Masse M
Centre Régional de Transfusion Sanguine, Besançon.
Transfus Clin Biol. 1995;2(5):365-72. doi: 10.1016/s1246-7820(05)80080-1.
The precise measurement of low numbers of leukocyte below 0.1 WBC/microliter in filtered red cell or platelet suspensions meet both aims: to check the compliance with previously determined requirements and to evaluate the performances of novel filtering material (5 log depletion or more), justified by more and more important clinical use. The reliability of results, obtained with the chosen method, is ensured by applying of validation protocol, including training of technologist, assessment of the analytical range and the detection limit, assessment of precision and accuracy. The flow cytometry (FC) and Nageotte Chamber (NC) method are the both techniques which are currently used in routine Quality Control (QC) and validated by multicenter studies. Recent developments are made for increasing the sensibility of these counting methods, thanks to higher concentration or volume of the sample to be analysed. Among the experimental techniques, requiring more advances before implementing in QC program, quantitative PCR must become essential as reference method for evaluating the efficiency of filtration, in the future.
精确测量过滤后的红细胞或血小板悬液中白细胞数量低于0.1×10⁹/L的低数值，可实现两个目标：检查是否符合先前确定的要求，以及评估新型过滤材料（5 log或更高的清除率）的性能，这种材料因临床应用日益重要而具有合理性。通过应用验证方案确保所选方法获得结果的可靠性，验证方案包括对技术人员的培训、分析范围和检测限的评估、精密度和准确度的评估。流式细胞术（FC）和纳盖奥特计数板（NC）方法是目前用于常规质量控制（QC）且经多中心研究验证的两种技术。由于待分析样品的浓度或体积更高，最近在提高这些计数方法的灵敏度方面取得了进展。在QC程序中实施之前需要更多进展的实验技术中，定量PCR未来必须成为评估过滤效率的重要参考方法。
