评估Sebia Minicap Flex穿刺毛细管电泳用于血红蛋白病检测的情况。
Evaluation of the Sebia Minicap Flex Piercing capillary electrophoresis for hemoglobinopathy testing.
作者信息
Oyaert M, Van Laer C, Claerhout H, Vermeersch P, Desmet K, Pauwels S, Kieffer D
机构信息
Department of Laboratory Medicine, University Hospital Leuven, Leuven, Belgium.
出版信息
Int J Lab Hematol. 2015 Jun;37(3):420-5. doi: 10.1111/ijlh.12305. Epub 2014 Oct 16.
INTRODUCTION
Capillary zone electrophoresis (CZE) at alkaline pH is one of the techniques used for hemoglobinopathy screening. In this study, an evaluation of the performance of a lower throughput CZE instrument, the Sebia Minicap Flex Piercing system, for this purpose is reported for the first time.
METHODS
The analytical performance of the Sebia Minicap Flex Piercing system was evaluated. Furthermore, a method comparison between the Sebia Minicap Flex Piercing and two HPLC methods, that is, the Bio-Rad Variant Classic(™) and the Bio-Rad D-10(™) systems was performed by measuring samples with and without clinically relevant hemoglobin disorders.
RESULTS
The analytical performance was acceptable for the determination of HbA, HbA2, HbS, and HbF, with an imprecision ≤2.0%. Method comparison showed a linear correlation for HbA2, HbF, and HbS measurements. Clinical concordance was acceptable when comparing CZE and HPLC.
CONCLUSIONS
Lower throughput CZE using the Sebia Minicap Flex Piercing can be used for precise and accurate first line screening and follow-up of hemoglobinopathies.
引言
碱性pH条件下的毛细管区带电泳（CZE）是用于血红蛋白病筛查的技术之一。在本研究中，首次报道了对一种通量较低的CZE仪器——Sebia Minicap Flex Piercing系统用于此目的的性能评估。
方法
评估了Sebia Minicap Flex Piercing系统的分析性能。此外，通过测量有无临床相关血红蛋白疾病的样本，对Sebia Minicap Flex Piercing系统与两种高效液相色谱（HPLC）方法，即伯乐Variant Classic™和伯乐D - 10™系统进行了方法比较。
结果
对于HbA、HbA2、HbS和HbF的测定，分析性能是可接受的，不精密度≤2.0%。方法比较显示HbA2、HbF和HbS测量呈线性相关。比较CZE和HPLC时，临床一致性是可接受的。
结论
使用Sebia Minicap Flex Piercing的低通量CZE可用于血红蛋白病的精确、准确的一线筛查和随访。
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