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用于凝血因子VIII检测的质量保证方案在用于分馏制备凝血因子VIII浓缩物的人血浆质量监测中的重要性。

Importance of a quality assurance scheme for factor VIII assays in quality monitoring of human plasma destined for fractionation into factor VIII concentrate.

作者信息

Gabra G S, Prowse C V, Boulton F E

机构信息

Glasgow and West of Scotland Blood Transfusion Centre at Law Hospital Carluke, Lanarkshire, UK.

出版信息

Vox Sang. 1989;56(2):65-70. doi: 10.1111/j.1423-0410.1989.tb04951.x.

DOI:10.1111/j.1423-0410.1989.tb04951.x
PMID:2501933
Abstract

A national quality assurance scheme has been established to monitor the validity of factor VIII assays performed by the various laboratories of the Scottish National Blood Transfusion Service engaged in collection and processing of donor plasma destined for fractionation. The results over the first 3-year period show that comparable assay values can be obtained by participating centres using a common standard, despite differences in equipment, methods or substrate chosen for the one-stage assay. The results also showed that chromogenic factor VIII assays correlated well with the one-stage method. Random factor VIII assays performed on plasma, harvested and frozen within 18 h from collection, were analysed to validate recently proposed Scottish specifications which stipulate that 70% of plasma donations destined for fractionation should contain at least 0.7 IU/ml. Plasma harvested and frozen between 8 and 18 h from collection did not meet the specified level in any of the regional centres. This nationally specified level was also not met by plasma harvested and frozen within 8 h from collection in spite of being achieved individually by three regional centres. Assays performed on large plasma pools at the Fractionation Centre suggested loss of some factor VIII during storage, transportation and thawing of plasma prior to bulk processing.

摘要

已建立一项国家质量保证计划,以监测苏格兰国家输血服务中心从事采集和处理用于分馏的供体血浆的各个实验室所进行的凝血因子 VIII 检测的有效性。头三年的结果表明,尽管各参与中心在用于单步检测的设备、方法或底物方面存在差异,但使用通用标准仍可获得可比的检测值。结果还表明,发色底物法检测凝血因子 VIII 与单步检测法相关性良好。对采集后 18 小时内收获并冷冻的血浆进行随机凝血因子 VIII 检测,以验证最近提出的苏格兰规格,该规格规定,70% 用于分馏的血浆捐献应至少含有 0.7 IU/ml。在任何区域中心,采集后 8 至 18 小时收获并冷冻的血浆均未达到规定水平。尽管有三个区域中心个别达到了规定水平,但采集后 8 小时内收获并冷冻的血浆也未达到全国规定的水平。在分馏中心对大量血浆池进行的检测表明,在血浆进行批量处理之前的储存、运输和解冻过程中,一些凝血因子 VIII 有所损失。

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