Analytical verification and quality assessment of the Tosoh HLC-723GX HbA1c analyzer

摘要

Objectives Ion-exchange high-performance liquid chromatography (IE-HPLC) has long been used as a reproducible and versatile analytical tool for HbA 1c measurement. In this study, we performed analytical verification and quality assessment of the recently introduced small IE-HPLC Tosoh HLC-723GX HbA 1c analyzer, and a comparison of results to immunoassay (IA) and capillary electrophoresis (CE). Design and methods The total imprecision of Tosoh HLC-723GX was verified according to CLSI EP15-A2 protocol using commercial control materials (C-QC) and pooled human whole blood samples (HWB). The Sigma metric was used for the evaluation of quality targets. HbA 1c results were compared to automated CE (MiniCap Flex Piercing, Sebia, France) and IA (Tina-quant HbA 1c Gen 2, Cobas Integra 400+, Roche Diagnostics, USA) procedures. Results The total imprecision of Tosoh HLC-723GX-HbA 1c for IFCC(mmol/mol) and NGSP(%) units was: 1.91/1.25% (HbA 1c =31 mmol/mol/5.0%) and 0.51/0.63% (HbA 1c =84 mmol/mol/9.8%) for C-QC, and 0.39/0.2% (HbA 1c =47 mmol/mol/6.5%) and 0.77/0.46% (HbA 1c =94 mmol/mol/10.8%) in HWB samples, respectively. Bland-Altman analysis did not reveal any deviation of the results between Tosoh HLC-723GX and CE: mean difference 0.0% (95%CI: ?0.02927 to 0.02653%), while the mean HbA 1c difference against IA was ?0.07% (95%CI: ?0.1039 to ?0.02765). At the selected HbA 1c clinical decision level (48 mmol/mol/6,5%), six sigma analysis gave σ value of 3.91, within a desirable classification of performance. Conclusion The analytical performance of the Tosoh HLC-723GX complies with the rigorous quality criteria for clinical use of HbA 1c , with the results comparable to the CE procedure. Tosoh HLC-723GX provides a plausible analytical choice for reliable HbA 1c measurement in low-volume laboratories. Highlights ? Compliance to the rigorous quality targets is necessary for the reliable clinical use of HbA 1c . ? A small, fully automated benchtop HbA 1c analyzer (Tosoh HLC-723GX) was evaluated. ? Tosoh HLC-723GX anaylzer met the six sigma-based quality targets. ? Low-volume laboratories could provide clinically reliable HbA1c results by the Tosoh HLC-723GX analyzer.