Analytical evaluation and quality assessment of the ARKRAY ADAMS A1c Lite HA-8380V for HbA1c

被引：0

作者：

Urrechaga, Eloisa ^{[1
]}

机构：

[1] Hosp Galdakao Usansolo, Lab, Galdakao, Vizcaya, Spain

来源：

SCANDINAVIAN JOURNAL OF CLINICAL & LABORATORY INVESTIGATION | 2023年 / 83卷 / 05期

关键词：

HbA1c; diabetes; performance specifications; verification; ARKRAY ADA MS A1c Lite HA-8380V analyzer; BIOLOGICAL VARIATION; GLYCATED HEMOGLOBIN; HBA(1C); HA-8190V; A(1C);

D O I：

10.1080/00365513.2023.2225222

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

Introduction: ARKRAY ADAMS A1c Lite HA-8380V is a fully automated high- performance liquid chromatography system for the measurement of HbA1c. We aimed to evaluate its analytical performance using the Variant Mode. Methods: Carry-over, linearity, imprecision, trueness, interferences and comparison against ARKRAY ADAMS A1c HA-8180V and HA-8180T analyzers were studied. Results: Total CVs 0.93% (IFCC units), 0.63% (NGSP units) at low concentration and 1.01% (IFCC) 0.74% (NGSP), at high concentration. Mean difference with the target values was -0.44 mmol/mol (IFCC) -0.04% (NGSP). Carry-over, linearity and method comparison were excellent. The results were not affected in the range of total Hb 39-199 g/L, labile fraction 5.7%, carbamylated Hb 9.1% nor acetylated Hb 7.8%, effect of common variants was negligible. Conclusions: the analyzer demonstrated very good analytical performances, according to the consensus criteria established for HbA1c; it is adequate for laboratories with medium-low workloads.

引用

页码：358 / 365

页数：8

共 34 条

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