国际血细胞复检规则在贝克曼-库尔特系列血细胞分析仪上的应用及改进方案

目的 采用贝克曼.库尔特系列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,通过对实验数据进行分析建立适合于中国人群使用的血细胞复检规则.方法 3家医院分别采用美国贝克曼.库尔特公司生产的MAXM、GENS和LH750五分群(类)全自动血细胞分析仪随机检测患者标本共3 600份,同时涂片做显微镜检查,包括人工白细胞分类和细胞形态观察.按照国际血细胞复检规则和涂片镜检阳性规则进行评估,计算出真阳性、真阴性、假阳性和假阴性的比率.通过分析假阳性和假阴性的原因,并结合中国人群和临床检验的实际情况,对国际复检规则进行修改,制定出适合于中国人群使用的血细胞复检规则.然后检测240份患者标本对新规则进行验证.结果 根据国际血液学复检专家组推荐的41条复检规则和涂片镜检阳性规则对检测结果进行统计学分析,真阳性率为4.9%(177/3 600);假阳性率为24.2%(870/3 600);假阴性率为0.5%(19/3 600);真阴性率为70.4%(2 534/3 600).由于中国人群血细胞正常参考范围不同于西方人群,通过对数据进行分析,并根据我国的常规工作情况,将国际复检规则修改为23条;将镜检阳性规则中添加了白细胞分类比率4条规则.采用修改后的复检规则和镜检阳性规则评估结果,真阳性率为9.9%(355/3 600);假阳性率为17.1%(617/3 600);假阴性率为1.8%(65/3 600);真阴性率为71.2%(2 563/3 600).采用前后两个复检规则均未漏检原幼细胞,修改后假阴性率略高,是由于镜检阳性规则中增加了白细胞分类比率所致.验证实验结果表明:真阳性率为13.7%(33/240);假阳性率为15.8%(38/240);假阴性率为2.5%(6/240);真阴性率为68.0%(163/240).结论 国际血液学复检专家组推荐的血细胞复检规则虽有重要临床参考价值,但在中国人群中使用却增加了假阳性率.本研究制定出的贝克曼-库尔特系列血细胞分析仪的血细胞复检规则更符合中国人群特征.

Applications of international blood smear review criteria for improvement on Beckman-Coulter hematology analyzers

Objective To evaluate the international blood smear review criteria for improvement using Beckman-Coulter hematology analyzers and find out proper slide review criteria suitable for Chinese population. Methods 3 600 random-selected blood samples were tested in three hospitals using MAXM, GENS and LH750 5-diff automated analyzers and a manual differential with a smear review was performed on all samples in the study. True positive rate, true negative rate, false positive rate and false negative rate were calculated according to the international blood smear review criteria. We have set up smear review criteria for Chinese population by analyzing false positive and false negative cases according to Chinese clinical conditions. Another 240 blood samples were tested in three hospitals using the same analyzers to verify the new slide review rules. Results According to international blood smear criteria, the true positive rate was 4.9%, false positive rate was 24.2%, true negative rate was 70.4% and false negative rate was 0.5%. The international smear review criteria were modified into 23 criteria by analysis of above statistical data. In addition, we added four WBC differential ratio rules in positive smear criteria. After modification, the true positive rate was 9.9% (355/3 600) ,false positive rate was 17.1% (617/3 600), true negative rate was 71.2 % (2 563/3 600) and false negative rate was 1.8% (65/3 600). No blast cell was missed using both smear review criteria. A little higher false negative rate after modification was caused by supplemented differential ratio roles in positive smear criteria. Verification results were satisfactory;The tree positive rate was 13.7% (33/240) ;false positive rate was 15.8% (38/240) ;false negative rate was 2.5% (6/240) and true negative rate was 68.0% (163/240). Conclusions Although the smear review criteria suggested by the International Consensus Group is clinically important, the false positive rate increases when they are used in Chinese population. The modified slide review criteria used on Beckman-Coulter hematology analyzers in this study are more suitable for Chinese laboratories.