中国医师杂志
中國醫師雜誌
중국의사잡지
JOURNAL OF CHINESE PHYSICIAN
2014年
10期
1364-1369
,共6页
血细胞计数/仪器和设备%自动分析/仪器和设备%血液化学分析
血細胞計數/儀器和設備%自動分析/儀器和設備%血液化學分析
혈세포계수/의기화설비%자동분석/의기화설비%혈액화학분석
Blood cell count/instrumentation%Autoanalysis/instrumentation%Blood chemical analysis
目的 验证Beckman Coulter ACT-5DIFF AL全自动五分类血细胞分析仪性能是否满足临床要求.方法 对该检测系统的携带污染率、正确度、精密度、不确定度、分析测量范围、参考区间、进样模式等指标进行性能评价.结果 各参数携带污染率均为0.18％;根据卫生部临检中心血细胞正确度验证结果回报,与靶值比较,偏倚在0.32％ ～2.29％范围内;各参数不同浓度的实验室变异系数即精密度在0.35％～4.46％范围之内,均＜1/3 CLIA'88能力验证分析质量要求.各参数的扩展不确定度分别为UwBC低=7.4％,UwBC高=3.8％,URBC低=3.4％,URBC高=2.8％,UHGB低=3.9％,UHGB高=2.2％,UPLT低=9.8％,UPLT高=7.6％,UMCv低=2.6％,UMCv高=2.5％.分析测量范围较广:白细胞(WBC)在(0.2～137.3)×109/L内,红细胞(RBC)在(0.72～7.66)×1012/L内,血红蛋白(HGB)在20～231 g/L内,血小板(PLT)在(25 ～983)×109/L内,红细胞比积(HCT)在6.1％ ～68.0％内呈线性,各参数线性回归的相关系数接近1.0;引用的参考区间合适;自动与手动进样模式检测结果无明显差异;白细胞五分类验证合格.结论 ACT-5 DIFF AL全自动血细胞分析仪,在室内质控通过的情况下,各性能指标基本达到实验室质量要求,并能较好的满足临床需求.
目的 驗證Beckman Coulter ACT-5DIFF AL全自動五分類血細胞分析儀性能是否滿足臨床要求.方法 對該檢測繫統的攜帶汙染率、正確度、精密度、不確定度、分析測量範圍、參攷區間、進樣模式等指標進行性能評價.結果 各參數攜帶汙染率均為0.18％;根據衛生部臨檢中心血細胞正確度驗證結果迴報,與靶值比較,偏倚在0.32％ ～2.29％範圍內;各參數不同濃度的實驗室變異繫數即精密度在0.35％～4.46％範圍之內,均＜1/3 CLIA'88能力驗證分析質量要求.各參數的擴展不確定度分彆為UwBC低=7.4％,UwBC高=3.8％,URBC低=3.4％,URBC高=2.8％,UHGB低=3.9％,UHGB高=2.2％,UPLT低=9.8％,UPLT高=7.6％,UMCv低=2.6％,UMCv高=2.5％.分析測量範圍較廣:白細胞(WBC)在(0.2～137.3)×109/L內,紅細胞(RBC)在(0.72～7.66)×1012/L內,血紅蛋白(HGB)在20～231 g/L內,血小闆(PLT)在(25 ～983)×109/L內,紅細胞比積(HCT)在6.1％ ～68.0％內呈線性,各參數線性迴歸的相關繫數接近1.0;引用的參攷區間閤適;自動與手動進樣模式檢測結果無明顯差異;白細胞五分類驗證閤格.結論 ACT-5 DIFF AL全自動血細胞分析儀,在室內質控通過的情況下,各性能指標基本達到實驗室質量要求,併能較好的滿足臨床需求.
목적 험증Beckman Coulter ACT-5DIFF AL전자동오분류혈세포분석의성능시부만족림상요구.방법 대해검측계통적휴대오염솔、정학도、정밀도、불학정도、분석측량범위、삼고구간、진양모식등지표진행성능평개.결과 각삼수휴대오염솔균위0.18％;근거위생부림검중심혈세포정학도험증결과회보,여파치비교,편의재0.32％ ～2.29％범위내;각삼수불동농도적실험실변이계수즉정밀도재0.35％～4.46％범위지내,균＜1/3 CLIA'88능력험증분석질량요구.각삼수적확전불학정도분별위UwBC저=7.4％,UwBC고=3.8％,URBC저=3.4％,URBC고=2.8％,UHGB저=3.9％,UHGB고=2.2％,UPLT저=9.8％,UPLT고=7.6％,UMCv저=2.6％,UMCv고=2.5％.분석측량범위교엄:백세포(WBC)재(0.2～137.3)×109/L내,홍세포(RBC)재(0.72～7.66)×1012/L내,혈홍단백(HGB)재20～231 g/L내,혈소판(PLT)재(25 ～983)×109/L내,홍세포비적(HCT)재6.1％ ～68.0％내정선성,각삼수선성회귀적상관계수접근1.0;인용적삼고구간합괄;자동여수동진양모식검측결과무명현차이;백세포오분류험증합격.결론 ACT-5 DIFF AL전자동혈세포분석의,재실내질공통과적정황하,각성능지표기본체도실험실질량요구,병능교호적만족림상수구.
Objective To evaluate the performance of the Beckman Coulter ACT-5DIFF AL automated hematology analyzer and to verify whether it meets the clinical requirement.Methods The residual contamination rate,accuracy,precision,uncertainty,measurement range,reference interval,and sample injection pattern of detecting system were evaluated.Results The residual contamination of each parameter was less than or equal to 0.18％.According to room between qualitative evaluation results,compared to the target value,bias ranged from 0.32％ to 2.29％.Different concentrations of laboratory variation coefficient (namely precision) of each parameter ranged from 0.35％ to 4.46％,and both of which were less than a third of the CLIA'88 ability verification analysis quality requirements.The expanded uncertainty of each parameter was Uwhite blood cell (WBC) low =7.4％,UWBC high =3.8％,Ured blood cell (RBC) low =3.4 ％,U RBC high =2.8 ％,Uhemoglobin (HGB) low =3.9 ％,UHGB high =2.2 ％,Uplatelet (PLT) low =9.8 ％,UPLT high =7.6％,UMCV low =2.6％,and UMCV high =2.5％.Analysis had a wide measuring range:WBC (0.2 ～ 137.3) × 109/L,RBC(0.72 ～ 7.66) × 1012/L,HGB (20 ～ 231)g/L,PLT(25 ～983) × 109/L,and hematocrit (HCT) (6.1 ～68.0)％.All of them had a linear relationship,and the correlation coefficient of linear regression was close to 1.0.The reference interval quoted was suitable.Both of the automatic and the hand sample injection pattern had no significantly difference in result detection.Five categories of WBC were verified up to standard.Conclusions Under the circumstance of indoor quality control approved,each performance indicator approximately reached the laboratory quality requirements,and it also met the clinical requirements.
