UNASSIGNED: We evaluated the instrument\'s precision based on CLSI protocol EP-05-A3. A comparison of the two analysis modes of GR01 against the standard mode of HLC-723G11 was performed on 100 whole blood samples. The GR01 long mode was compared with affinity HPLC (AF-HPLC) for detecting common Hb-Vars (HbE, HbD, HbS, and HbC, >20 samples). To examine the detection capability for minor Hb-Vars, we analyzed 26 Hb-Vars using multiple analyzers, including both analysis modes of GR01.
UNASSIGNED: Both modes of GR01 had within-laboratory coefficients of variation of ≤1.0 % from four samples with HbA1c concentrations of 32-86 mmol/mol. Good correlation was observed between GR01 and HLC-723G11. The results for HbA1c detection in the presence of the major variants revealed a strong correlation between the long mode of GR01 and AF-HPLC (r = 0.986-0.998), and the difference biases ranged 0.1-1.9 mmol/mol. In the long mode, only one variant had a difference bias exceeding 14 % [10 % (%NGSP)].
UNASSIGNED: The two analysis modes of GR01 were fast and had high accuracy and reproducibility, indicating their utility for routine clinical use in measuring HbA1c samples with Hb-Vars.
■我们根据CLSI协议EP-05-A3评估了仪器的精度。对100个全血样品进行GR01的两种分析模式与HLC-723G11的标准模式的比较。将GR01长模式与亲和HPLC(AF-HPLC)进行比较,以检测常见的Hb-Vars(HbE,HBD,HBS,HbC,>20个样品)。为了检查次要Hb-Vars的检测能力,我们使用多个分析仪分析了26个Hb-Vars,包括GR01的两种分析模式。
■GR01的两种模式均具有来自HbA1c浓度为32-86mmol/mol的四个样品的实验室内变异系数≤1.0%。在GR01和HLC-723G11之间观察到良好的相关性。在存在主要变体的情况下检测HbA1c的结果揭示了GR01的长模式与AF-HPLC之间的强相关性(r=0.986-0.998),差异偏差为0.1-1.9mmol/mol。在长模式下,只有一个变异体的差异偏差超过14%[10%(%NGSP)].
■GR01的两种分析模式快速,具有较高的准确性和重现性,表明它们在用Hb-Vars测量HbA1c样品中的常规临床用途。