对 ARKRAY ADAMS A1c Lite HA-8380V 进行 HbA1c 的分析评估和质量评估。

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

机构信息

Laboratory, Hospital Galdakao - Usansolo, Galdakao, Vizcaya, Spain.

出版信息

Scand J Clin Lab Invest. 2023 Sep;83(5):358-365. doi: 10.1080/00365513.2023.2225222. Epub 2023 Jun 23.

DOI:10.1080/00365513.2023.2225222

PMID:37352386

Abstract

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.

摘要

简介

ARKRAY ADAMS A1c Lite HA-8380V 是一种全自动高性能液相色谱系统，用于测量 HbA1c。我们旨在使用变异模式评估其分析性能。

方法

研究了交叉污染、线性、不精密度、准确度、干扰以及与 ARKRAY ADAMS A1c HA-8180V 和 HA-8180T 分析仪的比较。

结果

低浓度时总 CVs 为 0.93%（IFCC 单位）、0.63%（NGSP 单位），高浓度时为 1.01%（IFCC）0.74%（NGSP）。与靶值的平均差值为-0.44mmol/mol（IFCC）-0.04%（NGSP）。交叉污染、线性和方法比较均极佳。在总 Hb 39-199g/L、不稳定分数 5.7%、氨基甲酰化 Hb 9.1%和乙酰化 Hb 7.8%范围内，结果不受影响，常见变异的影响可以忽略不计。