Evaluation of haemoglobin A1c measurement by an enzymatic method using an automated analyser that has an on-board haemolysis system

Abstract

Enzymatic assays, which can be run on a general automated clinical analyser, have been developed for haemoglobin A1c (HbA1c) measurement. The performance of the BM Test HbA1c which is an enzymatic HbA1c assay was evaluated using the Bio Majesty (BM)6010/C, which has an on-board haemolysis system. We evaluated whether the difference in sampling position from the centrifuged erythrocyte layer caused a difference in HbA1c values obtained by the BM6010/C and the Tosoh G7. The performance of the BM Test HbA1c was evaluated. The results of the paired t-test showed no significant difference between the values of HbA1c when the tip positions of the sample probe were at 1 mm, 3 mm or 5 mm and the values given by the Tosoh G7. The coefficient of variation (CV) of intra-assay and inter-assay precision were both approximately 1.0%. The correlation coefficient obtained from an analysis of 351 routine laboratory samples with the BM Test HbA1c and the Tosoh G7 was 0.994. The upper limit of linearity was verified up to 17.0 (NGSP%). No interference was observed from chemically modified derivatives of haemoglobin. The presence of haemoglobin variants produced no statistically significant differences in the results between the BM Test HbA1c and the Primus high-performance liquid chromatography (HPLC). Accuracy evaluation using an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) HbA1C control was within 3.4% relative error (%) of the assigned value. The above outcomes prove that the measurement system, the BM Test HbA1c analysed on the BM6010/C, which has an on-board haemolysis system, is effective in laboratory routine tests.