Multicentre evaluation of the Premier Hb9210 HbA1c analyser

Abstract

Background The accurate and precise quantification of HbA1c is essential for the diagnosis and routine monitoring of patients with diabetes. We report an evaluation of the Trinity Biotech Premier Hb9210 analyser (Bray, Ireland/Kansas City, US), a boronate affinity chromatography-based high performance liquid chromatography (HPLC) system for the measurement of glycated haemoglobin. Methods We evaluated the analytical performance of the Hb9210 as part of a multicentre evaluation. The effect of haemoglobin variants, other potential interferences and the performance in comparison to both the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and National Glycohemoglobin Standardization Program (NGSP) reference systems, was assessed. Most of the centres participating also act as reference laboratories for both the IFCC standardisation network for HbA1c and the NGSP. Results The combined data from all centres showed total CVs of 2.71%, 2.32% and 2.14% at low medium and high values respectively for mmol/mol (SI units) and 1.62%, 1.59% and 1.68% for % (NGSP units), which are well below the recommended upper limits of 3% CV for SI (IFCC) units and 2% CV for % (NGSP). The analyser showed a good correlation to HbA1c methods currently used in clinical practice and the IFCC reference method procedure. Haemoglobin variants AC, AS, AE and AD do not affect the measurement of HbA1c. Overall the Hb9210 performs well across the whole analytical range. Conclusions The Hb9210 performs well and is suitable for clinical application in the analysis of HbA1c.

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

“…Accuracy verification demonstrated a great consistency among the four systems tested in comparison with the IFCC values. The high analytical performances in terms of precision, linearity, and accuracy of all four systems were in accordance with previous studies ( 15 , 24 - 27 ) and manufacturer claims.…”

“…The measurement of HbA 1c by the Capillarys 2FP, Tosoh G8, and Premier Hb9210 analyzers was not subjected to common interferences such as bilirubin and triglycerides/cholesterol, and these findings confirmed the results presented previously ( 15 , 24 , 25 , 28 ). However, very high levels of triglycerides/cholesterol led to a falsely low HbA 1c value in the immunoassay using the Roche c501 system.…”

“…As the second most prevalent hemoglobinopathy worldwide, HbE is mostly found in the Far East and Southeast Asia; thus, it has been included in the present study ( 11 ). A good agreement of HbA 1c concentrations was observed between the Capillarys 2FP, Roche c501, and Premier Hb9210 analyzers; therefore, it was concluded that the HbA1c measurements on these three systems were not affected by the presence of the HbE variant, confirming the results reported previously ( 9 , 10 , 15 , 23 - 25 , 28 ). However, on the Tosoh G8 instrument, the presence of HbE induces an extra peak on the chromatogram, which is not reportable as shown previously ( 10 , 23 ).…”

“…In this study, no effect was reported on the quantification of HbA 1c by the two methods based on the principle of molecular charge. The current study showed that treatment with glucose up to 277.78 mmol/L in vitro , much higher than the concentration reported previously ( 15 , 24 , 29 ) and the manufacturer’s claims, did not interfere with the HbA 1c measurement, suggesting that the blood LA 1c contents may not affect the quantification of HbA 1c by the four tested methods.…”

“…Whole blood samples (N = 157) and umbilical cord blood (N = 1) were collected in EDTA-containing tubes (2.0 mL, BD Diagnostics, Franklin Lakes, NJ, USA) and kept at 4 ± 2 şC to be analyzed within 24 h. For precision, method comparison, and analytical interference of Hb variants, the samples were kept at - 80 °C ( 14 , 15 ) and analyzed within 1 month. Whole blood samples were obtained from the Clinical Laboratory of Guangdong Provincial Hospital of Chinese Medicine.…”