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

Abstract

IntroductionHaemoglobin 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 methodsA 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).ResultsA 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.ConclusionsThe four HbA1c methods commonly used with commercial analyzers showed a good reliability and comparability, although some interference may falsely alter the result.

Measurement of HbA1c and HbA2 by Capillarys 2 Flex Piercing HbA1c programme for simultaneous management of diabetes and screening for thalassemia

“…The β-thalassemia is characterized by variable increases in HbF and unusually high HbA 2 concentrations. Our previous study found that an increased proportion of HbF could affect the HbA 1c results using Capillarys 2FP ( 5 ). Thus, the β-thalassemia intermedia/major sample with highly elevated HbF (> 10%) could interfere the HbA 1c measurement by Capillarys 2FP.…”

“…Our previous study indicated that HbA 1c concentrations measured by Capillarys 2FP system in normal samples, without haemoglobinopathies, showed high correlation and concordance with those obtained using a boronate affinity high-performance liquid chromatography (HPLC) system, i.e. Premier Hb9210 (Trinity Biotech Plc, Bray, Ireland) ( 5 ). Further accuracy verification demonstrated a great consistency with International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method (HPLC/CE) values ( 5 ).…”

“…HbA 1c concentrations are used as an index for long-term glycaemic control, and have recently been recommended for the diagnosis of diabetes mellitus ( 2 - 4 ). Various methods have been developed to measure HbA 1c , however, their accuracy can be adversely affected by the presence of haemoglobinopathies ( 5 , 6 ). In addition, HbA 1c provides an estimate of blood glucose concentrations over a normal erythrocyte lifespan, and any conditions altering erythrocyte survival ( e.g.…”

“…Premier Hb9210 (Trinity Biotech Plc, Bray, Ireland) ( 5 ). Further accuracy verification demonstrated a great consistency with International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method (HPLC/CE) values ( 5 ). However, the effect of thalassemia on the CE method is unclear.…”

Evaluation of different immunoassays for the quantitative detection of Epstein–Barr virus capsid antigen immunoglobulin A using a candidate reference

“…The precision was evaluated according to the EP15-A2 protocol of the Clinical and Laboratory Standards Institute (CLSI) [17]. The original reference and 1:16 predilution were analyzed three times per day during a period of five consecutive workdays(n = 15 per level).…”