A comparative evaluation of the analytical performances of Capillarys 2 Flex Piercing, Tosoh HLC-723 G8, Premier Hb9210, and Roche Cobas c501 Tina-quant Gen 2 analyzers for HbA1cdetermination.
BACKGROUND
Haemoglobin A1c(HbA1c) is widely used in the management of diabetes. Therefore, the reliability and comparability among different analytical methods for its detection have become very important.


METHODS
A comparative evaluation of the analytical performances (precision, linearity, accuracy, method comparison, and interferences including bilirubin, triglyceride, cholesterol, labile HbA1c(LA1c), vitamin C, aspirin, fetal haemoglobin (HbF), and haemoglobin E (Hb E)) were performed on Capillarys 2 Flex Piercing (Capillarys 2FP) (Sebia, France), Tosoh HLC-723 G8 (Tosoh G8) (Tosoh, Japan), Premier Hb9210 (Trinity Biotech, Ireland) and Roche Cobas c501 (Roche c501) (Roche Diagnostics, Germany).


RESULTS
A good precision was shown at both low and high HbA1clevels on all four systems, with all individual CVs below 2% (IFCC units) or 1.5% (NGSP units). Linearity analysis for each analyzer had achieved a good correlation coefficient (R2> 0.99) over the entire range tested. The analytical bias of the four systems against the IFCC targets was less than ± 6% (NGSP units), indicating a good accuracy. Method comparison showed a great correlation and agreement between methods. Very high levels of triglycerides and cholesterol (≥ 15.28 and ≥ 8.72 mmol/L, respectively) led to falsely low HbA1cconcentrations on Roche c501. Elevated HbF induced false HbA1cdetection on Capillarys 2FP (> 10%), Tosoh G8 (> 30%), Premier Hb9210 (> 15%), and Roche c501 (> 5%). On Tosoh G8, HbE induced an extra peak on chromatogram, and significantly lower results were reported.


CONCLUSIONS
The four HbA1cmethods commonly used with commercial analyzers showed a good reliability and comparability, although some interference may falsely alter the result.
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Xiaobin
X
Wu
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Yan
Y
Chao
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Zemin
Z
Wan
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Yunxiu
Y
Wang
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Yan
Y
Ma
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Peifeng
P
Ke
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Xinzhong
X
Wu
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Jianhua
J
Xu
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Junhua
J
Zhuang
Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China.
Xianzhang
X
Huang
D016477:Artifacts; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation*; D019075:Electrophoresis, Capillary / Q000295:instrumentation*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D057230:Limit of Detection; D015203:Reproducibility of Results
D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
Haemoglobin A1c; affinity chromatography; capillary electrophoresis (CE); high-performance liquid chromatography (HPLC); immunoassay