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首页> 外文期刊>Journal of Medical Biochemistry >Analytical Evaluation of the Novel Helena V8 Capillary Electrophoresis System
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Analytical Evaluation of the Novel Helena V8 Capillary Electrophoresis System

机译：新型Helena V8毛细管电泳系统的分析评估

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SummaryBackground: Capillary electrophoresis (CE) is used for the screening of protein abnormalities in serum and other biological fluids. Since the Helena V8 CE system has been recently commercialized, the aim of this study was to assess its analytical performance under routine laboratory conditions.Methods: The evaluation of Helena V8 (Medical Systems S.p.A., Genova, Italy) for protein fractions (i.e., albumin, alpha-1, alpha-2, beta-1, beta-2, gamma, albumin/globulin ratio [A/G]) and monoclonal component (MC) quantification included imprecision studies, linearity, and comparison with Sebia Capillarys (Sebia, Evry Cedex, France), which was considered the reference analyzer.Results: The imprecision of Helena V8 on all parameters was comprised between 0.8% and 15.2%; the linearity was excellent up to an MC value of 14.5% (r=1.00). The comparison studies showed excellent Spearman’s correlations with Sebia Capillarys, with coefficients comprised between 0.84 and 0.99 (all p<0.001). The mean bias of Helena V8 versus Sebia Capillarys was -0.02% for G/A, -0.2% for albumin, 2.1% for alpha-1, 0.1% for alpha-2, 0.3% for beta-1, -0.2% for beta-2, -2.2% for gamma and 1 g/L for MC.Conclusions: The results of this evaluation attest that Helena V8 is a suitable alternative for routine separation and quantification of protein fractions and monoclonal component.
机译：摘要背景：毛细管电泳（CE）用于筛查血清和其他生物液体中的蛋白质异常。由于Helena V8 CE系统最近已经商业化，因此本研究的目的是评估其在常规实验室条件下的分析性能。方法：对Helena V8（医疗系统SpA，意大利热那亚）的蛋白质组分（即白蛋白）进行评估，alpha-1，alpha-2，beta-1，beta-2，γ，白蛋白/球蛋白之比[A / G]）和单克隆组分（MC）定量分析包括不精确性研究，线性度以及与塞尔维亚毛细管（Sebia，结果：Helena V8在所有参数上的不精确度在0.8％至15.2％之间;线性度非常好，MC值为14.5％（r = 1.00）。对比研究表明，Spearman与Sebia毛细管的相关性极好，系数介于0.84和0.99之间（所有p <0.001）。 Helena V8与Sebia毛细管的平均偏差为G / A为-0.02 ％，白蛋白为-0.2 ％，α-1为2.1 ％，α-2为0.1 ％，β-1为0.3 ％ Beta-2为-0.2％，γ为-2.2％，MC为1 g / L。结论：评估结果证明Helena V8是常规分离和定量蛋白质级分和单克隆成分的合适替代品。

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