Long-term stability of international standards for thromboplastin stored at-20°C,-70°C, and-150°C
Long-term stability of international standards for thromboplastin stored at-20°C,-70°C, and-150°C
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DOI：
10.1016/j.thromres.2015.04.033
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发表时间：
2015-07-01
影响因子：
7.5
通讯作者：
Hubbard, A. R.
中科院分区：
文献类型：
--
作者：
van den Besselaar, A. M. H. P.;Abdoel, C. F.;Hubbard, A. R.
背景：长期稳定性是所有国际生物标准的一项基本要求。现行国际凝血活酶标准品，即RBT/05（兔脑凝血活酶）和rTF/09（重组人组织因子）的主要储备品储存于 -20℃。本研究的目的是评估RBT/05和rTF/09的国际敏感指数（ISI）的长期稳定性。
方法：RBT/05和rTF/09的部分主要储备品分别储存于 -70℃和 -150℃，长达38个月。在不同时间点从储存于 -20℃、 -70℃和 -150℃的材料中取样。将样品复溶，并使用来自健康受试者以及接受维生素K拮抗剂（VKA）治疗的患者的血浆样本在凝血酶原时间（PT）试验中进行分析。将储存于 -20℃的标准品所获得的PT值与储存于 -70℃和 -150℃的标准品所获得的PT值进行比较。通过正交回归法利用PT值计算相对ISI值。
结果：储存于 -20℃、 -70℃和 -150℃的材料的ISI值之间没有重大差异。随着储存时间没有显著趋势。
结论：国际标准品RBT/05和rTF/09的ISI值在 -20℃、 -70℃和 -150℃的储存温度下似乎是稳定的。（C）2015爱思唯尔有限公司。保留所有权利。
Background: Long-term stability is an essential requirement for all international biological standards. The main stocks of the current international standards for thromboplastin, i.e. RBT/05 (rabbit brain thromboplastin) and rTF/09 (recombinant human tissue factor), are stored at -20 degrees C. The aim of the present study is to assess the long-term stability of the international sensitivity index (ISI) for RBT/05 and rTF/09.Methods: Part of the main stocks of RBT/05 and rTF/09 were stored at -70 degrees C and -150 degrees C, up to 38 months. At various time points samples were taken from the materials stored at -20 degrees C, -70 degrees C, and -150 degrees C. The samples were reconstituted and analysed in the prothrombin time (PT) test using plasma samples derived from healthy subjects and patients treated with vitamin K-antagonists (VKA). The PT's obtained with the standards stored at -20 degrees C were compared to the PT's obtained with the standards stored at -70 degrees C and at -150 degrees C. The PT's were used to calculate relative ISI values by means of orthogonal regression.Results: There were no important differences between the ISI values for the materials stored at -20 degrees C, -70 degrees C, and -150 degrees C. There was no significant trend with storage time.Conclusion: The ISI values for the international standards RBT/05 and rTF/09 appear to be stable at storage temperatures of -20 degrees C, -70 degrees C, and -150 degrees C. (C) 2015 Elsevier Ltd. All rights reserved.