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ANALYTICAL VERIFICATION AND QUALITY ASSESSMENT OF A FULLY AUTOMATED IMMUNOTURBIDIMETRIC HBA1C DETERMINATION USING HBA1C ADVANCED KIT ON BECKMAN COULTER DXC 700 AU ANALYTICAL SYSTEM

BACKGROUND-AIM. The clinical indications for HbA1c measurement represent a challenge in meeting rigorous quality requirements. The aim of the study was analytical verification of HbA1c Advanced reagent (BCA) on DxC 700 AU analyser (both by BeckmanCoulter, USA) for HbA1c measurement in whole blood samples and to asses clinical reliability of results in comparison to two accredited methods. METHODS. Total imprecision was verified according to CLSI EP15-A2 protocol using commercial quality control (CQC) (ExtendSURE, Canterbury Scientific, NZ) and pooled whole blood (WB) samples. Bias was estimated with External quality control samples (ERL, 2021.1-19 ; values determined by the reference method in European Reference Laboratory for Glycohemoglobin Standardization, The Netherlands). Results were compared to Tina-quant, Gen 3 immunoassay (IM) (Cobas Integra 400+, Roche, USA) (N=174) and capillaryelectrophoresis (CE)(Minicap Flex- Piercing, Sebia, France)(N=28) on patient samples remaining after routine HbA1c analysis. RESULTS. Total imprecision of BCA method for CQC was 2, 64% (HbA1c 37 mmol/mol) and 2, 02% (HbA1c 86 mmol/mol) ; and for WB 1, 07% (HbA1c 59 mmol/mol). The deviation of the results from target reference values range was (-3 to 1 mmol/mol)[average deviation: -0.67 mmol/mol absolute, 1.42% relative]. Passing-Bablok regression showed excellent method correlation with neither constant nor proportional difference (regression equation: y=0, 9000+0, 9714x ; intercept A=0, 9000, 95% CI=-1, 0000-1, 8182 ; slope B=0, 9714 ; 95% CI=0, 9545- 1, 0000 ; Spearman's corelation coefficient 0, 997). A minimal, clinically insignificant constant difference between BCA and CE was found, with excellent correlation in study on 28 samples of pregnant women with gestational diabetes (regression eqation: Y=-1, 0000+1, 0000x ; intercept A=-1, 0000 ; 95% CI=-6, 4167 to -1, 0000 ; slope B=1, 0000 ; 95% CI=1, 0000-1, 1667). Sigma metrics result σ=4 indicates BCA meet strict quality requirements, at recommended clinical decision level 5 mmol/mol (IFCC Task Force for HbA1c). Verification of reference intervals confirmed the compliance with recommended WHO values with HbA1c intervals of 16- 36 mmol/mol. CONCLUSIONS. The HbA1c Advanced Kit method on Beckman Coulter DxC 700 AU meets all rigorous quality criteria for reliable clinical use in research, diagnosis and monitoring of diabetes

verification HbA1c ; DXC 700

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