Evaluation of Red Blood Cell Fragment Parameter Detection of Automatic Hematology Analyzer
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摘要:
目的 红细胞碎片（fragmented red cells，FRC）是全自动血液细胞分析仪提供的一项新的检测参数，其与血栓性微血管病等多种疾病密切相关，因此对血液细胞分析仪红细胞碎片的检测性能进行评价。 方法 通过携带污染率、精密度、线性、正确度、灵敏度、特异度等指标，对SYSMEX XN系列全自动血液细胞分析仪红细胞碎片的检测性能进行评价。所有数据采用 SPSS 19.0软件进行分析整理。 结果 SYSMEX XN系列全自动血细胞分析仪检测红细胞碎片的携带污染率为0.11%；批内精密度：各实验浓度下其变异系数（coefficient of variation，CV）分别为8.75%（FRC：42.15×109/L）、6.38%（FRC：83.42×109/L ）、4.57%（FRC：228.74×109/L）、5.31%（FRC：796.89×109/L）；线性验证：线性回归方程为Y = 1.0001X + 9.3288，相关系数为r = 0.9936；正确度验证：以人工镜检为标准，仪器法与其比较，差异无统计学意义（P > 0.05），其相关系数为r = 0.82，灵敏度为92%，特异度为82%。 结论 SYSMEX XN系列全自动血液细胞分析仪检测红细胞碎片快速、简便，携带污染率低，精密度尚佳，线性范围满足要求，与人工镜检法相比具有较好的相关性，特异度和敏感度也较高。血液细胞分析仪可作为外周血红细胞碎片的快速筛查手段，但其检测的精密度仍需进一步提高，且由于方法的局限性，阳性标本需要在显微镜下进行确认。 Abstract:Objective Fragmented red blood cells （FRC） is a new detection parameter provided by the automatic blood cell analyzer, which is closely related to thrombotic microangiopaemia and other diseases. This study is aimed at evaluating the detection performance of automatic hematology analyzer for RBC fragments. Methods The performance of SYSMEX XN series automatic blood cell analyzer was evaluated by carrying contamination rate, precision, linearity, accuracy, sensitivity, specificity and other indicators. All data were analyzed by SPSS 19.0 software. Results The contamination rate of red blood cell fragments detected by SYSMEX XN series automatic hematology analyzer was 0.11%. Intra-batch precision: coefficient of variation （CV） at each experimental concentration were 8.75% （42.15×109/L）, 6.38% （83.42×109/L）, 4.57% （228.74×109/L）, 5.31% （796.89×109/L）. Linear verification: the linear regression equation was Y = 1.0001X + 9.3288, and the correlation coefficient is r = 0.9936., and the correlation coefficient is R =0.9936; Correctness verification: compared with manual microscopy, the was no statistically significant difference(P＞0.05）, the correlation coefficient, sensitivity and specificity were r = 0.82, 92% and 82% respectively. Conclusion SYSMEX XN series automatic blood cell analyzer is quick and easy to operate in detecting red blood cell fragments, with low contamination rate, fair precision and satisfactory linear range. Compared with manual microscopy, it has better correlation, higher specificity and sensitivity. Blood cell analyzer can be used as a rapid screening method for fragments of peripheral blood red blood cells, but the precision of its detection still needs to be further improved, and due to the limitations of the method, positive specimens need to be confirmed under a microscope. -
Key words:
- Erythrocyte fragments /
- Hematology analyzer /
- Performance evaluation
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图 2 仪器法与手工法相关性分析
Figure 2. Correlation analysis between instrumental method and manual method
表 1 标本稳定性实验结果（%）
Table 1. Results of specimen stability （%）
静置
时间浓度1
（CV）浓度2
（CV）浓度3
（CV）浓度4
（CV）30 min 2.8 2.1 2.2 2.4 60 min 3.9 3.8 3.0 4.2 90 min 6.3 6.1 6.0 7.4 120 min 18.4 10.2 14.1 15.2 
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表 2 携带污染率值
Table 2. Results of carrying contamination rate
项目 H1 H2 H3 L1 L2 L3 携带污染率（%） FRC绝对值(×109/L) 726.7 801 836.2 17.7 19.3 18.6 0.11
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表 3 重复性测定结果[（
$ \bar x \pm s $ ），（%）]Table 3. Results of repeatability test[（
$ \bar x \pm s $ ），（%）]组别 FRC绝对值（×109/L） 变异系数CV 浓度1 42.15 ± 3.69 8.75 浓度2 83.42 ± 5.32 6.38 浓度3 228.74 ± 10.45 4.57 浓度4 796.89 ± 58.28 5.31
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表 4 仪器法与人工法的FRC%检测结果
Table 4. FRC% counting results of instrumental method and manual method
方法 人工显微镜镜检法 合计（n） 阳性（n） 阴性（n） 仪器法 阳性（n） 12 7 19 阴性（n） 1 30 31 合计（n） 13 37 50
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