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首页> 外文期刊>Advances in hematology >Assessing the Performance of Extended Half-Life Coagulation Factor VIII, FC Fusion Protein by Using Chromogenic and One-Stage Assays in Saudi Hemophilia A Patients
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Assessing the Performance of Extended Half-Life Coagulation Factor VIII, FC Fusion Protein by Using Chromogenic and One-Stage Assays in Saudi Hemophilia A Patients

机译：通过在沙特血友病中使用发色性和一阶段测定来评估延长半衰期凝固因子VIII，Fc融合蛋白的性能

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Background. The one-stage assay is the most common method to measure factor VIII activity (FVIII?:?C) in hemophilia A patients. The chromogenic assay is another two-stage test involving purified coagulation factors followed by factor Xa-specific chromogenic substrate. Aim. This study aimed to assess the discrepancy and correlation between the chromogenic and one-stage assays in measuring FVIII?:?C levels in hemophilia patients receiving Extended Half-Life Elocta? as a recombinant extended half-life coagulation factor. Methods. We performed a study comparing the measurements of FVIII?:?C levels by the chromogenic versus the one-stage assays at different drug levels. Data of FVIII?:?C levels, dosage, and the time interval from administration to measurement were retrieved from the hospital records. The correlation, mean differences, and discrepancy between the two assays were calculated. The linear regression analysis was used to predict the time interval till reaching 1% FVIII?:?C. Results. Fourteen patients with 56 samples were included in the study. Of them, 13 patients were receiving Elocta? as a prophylactic, while one was receiving Elocta? on demand. One-third of these samples showed a discrepancy between the chromogenic and one-stage assays. The two assays were well correlated. Mean differences were significant at the individual and the time interval level. The time since the last Elocta? injection could significantly predict FVIII?:?C levels (β?=?0.366, P0.001). Conclusion. Our findings suggested a significant difference between both methods; the FVIII?:?C levels measured by the one-stage assay were less than those estimated by the chromogenic assay. However, the measurements of FVIII levels by the two assays were well correlated but discrepant in one-third of the samples. The levels of FVIII?:?C reach 1% after 5.4 days since the last Elocta? administration.
机译：背景。单阶段测定是血友病患者中测量因子VIII活性（FVIII？：C）的最常见方法。发色测定是另一个两级试验，涉及纯化的凝血因子，然后是因子Xa特异性的发色底物。目标。本研究旨在评估测量FVIII中的发色和单阶段测定之间的差异和相关性吗？：血友病患者中的C水平接受延长半衰期ELOCTA？作为重组延长半衰期的凝血因子。方法。我们进行了比较FVIII的测量的研究？：Δc通过色发育与不同药物水平的单阶段测定的水平。 FVIII的数据？：αc水平，剂量和从施用到测量的时间间隔从医院记录中检索。计算两个测定之间的相关性，平均差异和差异。线性回归分析用于预测达到1％FVIII的时间间隔？：？C。结果。研究中包含十四名样品56例。其中，13名患者接受Elocta？作为预防性，而人们正在接受ELOCTA？一经请求。这些样品中的三分之一显示了发色和单阶段测定之间的差异。两种测定良好相关。在个人和时间间隔水平上的平均差异是显着的。自上次elocta以来的时间？注射可显着预测FVIII？：Δc水平（β= 0.366，p <0.001）。结论。我们的研究结果表明两种方法之间有显着差异; FVIII？：ΔC含量通过单级测定测量的水平小于发色法测定的水平。然而，两种测定的FVIII水平的测量良好，但在三分之一的样品中脱离。 FVIII的水平是什么？：（如果自上次EloCTA以来5.4天后达到1％？行政。

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