PDF(Pubmed)
Abstract：
UNASSIGNED: Most glycated hemoglobin A1c (HbA1c) analytical reagents used were obtained from the analyzer\'s manufacturer. However, clinical laboratories need more choices for HbA1c analytical reagents to overcome the limitations of dedicated reagents for special analyzers. We developed new mobile phase buffers as HbA1c diagnostic reagents and evaluated their analytical performance for the HbA1c assay.
UNASSIGNED: Different mobile phase buffers used as HbA1c diagnostic reagents were prepared using different concentrations of sodium salts. According to the Clinical and Laboratory Standards Institute (CLSI) recommendation guidelines, the analytical performances of the newly developed mobile phase buffers were evaluated on an ARKRAY HA-8160 Analyzer. Both quality controls and clinical blood samples were used in these experiments. To assess the quality of the newly developed mobile phase buffers, precision, accuracy, linearity, carryover, interference, bias, correlation with commercial reagents, and stability were analyzed.
UNASSIGNED: The CVs of intra-assay precision and interassay precision of quality control and clinical.There were fewer than 1.00 % blood sample assays using the newly developed mobile phase buffer. The RDs of accuracy were less than 1.00 %. Linearity: R2 = 0.9998 in the concentration range of 4.40%-17.30 %. Carryover: 0.00 %. Reagent comparison revealed that the Pearson regression equation was Y = 0.9884x+0.05692 (R2 = 0.9977), and the Bland-Altman mean difference was -0.02650 % (CI: -0.2121 %-0.1591 %) between the two analytical reagents. Stability was also acceptable within 12 months. This mobile phase buffer showed good anti-interference ability.
UNASSIGNED: The newly developed mobile phase buffers demonstrated good analytical performance and were suitable for clinical HbA1c assays on an ARKRAY HA-8160 Analyzer.
UNASSIGNED: Different mobile phase buffers used as HbA1c diagnostic reagents were prepared using different concentrations of sodium salts. According to the Clinical and Laboratory Standards Institute (CLSI) recommendation guidelines, the analytical performances of the newly developed mobile phase buffers were evaluated on an ARKRAY HA-8160 Analyzer. Both quality controls and clinical blood samples were used in these experiments. To assess the quality of the newly developed mobile phase buffers, precision, accuracy, linearity, carryover, interference, bias, correlation with commercial reagents, and stability were analyzed.
UNASSIGNED: The CVs of intra-assay precision and interassay precision of quality control and clinical.There were fewer than 1.00 % blood sample assays using the newly developed mobile phase buffer. The RDs of accuracy were less than 1.00 %. Linearity: R2 = 0.9998 in the concentration range of 4.40%-17.30 %. Carryover: 0.00 %. Reagent comparison revealed that the Pearson regression equation was Y = 0.9884x+0.05692 (R2 = 0.9977), and the Bland-Altman mean difference was -0.02650 % (CI: -0.2121 %-0.1591 %) between the two analytical reagents. Stability was also acceptable within 12 months. This mobile phase buffer showed good anti-interference ability.
UNASSIGNED: The newly developed mobile phase buffers demonstrated good analytical performance and were suitable for clinical HbA1c assays on an ARKRAY HA-8160 Analyzer.
摘要：
■使用的大多数糖化血红蛋白A1c（HbA1c）分析试剂来自分析仪的制造商。然而,临床实验室需要更多的HbA1c分析试剂选择，以克服专用试剂用于特殊分析仪的局限性。我们开发了新的流动相缓冲液作为HbA1c诊断试剂，并评估了其对HbA1c测定的分析性能。
■使用不同浓度的钠盐制备用作HbA1c诊断试剂的不同流动相缓冲液。根据临床和实验室标准协会（CLSI）推荐指南，在ARKRAYHA-8160分析仪上评估了新开发的流动相缓冲液的分析性能。在这些实验中使用质量对照和临床血液样品。为了评估新开发的流动相缓冲液的质量，精度,准确度,线性度结转,干扰,偏见，与商业试剂的相关性，并对稳定性进行了分析。
■质量控制和临床的测定内精密度和测定间精密度的CV。使用新开发的流动相缓冲液进行少于1.00%的血液样品测定。准确度的RD小于1.00%。线性:在4.40%-17.30%的浓度范围内,R2=0.9998。结转:0.00%。试剂比较显示,Pearson回归方程为Y=0.984x+0.05692(R2=0.9977),两种分析试剂之间的Bland-Altman平均差为-0.02650%(CI:-0.211%-0.1591%)。在12个月内稳定性也是可接受的。该流动相缓冲器具有良好的抗干扰能力。
■新开发的流动相缓冲液显示出良好的分析性能，适用于ARKRAYHA-8160分析仪上的临床HbA1c测定。
■使用不同浓度的钠盐制备用作HbA1c诊断试剂的不同流动相缓冲液。根据临床和实验室标准协会（CLSI）推荐指南，在ARKRAYHA-8160分析仪上评估了新开发的流动相缓冲液的分析性能。在这些实验中使用质量对照和临床血液样品。为了评估新开发的流动相缓冲液的质量，精度,准确度,线性度结转,干扰,偏见，与商业试剂的相关性，并对稳定性进行了分析。
■质量控制和临床的测定内精密度和测定间精密度的CV。使用新开发的流动相缓冲液进行少于1.00%的血液样品测定。准确度的RD小于1.00%。线性:在4.40%-17.30%的浓度范围内,R2=0.9998。结转:0.00%。试剂比较显示,Pearson回归方程为Y=0.984x+0.05692(R2=0.9977),两种分析试剂之间的Bland-Altman平均差为-0.02650%(CI:-0.211%-0.1591%)。在12个月内稳定性也是可接受的。该流动相缓冲器具有良好的抗干扰能力。
■新开发的流动相缓冲液显示出良好的分析性能，适用于ARKRAYHA-8160分析仪上的临床HbA1c测定。
