未成熟血小板的性能评价及在血小板减少性疾病中的应用  

Performance evaluation of the immature platelet fraction and its application in thrombocytopenic diseases

作　　者：邱凯[1] 刘志伟[1] 黄丽春[1] 孙德华[1] 

机构地区：[1]南方医科大学南方医院检验科,广州510515

出　　处：《检验医学与临床》2018年第1期47-50,共4页Laboratory Medicine and Clinic

摘　　要：目的应用Sysmex XN-20全自动血细胞分析仪检测外周血中的未成熟血小板分数(IPF%)和未成熟血小板绝对值(IPF#),对其进行性能评价和建立参考区间,探讨其在血小板减少性疾病中的应用价值。方法对该分析仪检测IPF%和IPF#进行性能评价包括精密度、稳定性、携带污染和线性范围,并与Sysmex XE-5000检测IPF%和IPF#进行相关性研究。检测240例健康人建立参考区间,设立为健康对照组;选择111例血小板减少性疾病患者作为疾病组;特发性血小板减少性紫癜(ITP)组与健康对照组绘制IPF%的受试者工作特征曲线。结果该血细胞分析仪检测IPF%和IPF#的批内精密度正常、高值的变异系数(CV)分别是2.52%、2.32%和3.60%、1.93%,批间CV为1.8%和3.7%;正常值、高值的IPF%和IPF#在24h内CV分别为8.4%、8.8%和4.4%、4.5%;IPF%携带污染率为0.16%,IPF#携带污染率为0.27%;IPF#在(0~94.8)×109/L成线性,与Sysmex XE-5000检测IPF%和IPF#无相关性(P>0.05);不同性别组之间差异无统计学意义(P>0.05),参考范围IPF%:0.9%~4.5%,IPF#:(3.7~9.7)×109/L;ITP组、骨髓增生异常综合征(MDS)组与健康对照组相比较,IPF%差异均有统计学意义(P<0.05);再生障碍性贫血(AA)、急性淋巴细胞白血病(ALL)、急性非淋巴细胞白血病(AML)与健康对照组相比较,IPF#差异有统计学意义(P<0.05);IPF%最佳临界值为11.6%,该点灵敏度100%,特异度100%。结论应用Sysmex XN-20全自动血细胞分析仪检测IPF%和IPF#精密度高、稳定性好、携带污染率极低、IPF#线性范围宽广,满足临床检测需求,对血小板减少性疾病临床诊断、鉴别诊断和预后有一定临床应用价值。Objective Using Sysmex XN-20 automatic hematology analyzer to detect the percentage of immature platelet fraction(IPF%)and the absolute number of immature platelet(IPF#)in the peripheral blood,to evaluate the performance of the IPF% and IPF# and establish a reference interval,to investigate the clinical significance in the thrombocytopenic diseases.Methods The performance of the analyzer for detecting IPF% and IPF# was evaluated,including precision,stability,carryover and the linear range,and correlated with Sysmex XE-5000 detection of IPF%and IPF#.In this research,240 normal samples were used to form a reference interval and set for negative control group.111 samples of the thrombocytopenic diseases were selected as positive group;Receiver operating characteristic curve between the ITP group and the healthy control group was drawed.Results The within-batch precisions of IPF% and IPF#for normal-level,high-level were2.52%,2.32%and 3.60%,1.93%,the between-batch precisions were 1.8%and 3.7%;the stability of IPF%and IPF# for normal-level were 8.4%,8.8% within 24 hours,the high-level were 4.4%,4.5% within 24 hours;the carryover of IPF% was 0.16%,the carryover of IPF# was 0.27%;a linear relation of IPF# was observed from 0 to 94.8×109/L,which had no statistical difference with Sysmex XE-5000(P>0.05).No statistical difference was observed within gender(P>0.05),and the reference interval was determined as IPF%0.9%-4.5% and IPF#(3.7-9.7)×109/L.In idiopathic thrombocytopenic purpura(ITP)group and myelodysplastic syndrome(MDS)group,IPF% had statistical significance compared with healthy control group(P<0.05);In aplastic anemia(AA),acute lymphoblastic leukemia(ALL)and acute nonlymphocytic leukemia(AML)group,IPF# had statistical significance compared with healthy control group(P<0.05).The IPF%cut-off for a diagnosis of ITP was 11.6%,the sensitivity was 100% and specificity was 100%.ConclusionThe determination of IPF%and IPF# by the Sysmex XN-20 have high precision,good stability,very low carryover and good linear range of t

关 键 词：SYSMEX XN-20全自动血细胞分析仪 未成熟血小板 血小板减少性疾病 

分 类 号：R446.1[医药卫生—诊断学]