摘要
目的:对BC-6800Plus全自动血液细胞分析仪的性能进行验证和评价。方法:参照行业标准和仪器说明书要求,对BC-6800Plus全自动血液细胞分析仪的本底计数、携带污染率、精密度、线性范围、不同吸样模式结果可比性、仪器间结果可比性及仪器法和手工镜检法结果可比性进行验证和评价,验证项目包括白细胞(WBC)、红细胞(RBC)、血红蛋白浓度(HGB)、红细胞压积(HCT)、血小板(PLT)、平均红细胞体积(MCV)、平均红细胞血红蛋白含量(MCH)、平均红细胞血红蛋白浓度(MCHC)、网织红细胞百分比(RET%)、有核红细胞百分比(NRBC%)。结果:本底计数和携带污染率符合仪器说明书要求;重复精密度和日间精密度的变异系数均在允许范围内;线性范围验证,斜率均在1±0.02范围内,r2≥0.997;2种吸样模式结果具有可比性;以Sysmex XE-2100全自动血液分析仪为基准的仪器间结果可比性验证,相对偏差达标率均大于80%;RET%仪器法和手工镜检法相关性分析,y=1.054x+0.313,r=0.965,P<0.001,结果具有可比性;NRBC%仪器法和手工镜检法相关性分析,y=0.981x-0.022,r=0.985,P<0.001,结果具有可比性。结论:BC-6800Plus全自动血液细胞分析仪性能良好、结果准确可靠,符合临床使用要求。
Objective To validate and evaluate the analytical performance of BC-6800Plus auto hematology analyzer.Methods The background count,carry-over rate,precision,linear range,comparability of the results between different aspirate modes,comparability of the results between instruments and comparability of the results between instrumental and manual methods were verified and evaluated with reference to industry standards and instrument manual requirements,and the items involved in WBC,RBC,HGB,HCT,PLT,MCV,MCH,MCHC,RET%and NRBC%.Results The coefficients of variation of repeatability and day-to-day precision were both restrained within the allowable ranges;the slope of the linear range verification was within the range of 1±0.02,r2≥0.997;the results of the two sampling modes were comparable;the relative deviations of the accuracy verification based on Sysmex XE-2100 fully automatic hematology analyzer were all greater than 80%;the instrument and manual methods proved their comparability in RET%(y=1.054x+0.313,r=0.965,P<0.001 and NRBC%(y=0.981x-0.022,r=0.985,P<0.001).Conclusion BC-6800Plus auto hematology analyzer gains advantages in performances,accuracy and reliability,and thus is worthy for clinical application.[Chinese Medical Equipment Journal,2020,41(10):37-42]
作者
邓兴
龚春梅
邓少丽
DENG Xing;GONG Chun-mei;DENG Shao-li(Department of Laboratory Medicine,Daping Hospital,Army Medical University,Chongqing 400042,China)
出处
《医疗卫生装备》
CAS
2020年第10期37-42,共6页
Chinese Medical Equipment Journal
基金
陆军军医大学大坪医院“1135”优秀人才工程基金项目。
