综合评价Sysmex XT-2000i全自动血细胞分析仪五项主要指标性能

Comprehensive evaluation of five major indexes of XT-2000i Sysmex automated hematology analyzer

目的综合评价希森美康(XT-2000i)全自动血细胞分析仪五项主要检测指标性能。方法对XT-2000i全自动血细胞分析仪主要检测指标白细胞(WBC)、红细胞(RBC)、血红蛋白(HGB)、红细胞压积(Hct)和血小板(PLT)等五项的空白计数、精密度、携带污染率、线性范围、准确度以及仪器间比对和WBC分类相关性等项目进行综合评价。结果 XT-2000i五项主要指标的空白计数符合厂家规定标准要求,批内精密度满足1/4美国临床检验修正法规(CLIA,88)标准要求,批间精密度满足1/3CLIA,88标准要求,携带污染率符合国际血液学标准化委员会(ICSH)规定<1.00%标准的要求,线性相关性良好(r≥0.995),准确度和仪器间偏差百分比均满足WS/T 406-2012标准要求,白细胞分类结果与人工镜检结果相关性较好。结论希森美康XT-2000i全自动血细胞分析仪的五项主要指标性能良好,测定数据准确可靠,能满足临床血液分析快速筛查需要。能为疾病诊断、治疗和疗效观察提供真实、准确、可靠的依据。

Objective Comprehensive evaluation of Sysmex（XT-2000i）automatic blood cell analyzer five main performance index.Methods On XT-2000 ifull automatic blood cell analyzer to measure white blood cell（WBC）,red blood cell（RBC）,hemoglobin（HGB）,red blood cell hematocrit（HCT）and platelet（PLT）,five items such as blank count,precision,contamination rate,linear range,accuracy,and correlation between the WBC classification and so on were evaluated comprehensively.Results XT-2000 ifive main targets of blank count in accordance with the manufacturers standard requirements,within batch precision meet 1/4 USA clinical testing correction（CLIA,88）standards,inter batch precision satisfies 1/3CLIA,88 standard requirements,carryover in line with international hematology Standard Committee（ICSH）provisions1.00% standard requirements,the linear correlation between good（r≥0.995）,the error percentage of accuracy and precision meet the WS/T 406-2012 standard requirements,the white blood cell classification results and artificial lens check result correlation better.Conclusion Sysmex XT-2000 iautomatic blood cell analyzer of the five major indicators of good performance,accurate and reliable data,can meet the clinical blood analysis rapid screening needs.It can provide real,accurate and reliable basis for the diagnosis,treatment and observation of the disease.