Department of Clinical Laboratory, Yokkaichi Social Insurance Hospital, Yokkaichi, Japan.
Ann Clin Biochem. 2013 Sep;50(Pt 5):443-9. doi: 10.1177/0004563213476859. Epub 2013 Jul 29.
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.
已经开发出用于糖化血红蛋白（HbA1c）测量的酶法测定法，这些方法可以在通用的自动临床分析仪上运行。使用具有内置溶血系统的 Bio Majesty（BM）6010/C 评估了酶法 HbA1c 测定法 BM Test HbA1c 的性能。
我们评估了从离心红细胞层采集的样本位置的差异是否会导致 BM6010/C 和 Tosoh G7 获得的 HbA1c 值不同。评估了 BM Test HbA1c 的性能。
配对 t 检验的结果表明，当样品探针尖端位置在 1mm、3mm 或 5mm 时，与 Tosoh G7 的 HbA1c 值之间没有显著差异。批内和批间精密度的变异系数（CV）均约为 1.0%。用 BM Test HbA1c 和 Tosoh G7 分析 351 例常规实验室样本得到的相关系数为 0.994。线性上限验证至 17.0（NGSP%）。未观察到血红蛋白化学修饰衍生物的干扰。血红蛋白变异体的存在不会导致 BM Test HbA1c 和 Primus 高效液相色谱（HPLC）之间的结果产生统计学上的显著差异。使用国际临床化学和实验室医学联合会（IFCC）HbA1C 控制品进行的准确性评估，其相对误差（%）在给定值的 3.4%范围内。
上述结果证明，具有内置溶血系统的 BM6010/C 上分析的测量系统 BM Test HbA1c 可有效用于实验室常规检测。
