European Reference Laboratory for Glycohemoglobin, Queen Beatrix Hospital, Winterswijk, The Netherlands.
Department of Clinical Chemistry, Queen Beatrix Hospital, Winterswijk, The Netherlands.
Clin Chem Lab Med. 2020 Dec 24;59(5):965-970. doi: 10.1515/cclm-2020-1300. Print 2021 Apr 27.
Hemoglobin A (HbA) is a valuable parameter in the monitoring of diabetic patients and increasingly in diagnosis of diabetes. Manufacturers continuously optimize instruments, currently the main focus is to achieve faster turnaround times. It is important that performance specifications remain of high enough standard, which is evaluated in this study for the new ARKRAY HA-8190V instrument.
The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5, EP-9 and EP-10 were applied to investigate imprecision, bias and linearity. In addition potential interferences, performance in External Quality Assessment (EQA) and performance against the HA-8180V instrument in 220 clinical samples was evaluated.
The HA-8190V demonstrates a CV of ≤0.8% in IFCC SI units (≤0.6% National Glycohemoglobin Standardization Program [NGSP]) at 34 and 102 mmol/mol levels (5.3 and 11.5% NGSP) and a bias of -0.1 mmol/mol (-0.01% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP), but with a significant slope as compared to target values. This results in a bias of -1.0 and 0.9 mmol/mol (-2.0 and 0.9% NGSP) at the 30 and 70 mmol/mol (4.9 and 8.6% NGSP) concentration level. Simulation of participation in the IFCC certification programme results in a Silver score (bias -0.1 mmol/mol, CV 1.1%). Interference in the presence of the most important Hb variants (AS, AC, AE, AD) and elevated HbA and HbF concentrations is less than 3 mmol/mol (0.3% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP).
Analytical performance of the HA-8190V is very good, especially with respect to precision and HbA quantification in the presence of the most common Hb variants.
血红蛋白 A（HbA）是监测糖尿病患者和诊断糖尿病的重要参数。制造商不断优化仪器，目前的主要重点是实现更快的周转时间。重要的是，性能规格仍保持足够高的标准，这在本研究中对新的 ARKRAY HA-8190V 仪器进行了评估。
应用临床和实验室标准协会（CLSI）协议 EP-5、EP-9 和 EP-10 来研究不精密度、偏差和线性。此外，还评估了仪器在外部质量评估（EQA）中的潜在干扰、性能以及在 220 份临床样本中的性能与 HA-8180V 仪器的比较。
HA-8190V 在 34 和 102mmol/mol 水平（5.3 和 11.5%NGSP）的 IFCC SI 单位（≤0.6%NGSP）下的 CV 为≤0.8%（≤0.6%NGSP），在 50mmol/mol（6.7%NGSP）浓度下的偏差为-0.1mmol/mol（-0.01%NGSP），但与目标值相比存在显著斜率。这导致在 30 和 70mmol/mol（4.9 和 8.6%NGSP）浓度水平的偏差为-1.0 和 0.9mmol/mol（-2.0 和 0.9%NGSP）。模拟参加 IFCC 认证计划的结果为银牌得分（偏差-0.1mmol/mol，CV1.1%）。在存在最重要的 Hb 变体（AS、AC、AE、AD）和升高的 HbA 和 HbF 浓度的情况下，干扰小于 3mmol/mol（0.3%NGSP）在 50mmol/mol（6.7%NGSP）的浓度下。
HA-8190V 的分析性能非常好，尤其是在存在最常见的 Hb 变体的情况下，HbA 的精密度和定量。
