Sysmex XE-2100血细胞分析仪血涂片复检规则的应用研究

Applicated Studies of Blood Slide Review Criteria on Sysmex XE-2100 Hematology Analyzer

目的采用Sysmex XE-2100血细胞分析仪评估国际血液学复检专家组推荐的血细胞复检规则和国内协作组提出的复检规则（简称旧复检规则），通过对实验数据进行分析，提出适合于大型综合医院使用的Sysmex XE-2100血细胞分析仪血涂片新复检规则。方法采用日本希森美康公司生产的XE-2100五分类全自动血细胞分析仪，随机检测患者标本共1486份，同时涂片做显微镜检查，包括细胞形态观察和人工白细胞分类。按照国际血细胞复栓规则、国内协作组复检规则、自行拟定的新筛选方案和涂片镜检阳性标准进行评估，计算出真阳性、假阳性、真阴性、假阴性和涂片复检的比率，并筛选出最佳方案。结果根据国际血液学复检专家组推荐的41条复捡规则和涂片镜检阳性规则对检测结果进行统计分析，真阳性率为14．0％（208／1486），假阳性率为31．49％（468／1486），真阴性率为52．42％（779／1486），假阴性率为2．09％（31／1486）。用旧复检规则和涂片镜检阳性规则对检测结果进行统计分析，真阳性率为12．79％（190／1486），假阳性率为18．98％（282／1486），真阴性率为65．48％（973／1486），假阴性率为2．76％（41／1486）。用修改后的新复检规则（方案4）争镜检阳性规则对1486份标本的数据进行分析，结果显示，真阳性率为13．86％（206／1486），假阳性率为25．17％（374／1486），真阴性率为58．75％（873／1486），假阴性率为2．22％（33／1486）。在新复检规则（方案4）的基础上，参考旧复检规则、XE-2100仪器的性能特点和解放军总医院血细胞分析常规工作情况，提出了适合于大型综合医院使用的XE-2100仪器的血细胞计数和白细胞分类的涂片复检规则；验证试验结果显示，假阴性率0．96％，低于旧复检规则的2．26％，且血液病细胞无漏栓。结论血涂片复检规则在临床应用过程中，应注意收集、整理发现问题，及时对复检规则进行修改和完善，以提高血细胞分析质量和工作效率。

Objective Intend to find out the suitable hematology new review criteria for large scale general hospitals in China via the analysis of experimental data from Sysmex XE-2100 hematology analyzer. Methods The total 1 486 patient samples were respectively detected randomly with the methods of Automated Hematology Analysis on XE-2100 which manufactured by Sysmex Company and microscopy for blood smear detection including observation of cell morphology and manual WBC differential analysis. Ease on hematology review criteria suggested by international consensus group,hematology review criteria suggested by internal consensus group （used review criteria in short）,evaluated according to revised protocol of review program and criteria used to determine a positive smear finding for the study of new review project,calculated true positive, false positive ,true negative ,false negative and the ratio of review quantity,then studied out optimal program. Results According to＂the 41 Items of International Review Rules＂and the microscopic slide review positive rule, the examination results carried on the statistical analysis. The true positive ratio（TP）,the false positive ratio （FN）, the true negative ratio （TN） and the false negative ratio （FN） respectively were 14.0% （208/1 486）, 31.49%（468/1 486）, 52.42% （779/1 486） and 2.09% （31/1 486）. According to＂used review criteria＂and the microscopic slide review positive rule,the examination results carried on the statistical analysis. The TP,FP,TN and FN were 12.79%（190/1 486）, 18.98%（282/1 486）,65.48%（973/1 486） and 2.76%（41/1 486）. The 1486 specimen data were analysied by using＂the revised new review criteria （precept four）＂and slide review positive rule. The TP,FP,TN and FN were 13.86%（206/1 486）,25.17%（374/1 486）,58.75% （873/1 486）and 2.22%（33/1 486） respectively. On the basis of above mentioned. Referring to＂used review criteria＂,the performance and characteristic of XE-2100 and combining with PLA general hospital regular work situation. It was put forward the criteria for slide review following automated CBC and WBC differential analysis in XE-2100 hematology analyzer which was more suitable for large scale general hospitals in China. The retesting resuit demonstrated ：the FN was 0. 96% and less than used review criteria（2.26%）,blasts and immature cells were omitted. Conclusion It is important to summarize the difference between the criteria and practice in clinical settings,and keep on revising and improving the rule constantly,so as to test effectively with higher quality.