[Cell-Dyn 3500的极值评估]。

B Schweizer, H Egelhofer, J Tarricone
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引用次数: 0

摘要

在制备不稳定血液制品期间进行的质量测试允许验证产品并确保正确应用制作程序。不稳定的血液制品必须符合部级命令所规定的若干标准。因此有必要检查一些产品的制造单位。由于Cell-Dyn 3500的原始技术将阻抗变化测量分析和流式细胞术技术分析方法结合在一起,并且其兽医模量允许在极值中计数,因此它似乎值得在血库质量控制实验室进行评估。用Optipress系统对血袋进行离心和收集肉色层制备的高值样品进行了线性研究。这项研究对22个样本进行了研究。测定了红细胞、白细胞、血小板和红细胞压积的线性关系。测量样品间污染。它关注的是血小板和白细胞的价值。使用在上述条件下制备的高细胞浓度样品和白细胞减少的血浓缩物。重复性的研究是通过处理20次3个样品,覆盖了不同的细胞计数参数的大范围值。有关参数的线性关系和所研究值的范围很好(例如:血小板从10到3000 10(9)/l)。白细胞污染低,血小板污染不明显。重复性表现出良好的变异系数。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Evaluation of Cell-Dyn 3500 in extreme values].

The quality tests made during the preparation of labile blood products permit to validate the product and to make sure the making procedures are applied properly. The labile blood products have to correspond to a number of standards set by a ministerial order. It is thus necessary to check the manufacturing unit of some products. On account of the original technology of Cell-Dyn 3500 which associates methods of impedance variation measure analysis and flow cytometric technique analysis on non-marked cells, and of its veterinary modulus permitting counting in extreme values, it seemed to be worth being evaluated in a blood bank quality control laboratory. Linearity was studied from a range of dilutions obtained from high value samples prepared by the centrifugation of blood bags and collection of the buffy coat by Optipress system. The study was performed on 22 samples. The linearity in the counting of red cells, white cells, platelets and haematocrit was measured. Intersample contamination was measured. It focused on the values of platelets and white cells. A sample of high cell concentration prepared in the condition mentioned above and a white cell-reduced blood concentrate were used. The study of repeatability was done by treating 20 times three samples covering a wide range of values of the different parameters of cell numeration. The linearity concerning parameters and the range of the values studied are good (example: from 10 to 3000 10(9)/l for platelets). Contamination is low for white cells and non appreciable for platelets. Repeatability shows excellent variation coefficients.

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