techniques offered by different laboratories allow the determination of HbA1c based on different principles. The purpose of the present study was to perform the verification of the analytical performances of the Selectra Pro M automated system, using immunoturbidimetry as the HbA1c assay method. Risk assessment of the method was performed; the analytical performances of the assay process was evaluated and the immunoturbidimetric method on the Selectra Pro M was compared to the capillary method on the Capillarys 2 Flex Piercing. Reproducibility and intermediate precision were satisfactory with CV in the range of 1.78 to 1.96% for the low level of Internal Quality Control (IQC) (HbA1c = 5.4%) and 0.82 to 2.28% for the high level of IQC (HbA1c = 11.3%). The reagent was linear from 2.5 to 16% (4 to 151 mmol/mol). The accuracy was considered satisfactory. The linear regression calculation (least squares line) showed an excellent correlation (R 2 = 0.96) between the two techniques with an equation of the type [Capillarys] = 1.13 [Selectra Pro M] - 0.83. All documented and tested performances correspond to the performance required for HbA1c assay at INH of Lomé.