Ucar Fatma, Erden Gonul, Ozdemir Seyda, Yildiz Zeynep, Arzuhal Abdullah Ercan, Temel Ismail
Clin Lab. 2016;62(3):443-9. doi: 10.7754/clin.lab.2015.150742.
The aim of our study was to assess the analytical performance of the Tosoh HLC-723G8 automated analyzer and to compare it with the Trinity Biotech Premier Hb9210 analyzer for the measurement of hemoglobin A₁c (HbA₁c).
A total of 101 patients with pre-diabetes or diabetes mellitus were included in the study. HbA₁c, was measured by both an ion-exchange high-performance liquid chromatography (IE-HPLC) method and a boronate affinity chromatography method. Statistical analysis was performed using Deming regression. Bland-Altman plots were used to calculate mean difference (bias).
The CV% values of IE-HPLC and boronate affinity methods for within run and between days were lower than 2.0%. High correlation was found (y = 1.0045x + 0.2111; r = 0.9941) between the two methods. The method shows no interference from carbamylated hemoglobin.
Both systems showed acceptable performance and are suitable for clinical application in the analysis of HbA₁c. However, laboratories should be aware of the limitations of their methods and the availability of more accurate and precise HbA₁c, determination methods.
我们研究的目的是评估托索HLC - 723G8自动分析仪的分析性能，并将其与Trinity Biotech Premier Hb9210分析仪用于测量糖化血红蛋白（HbA₁c）的性能进行比较。
共有101例糖尿病前期或糖尿病患者纳入本研究。HbA₁c采用离子交换高效液相色谱法（IE - HPLC）和硼酸亲和色谱法进行测量。使用Deming回归进行统计分析。采用Bland - Altman图计算平均差异（偏差）。
IE - HPLC法和硼酸亲和法批内和批间的CV%值均低于2.0%。两种方法之间具有高度相关性（y = 1.0045x + 0.2111；r = 0.9941）。该方法未显示出受氨甲酰化血红蛋白的干扰。
两种系统均表现出可接受的性能，适用于HbA₁c分析的临床应用。然而，实验室应意识到其方法的局限性以及更准确和精密的HbA₁c测定方法的可用性。
