Impact of a product-specific reference standard for the measurement of a PEGylated rFVIII activity: the Swiss Multicentre Field Study
Impact of a product-specific reference standard for the measurement of a PEGylated rFVIII activity: the Swiss Multicentre Field Study
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DOI：
10.1111/hae.13250
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发表时间：
2017-07-01
期刊：
影响因子：
3.9
通讯作者：
Fontana, P.
中科院分区：
文献类型：
--
作者：
Bulla, O.;Poncet, A.;Fontana, P.
简介：测量因子VIII（FVIII）活性在其被修饰时可能具有挑战性，例如当FVIII被聚乙二醇化以增加其循环半衰期时。使用产品特定参比标准品可能有助于避免此问题。目的：评估在瑞士八个主要实验室中使用产品特定参比标准品测量BAX 855（聚乙二醇化的凝血因子VIII）的凝血因子VIII活性的影响。方法：加标五种不同浓度的BAX 855的缺乏凝血因子VIII的血浆，加上一份对照凝血因子VIII样本，被送往参与实验室。他们测量FVIII活性通过使用一个阶段（OSA）或显色测定（CA）对他们的地方或产品特定的参考standard.Results：当使用当地的参考标准，有一个高估的BAX 855活性相比，目标浓度，无论是与OSA和CA。使用产品特定参比标准品可降低该效应：使用OSA和当地参比标准品的平均回收率范围为127.7%-213.5%，而使用产品特定参比标准品的平均回收率范围为110%-183.8%，使用CA和当地参比标准品时，从146.3%至182.4%，而使用产品特定参比标准品时，从72.7%至103.7%。结论：在这项体外研究中，参比标准品的类型对BAX 855活性的测定有重大影响。当使用产品特定参比标准品时，评价更准确和精密。
Introduction: Measuring factor VIII (FVIII) activity can be challenging when it has been modified, such as when FVIII is pegylated to increase its circulating half-life. Use of a product-specific reference standard may help avoid this issue. Aim:Evaluate the impact of using a product-specific reference standard for measuring the FVIII activity of BAX 855 - a pegylated FVIII - in eight of Switzerland's main laboratories.Methods: Factor VIII-deficient plasma, spiked with five different concentrations of BAX 855, plus a control FVIII sample, was sent to the participating laboratories. They measured FVIII activity by using either with a one-stage (OSA) or the chromogenic assay (CA) against their local or a product-specific reference standard.Results: When using a local reference standard, there was an overestimation of BAX 855 activity compared to the target concentrations, both with the OSA and CA. The use of a product-specific reference standard reduced this effect: mean recovery ranged from 127.7% to 213.5% using the OSA with local reference standards, compared to 110% to 183.8% with a product-specific reference standard, and from 146.3% to 182.4% using the CA with local reference standards compared to 72.7% to 103.7% with a product-specific reference standard. Conclusion: In this in vitro study, the type of reference standard had a major impact on the measurement of BAX 855 activity. Evaluation was more accurate and precise when using a product-specific reference standard.