Original scientific paper

https://doi.org/10.11613/BM.2016.039

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 HbA1c determination

Xiaobin Wu ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Yan Chao ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Zemin Wan ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Yunxiu Wang ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Yan Ma ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Peifeng Ke ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Xinzhong Wu ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Jianhua Xu ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Junhua Zhuang ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China
Xianzhang Huang ; Department of Laboratory Science, Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong, China

Abstract

Introduction: 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.
Materials and 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 HbA1c levels 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 HbA1c concentrations on Roche c501. Elevated HbF induced false HbA1c detection 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 HbA1c methods commonly used with commercial analyzers showed a good reliability and comparability, although some interference may falsely alter the result.

Keywords

Haemoglobin A1c; capillary electrophoresis (CE); high-performance liquid chromatography (HPLC); affinity chromatography; immunoassay

Hrčak ID:

167711

URI

https://hrcak.srce.hr/167711

Publication date:

15.10.2016.

Visits: 2.193 *