利用患者糖化血红蛋白A1c数据的系列差异评估Capillarys 2 Flex Piercing®的长期不精密度：与两种常见免疫测定法的比较
Evaluation of the long-term imprecision of the Capillarys 2 Flex Piercing® with serial differences in patient Hemoblogin A1c data: A comparison with two common immunoassays.
作者信息
Guérin Renée, Dugré-Brisson Samuel
机构信息
Département de biologie médicale, Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-St-Jean, Hôpital de Chicoutimi, Saguenay, Québec, Canada.
Département de biologie médicale, Centre Intégré de Santé et de Services Sociaux des Laurentides, Hôpital régional de St-Jérôme, St-Jérôme, Québec, Canada.
出版信息
Clin Biochem. 2016 Apr;49(6):502-504. doi: 10.1016/j.clinbiochem.2015.11.015. Epub 2015 Nov 21.
UNLABELLED
Since HbA1c became a diagnostic criterion for type 2 diabetes, assays measuring this analyte were required to be analytically stronger. Although precision of Sebia Capillarys 2 Flex Piercing® was previously evaluated with standard methods and material, we wanted to document the long-term performance of this analyzer in two different centers.
DESIGN AND METHODS
In this study, we evaluated, with a non-conventional methodology, the analytical precision of the Sebia Capillarys 2 Flex Piercing® using HbA1c patient data and compared it with two different common commercial immunoassays.
RESULTS
CV of 1.33% and 1.32% was obtained in the two centers for the electrophoretic technique compared to 2.66% and 3.92% for the Roche Cobas Integra 800® and Beckman Synchron DxC® immunoassays technique respectively.
CONCLUSIONS
Our results show that capillary electrophoresis is more robust than the 2 immunoassays tested for long-term precision and even exceeds minimal requirements recommended.
未标注
自从糖化血红蛋白（HbA1c）成为2型糖尿病的诊断标准以来，对测量该分析物的检测方法在分析性能上有了更高要求。尽管之前已使用标准方法和材料对Sebia Capillarys 2 Flex Piercing®的精密度进行了评估，但我们仍希望记录该分析仪在两个不同中心的长期性能。
设计与方法
在本研究中，我们采用一种非传统方法，利用HbA1c患者数据评估了Sebia Capillarys 2 Flex Piercing®的分析精密度，并将其与两种不同的常见商业免疫测定法进行比较。
结果
电泳技术在两个中心获得的变异系数（CV）分别为1.33%和1.32%，而罗氏Cobas Integra 800®和贝克曼库尔特Synchron DxC®免疫测定技术的变异系数分别为2.66%和3.92%。
结论
我们的结果表明，对于长期精密度而言，毛细管电泳比所测试的两种免疫测定法更稳定，甚至超过了推荐的最低要求。
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