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合作研究建立替代世界卫生组织国际标准的微小病毒 B19 DNA 核酸扩增技术(NAT)检测方法。

Collaborative study to establish a replacement World Health Organization International Standard for parvovirus B19 DNA nucleic acid amplification technology (NAT)-based assays.

机构信息

National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, UK.

出版信息

Vox Sang. 2010 Apr;98(3 Pt 2):441-6. doi: 10.1111/j.1423-0410.2009.01288.x. Epub 2009 Dec 8.

Abstract

BACKGROUND AND OBJECTIVES

The aim of the study was to replace the 1(st) World Health Organization International Standard for parvovirus B19 DNA for nucleic acid amplification technique (NAT)-based assays (code 99/800). Two lyophilized preparations (coded 99/800 and 99/802) had been evaluated in the original collaborative study. The present study re-evaluates these two preparations in terms of potency, stability and encapsidation of virus DNA.

MATERIALS AND METHODS

The 1(st) International Standard (99/800) and 99/802 were re-coded as Samples 1 and 2, respectively. The samples were distributed to six laboratories and assayed on four separate occasions. Accelerated thermal degradation samples of the two preparations were examined after storage at 20 degrees C for 7 years. Nuclease treatment was used to investigate the encapsidation of virus DNA.

RESULTS

Data were returned from a total of six different quantitative NAT-based assays. The results of the present study confirm those of the original, with no significant differences found in estimated international units (IU)/ml for the 1(st) International Standard (Sample 1 in this study) and the proposed replacement preparation, Sample 2 (99/802). Accelerated thermal degradation studies demonstrate that both samples are very stable, with no loss of potency after storage at 20 degrees C for 7 years. Both lyophilized preparations contained the majority of B19V DNA encapsidated in virions.

CONCLUSIONS

On the basis of the data presented in this collaborative study, Sample 2 (code number 99/802) was established as the 2(nd) International Standard for parvovirus B19 DNA for NAT-based assays with a potency of 10(6) IU/ml (500 000 IU/vial).

摘要

背景与目的

本研究旨在替代核酸扩增技术(NAT)检测用第 1 版世界卫生组织国际标准品(代码 99/800)的细小病毒 B19 DNA。在最初的协作研究中,对两种冻干制剂(编码为 99/800 和 99/802)进行了评估。本研究重新评估了这两种制剂在病毒 DNA 效价、稳定性和包封方面的情况。

材料与方法

第 1 版国际标准品(99/800)和 99/802 重新编码为样品 1 和样品 2。将这些样品分发给 6 个实验室,在 4 个不同的时间点进行检测。将两种制剂的加速热降解样品在 20°C 下储存 7 年后进行检查。采用核酸酶处理来研究病毒 DNA 的包封情况。

结果

共有 6 个不同的定量 NAT 检测实验室返回了数据。本研究的结果与原始研究一致,未发现第 1 版国际标准品(本研究中的样品 1)和拟议替代制剂样品 2(99/802)的国际单位(IU)/毫升之间存在显著差异。加速热降解研究表明,两种样品都非常稳定,在 20°C 下储存 7 年后效价没有损失。两种冻干制剂均含有大量包封在病毒粒子中的 B19V DNA。

结论

根据本协作研究中提供的数据,样品 2(代码 99/802)被确立为第 2 版细小病毒 B19 DNA 的 NAT 检测用国际标准品,效价为 106 IU/ml(500 000 IU/管)。

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