对全自动血液分析仪白细胞计数范围复检规则的确立与验证

The establishment and evaluation of white blood cell count for re-examination rules of automatic hematology analyzer

目的确立、验证Sysmex XE-2100全自动血液分析仪(简称XE-2100)白细胞(WBC)高、低值的最佳复检范围。方法将WBC<4.0×109/L及WBC>18×109/L的663例非血液病住院患者的样本分为2组,即高值组和低值组。其中高值组又分为A组(18.00～22.00×109/L,共148份)、B组(22.01～30.00×109/L,共164份);C组(>30.00×109/L,共74份)。低值组分为A'组(1.00～2.00×109/L,共90份);B'组(2.01～3.00×109/L,共92份);C'组(3.01～4.00×109/L,共95份)。对上述各组进行检测分析,以中华人民共和国卫生行业标准——白细胞分类计数参考方法为标准,通过受试者工作特征(ROC)curve曲线找出仪器检测WBC最佳复检范围,并对其进行验证。结果 A组ROC曲线下面积为0.820,当WBC为21.05×109/L时其灵敏度为1.0、特异度为0.536。B组曲线下面积为0.749,C组曲线下面积为0.329。A'组曲线下面积为0.689,B'组曲线下面积为0.825,当WBC为2.45×109/L时其灵敏度为1.0、特异度为0.317。C'组曲线下面积为0.983。验证结果:当WBC在2.45×109/L时无仪器警示标志的共28例,其中2例为假阴性,均为嗜碱粒细胞>2,无重要临床意义;有警示标志的7例,其中1例为假阳性。当WBC为21.0×109/L时无仪器警示标志的共33例,其中只有1例假阴性也是嗜碱粒细胞>2,有警示标志的7例其中3例为假阳性。结论 XE-2100的警示系统可以为复片提供有价值的信息,但血细胞计数范围的高低值也是不容忽略的复检因素。XE-2100在WBC<2.50×109/L及WBC>21.00×109/L时分类误差较大,即便无警示标志的出现依然需进行血细胞显微镜复检,以免造成漏诊。

Objective To establish and validate re-examination optimized range of white blood cell（WBC） high and low values of automatic hematology analyzer Sysmex XE-2100（XE-2100）.Methods 663 samples of WBC 4.0×109/L（low value group） and WBC18×109/L（high value group） were enrolled from routine inpatients without hematology disease.The high value group was further classified into A：18.00-22.00×109/L（n=148）,B：22.01-30.00×109/L（n=164） and C：30.00×109/L（n=74）.The low value group was classified into A＇：1.00-2.00×109/L（n=90）,B＇：2.01-3.00×109/L（n=92） and C＇：3.01-4.00×109/L（n=95）.According to the Sanitary Standard of People＇s Republic of China： the reference methods of WBC differential counting,the receiver operating characteristic（ROC） curve was used to find out an appropriate cut-off value for re-examination,and the value was validated.Results The area under the curve of A group was 0.820,the sensitivity was 1.0,and the specificity was 0.536 at the WBC value = 21.05×109/L.The areas under the curve of B and C groups were 0.749 and 0.329.The areas under the curve of A＇ and B＇ groups were 0.689 and 0.825.The sensitivity was 1.0,and the specificity was 0.317 at the WBC value = 2.45×109/L.The area under the curve of C＇ group was 0.983.The validating results showed that there were 28 samples without showing warning at WBC value = 2.45×109/L,among which 2 cases were false negative and basophilic cells2 without clinical importance.7 samples showed warning,and one of them was false positive.There were 33 samples without showing warning at WBC value = 21.0×109/L,among which 1 was false negative and basophilic cells2.7 samples showed warning,and 3 samples were false positive.Conclusions The warning system of XE-2100 provides useful information for re-examination.The high and low values of WBC counting are the factors for re-examination.The error of WBC classification by instrument is large,when WBC2.50×109/L and WBC21×10.009/L.Microscopic examination even without any warnings is needed.