共识方法在流式细胞术中小和小发作性夜间血红蛋白尿克隆检测中的性能特征。
Performance characteristics of consensus approaches for small and minor paroxysmal nocturnal hemoglobinuria clone determination by flow cytometry.
出版信息
Clin Chem Lab Med. 2013 Nov;51(11):2133-9. doi: 10.1515/cclm-2013-0251.
BACKGROUND
Evaluation of paroxysmal nocturnal hemoglobinuria (PNH) clones by flow cytometry (FCM) is not standardized and is associated with consistent inter-laboratory variability.
METHODS
In order to rule out the influence of particular approach in generating final results, we analyzed the performance characteristics of individual consensus strategies for small to intermediate (1%-20%) and minor (<1%) PNH clones within the white blood cell (WBC) and red blood cell (RBC) compartments with sensitivity up to 0.1%.
RESULTS
Coefficient of variation (CV) for precision/reproducibility analysis ranged from 0.67%/1.49% to 2.56%/3.09% for granulocytes, from 0.93%/3.09% to 7.76%/12.06% for monocytes and from 0.41%/4.73% to 6.53%/5.1% for RBCs. Coefficient of determination (r2) for linear regression analysis ranged from 0.95 to 0.99, Wilcoxon ranks test showed no statistically significant differences (p>0.05), Bland-Altman analysis demonstrated performance agreement with mean bias ranging from -0.18 to 1.24.
CONCLUSIONS
Our results confirmed very good performance characteristics for precision and reproducibility analysis, excellent correlation and favorable agreement between strategies, suggesting that reported inter-laboratory variability is related mainly to incorrect performance and/or insufficient experience with PNH testing by flow cytometry, rather than to relevant limitations of any particular approach.
背景
流式细胞术（FCM）评估阵发性睡眠性血红蛋白尿症（PNH）克隆尚未标准化，且与实验室间始终存在的可变性相关。
方法
为了排除特定方法在生成最终结果时的影响，我们分析了在白细胞（WBC）和红细胞（RBC）部分内，对于小至中等（1%-20%）和较小（<1%）PNH 克隆的个体共识策略的性能特征，其灵敏度高达 0.1%。
结果
精密度/可重复性分析的变异系数（CV）在粒细胞中范围为 0.67%/1.49%至 2.56%/3.09%，在单核细胞中范围为 0.93%/3.09%至 7.76%/12.06%，在 RBC 中范围为 0.41%/4.73%至 6.53%/5.1%。线性回归分析的决定系数（r2）范围为 0.95 至 0.99，Wilcoxon 秩检验无统计学差异（p>0.05），Bland-Altman 分析表明与平均偏差范围为-0.18 至 1.24 的性能一致。
结论
我们的结果证实了精密度和可重复性分析的非常好的性能特征，策略之间具有极好的相关性和良好的一致性，这表明报告的实验室间可变性主要与流式细胞术检测 PNH 的不正确性能和/或经验不足有关，而不是与任何特定方法的相关限制有关。
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