Implementation of buffy coat platelet component production: comparison to platelet-rich plasma platelet production
Implementation of buffy coat platelet component production: comparison to platelet-rich plasma platelet production
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DOI：
10.1111/j.1537-2995.2008.01836.x
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发表时间：
2008-11-01
期刊：
影响因子：
2.9
通讯作者：
Devine, Dana V.
中科院分区：
文献类型：
--
作者：
Levin, Elena;Culibrk, Brankica;Devine, Dana V.
血沉棕黄层（BC）生产血小板（PLT）已在欧洲成功使用了二十多年。目前，加拿大血液服务中心正在实施BC方法。本文总结了为确认从全血生产PLT的工艺而进行的验证试验的结果，并比较了在常规生产中通过富含PLT的血浆方法（PRP-PC）或BC方法（BC-PC）生产的PLT的质量。验证数据包括用于常规质量控制的变量（QC; pH、PLT计数、体积、无菌性、残留白色血细胞计数）以及PLT的非常规检测，以检测储存期间的PLT活化、代谢变化，血小板对低渗休克的反应性和腺苷二磷酸诱导的形态改变程度。在第1天和第6天检测BC-PC。生产运行的QC包括在第6天进行的相同常规检测。在验证和中试实施期间，通过BC方法生产的PLT在产量、体积、pH值和白细胞减少方面符合所有加拿大标准协会标准。额外的确认试验表明发生了中等水平的PLT储存病变。与PRP-PC相比，BC-PC的体外变量（本研究中的pH值或与文献相比的其他标志物）更好，表明BC-PC在储存期间具有较少的生产相关损伤证据和改善的PLT质量。通过BC方法从全血生产的PLT浓缩物在过夜保持后具有实验室变量，表明质量高于PRP方法生产的浓缩物。
Buffy coat (BC) production of platelets (PLTs) has been successfully used in Europe for more than two decades. Currently, Canadian Blood Services is implementing the BC method. This article summarizes results of the validation testing performed to qualify the process of PLT production from whole blood and compares the quality of PLTs produced in routine production by either the PLT-rich plasma method (PRP-PCs) or the BC method (BC-PCs).Validation data included variables used for routine quality control (QC; pH, PLT count, volume, sterility, residual white blood cell count) as well as nonroutine testing of PLTs for PLT activation, metabolic changes during storage, and PLT responsiveness to hypotonic shock and the extent of shape change induced by adenosine 5'-diphosphate. BC-PCs were tested on Days 1 and 6. QC of production runs included the same routine tests performed on Day 6.PLTs produced by the BC method during validation and pilot implementation met all Canadian Standards Association standards with respect to yield, volume, pH, and leukoreduction. Additional validation testing indicated a moderate level of PLT storage lesion development. In comparison to PRP-PCs, in vitro variables of BC-PCs, either pH in this study, or other markers compared to the literature were better, suggesting that BC-PCs have less evidence of production-related damage and improved PLT quality during storage.PLT concentrates produced from whole blood by the BC method after an overnight hold have laboratory variables suggestive of a higher quality than those concentrates produced by the PRP method.