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新鲜冰冻血浆与混合的溶剂/去污剂处理血浆(OctaplasLG)的比较生化研究,重点关注蛋白S及其在不同凝血酶生成检测设置中的影响。

Comparative biochemical studies of fresh frozen plasma and pooled solvent/detergent-treated plasma (octaplasLG ) with focus on protein S and its impact in different thrombin generation assay set-ups.

作者信息

Heger A, Janisch S, Pock K, Römisch J

机构信息

Octapharma Pharmazeutika Produktiosges.m.b.H, Research & Development, Vienna, Austria.

出版信息

Vox Sang. 2016 Oct;111(3):266-273. doi: 10.1111/vox.12420. Epub 2016 May 27.

Abstract

BACKGROUND AND OBJECTIVES

The solvent/detergent treatment enables effective and robust inactivation of all lipid-enveloped viruses, but also inactivates partly sensitive plasma proteins such as protein S. The aim of this study was to investigate the thrombin generation capacity of octaplasLG , in particular focusing on the function of protein S in thrombin generation assay and the impact of assay settings.

MATERIALS AND METHODS

Sixteen octaplasLG batches and 32 units of single donor fresh frozen plasma (FFP) were investigated. For protein S, both functional activity and free antigen levels were measured. Thrombin generation assay was performed using two fluorogenic tests with different triggers. Finally, rotational thromboelastometry was performed.

RESULTS

Mean protein S levels were lower in octaplasLG , but a wider range of values was found for FFP. Clotting parameters and thrombin generation capacities overlapped between the two plasma groups as demonstrated using both thrombin generation assays and different triggers. Spiking studies with protein S-depleted plasma, human purified protein S or antibodies against protein S confirmed a correlation between protein S and thrombin generation capacity under specific assay conditions, especially in an assay with low tissue factor concentration.

CONCLUSION

Correlation between protein S and thrombin generation capacity was demonstrated in the TGA. Due to higher variability in protein S content in the FFP group, overlapping haemostatic potentials of the two plasma groups were found.

摘要

背景与目的

溶剂/去污剂处理能够有效且强力地灭活所有包膜病毒,但也会部分灭活诸如蛋白S等敏感血浆蛋白。本研究的目的是调查OctaplasLG的凝血酶生成能力,尤其关注蛋白S在凝血酶生成试验中的功能以及试验设置的影响。

材料与方法

研究了16批OctaplasLG和32单位单供体新鲜冰冻血浆(FFP)。对于蛋白S,同时测量了功能活性和游离抗原水平。使用两种不同触发物的荧光试验进行凝血酶生成试验。最后,进行了旋转血栓弹力图检查。

结果

OctaplasLG中的蛋白S平均水平较低,但FFP的蛋白S水平范围更广。使用凝血酶生成试验和不同触发物均表明,两组血浆的凝血参数和凝血酶生成能力存在重叠。用缺乏蛋白S的血浆、人纯化蛋白S或抗蛋白S抗体进行的加标研究证实,在特定试验条件下,尤其是在组织因子浓度较低的试验中,蛋白S与凝血酶生成能力之间存在相关性。

结论

在凝血酶生成试验中证明了蛋白S与凝血酶生成能力之间的相关性。由于FFP组中蛋白S含量的变异性较高,发现两组血浆的止血潜力存在重叠。

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