Key result
The ARKRAY ADAMS A1c HA-8190V analyzer demonstrated high analytical performance for HbA1c measurement, with total CVs ≤0.85% (IFCC) and a mean difference with target values of -1.25 mmol/mol.
Why the study?
To evaluate the analytical performance and verify the quality of analysis of the ARKRAY ADAMS A1c HA-8190V analyzer in Variant mode according to established consensus criteria.
The ARKRAY ADAMS A1c HA-8190V analyzer provides highly reproducible and accurate HbA1c measurements suitable for high-throughput clinical laboratories.
HA-8190V meets consensus analytical criteria; leaves open whether adoption improves HbA1c-guided CV risk management.
ARKRAY ADAMS A1c HA-8190V is a fully automated high-pressure liquid chromatography (HPLC) system for the measurement of HbA1c. The runtime is 58 s per sample in the Variant mode and 24 s per sample in the Fast mode. We evaluated the analytical performance of this analyzer in the Variant mode, to verify the quality of analysis, according to the consensus criteria established for this measurand. Reproducibility, trueness, carry-over, linearity, interferences and comparison with ARKRAY ADAMS A1c HA-8180V and HA-8180T analyzers were evaluated. Total CVs were 0.76% (IFCC units) 0.55 (NGSP units) at low HbA1c concentration and 0.85% (IFCC units) 0.68 (NGSP units) at high HbA1c concentration. Mean difference with the target values was -1.25 mmol/mol (-0.119%) and total error at medium level was 2.83% (IFCC units), 2.46% (NGSP units) Carry-over was 0%. Linearity was shown in the range 27-122 mmol/mol (4.6-13.3%). The results were not affected in the range of total Hb 59-199 g/L, labile fraction up to 5.5%, carbamylated up to Hb 6.3% nor acetylated Hb up to 5.3%. Method comparison demonstrated good concordance between the methods. The analyzer demonstrated a high analytical performance adequate for routine clinical use in laboratories with high workloads.
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Eloísa Urrechaga (2023) studied HbA1c measurement. ARKRAY ADAMS A1c HA-8190V vs. ARKRAY ADAMS A1c HA-8180V and HA-8180T analyzers was evaluated on Analytical performance (reproducibility, trueness, carry-over, linearity, interferences). The ARKRAY ADAMS A1c HA-8190V analyzer demonstrated high analytical performance for HbA1c measurement, with total CVs ≤0.85% (IFCC) and a mean difference with target values of -1.25 mmol/mol.