van der Meer Pieter F, Dijkstra-Tiekstra Margriet J, Mahon Anne, de Wildt-Eggen Janny
Sanquin Blood Bank North West Region, Amsterdam, The Netherlands.
Transfusion. 2009 Jan;49(1):81-90. doi: 10.1111/j.1537-2995.2008.01930.x. Epub 2008 Oct 2.
Hematology analyzers are designed to count whole blood samples, but are also used by blood centers to perform quality control on blood components. In platelet (PLT) concentrates, the number of PLTs is approximately fivefold higher and red blood cells are absent, causing variable PLT counting results. It was our aim to compare currently used hematology analyzers for counting PLTs in PLT concentrates using fixed human PLTs.
PLT samples were fixed, diluted into seven concentration levels (plus one blank), aliquoted, and shipped to 68 centers. Evaluable data were obtained for 89 hematology analyzers. All samples were counted six times, and results were reported to the coordinating center. The overall group mean was calculated, and the percentage deviation from this mean was calculated for each analyzer.
At PLT levels relevant for blood centers, 750 x 10(9) to 2000 x 10(9) per L, analyzers gave results that were between 35 percent lower and 16 percent higher than the overall group mean. Within a group of analyzers, results were comparable with coefficient of variations usually below 10 percent, indicating that the observed differences were caused by instrument characteristics. A smaller study with fresh, unfixed PLT samples showed that analyzers behaved similarly for fixed and fresh PLTs.
With a wide array of currently used hematology analyzers, a marked difference was determined for the PLT counts of fixed human-based identical samples provided to 68 laboratories by a centralized facility. A gold standard method is needed to allow for more valid interlaboratory comparisons between hematology analyzers.
血液分析仪旨在对全血样本进行计数,但血液中心也使用它们对血液成分进行质量控制。在血小板(PLT)浓缩物中,PLT数量大约高五倍且不存在红细胞,这会导致PLT计数结果出现差异。我们的目的是使用固定的人PLT来比较目前用于计数PLT浓缩物中PLT的血液分析仪。
将PLT样本固定,稀释至七个浓度水平(加一个空白样本),分装后运至68个中心。获得了89台血液分析仪的可评估数据。所有样本均计数六次,并将结果报告给协调中心。计算总体组均值,并计算每台分析仪相对于该均值的偏差百分比。
在与血液中心相关的PLT水平,即每升750×10⁹至2000×10⁹时,分析仪给出的结果比总体组均值低35%至高16%。在一组分析仪中,结果具有可比性,变异系数通常低于10%,这表明观察到的差异是由仪器特性引起的。一项针对新鲜、未固定PLT样本的较小规模研究表明,分析仪对固定和新鲜PLT的表现相似。
对于由一个集中机构提供给68个实验室的基于固定人源的相同样本的PLT计数,目前使用的众多血液分析仪之间存在显著差异。需要一种金标准方法来实现血液分析仪之间更有效的实验室间比较。