CAJ | 학술논문

目的对Beckman Coulter Access DXI800化学发光免疫分析仪检测血清总人绒毛膜促性腺激素(T-βHCG)的分析灵敏度进行验证与评价.方法参照美国临床实验室标准化协会(CLSI) EP17-A文件,首先对Beckman Coulter Access DXI800系统进行精密度和准确度验证试验,再将空白样品和低浓度系列样品在该化学发光免疫分析仪上进行检测,记录血清T-βHCG值和相对发光单位(relative light units,RLU),依据数据的分布规律,采用相应的统计学方法确定血清T-βHCG的检测低限(LLD)、生物检测限(BLD)、功能灵敏度(FS).结果空白样品T-βHCG测定的RLU值的均值为10 224.18,标准差为400.85.Beckman Coulter Access DXI800系统精密度和准确度符合CLIA'88规定的性能要求.低值系列样品T-βHCG测定结果均值分别为0.015、0.109、0.507、1.060、2.418、4.614 IU/L;其RLU的日间CV%值分别为2.76、3.00、6.62、4.31、3.00、2.84.血清T-βHCG检测低限、生物检测限、功能灵敏度分别为0.17 IU/L、0.10 IU/L、0.5 IU/L,结果均优于厂家声明的分析性能.结论该检测系统检测血清T-βHCG的分析灵敏度符合临床要求,验证方案和实验方法简便,实用和可行.
목적 대Beckman Coulter Access DXI800화학발광면역분석의검측혈청총인융모막촉성선격소(T-βHCG)적분석령민도진행험증여평개.방법 삼조미국림상실험실표준화협회(CLSI) EP17-A문건,수선대Beckman Coulter Access DXI800계통진행정밀도화준학도험증시험,재장공백양품화저농도계렬양품재해화학발광면역분석의상진행검측,기록혈청T-βHCG치화상대발광단위(relative light units,RLU),의거수거적분포규률,채용상응적통계학방법학정혈청T-βHCG적검측저한(LLD)、생물검측한(BLD)、공능령민도(FS).결과 공백양품T-βHCG측정적RLU치적균치위10 224.18,표준차위400.85.Beckman Coulter Access DXI800계통정밀도화준학도부합CLIA'88규정적성능요구.저치계렬양품T-βHCG측정결과균치분별위0.015、0.109、0.507、1.060、2.418、4.614 IU/L;기RLU적일간CV%치분별위2.76、3.00、6.62、4.31、3.00、2.84.혈청T-βHCG검측저한、생물검측한、공능령민도분별위0.17 IU/L、0.10 IU/L、0.5 IU/L,결과균우우엄가성명적분석성능.결론 해검측계통검측혈청T-βHCG적분석령민도부합림상요구,험증방안화실험방법간편,실용화가행.
Objective To verify and evaluate the sensitivity of serum total-β human chorionic gonadotropin (T-βHCG) test with Beckman Coulter Access DXI800 chemiluminescence immunoassay analyzer.Methods Firstly,the precision and accuracy of Beckman Coulter Access DXI800 system was examined by verification test,with reference to the Clinical Laboratory Standards Institute(CLSI)EP17-A documents.Then,blank and low-concentration samples were tested by the chemiluminescence immunoassay analyzer.The value of serum T-βHCG and the relative light units(RLU)were recorded.The lower limit of detection(LLD),biological detection limit(BLD)and functional sensitivity(FS)of serum T-βHCG were determined by using appropriate statistical methods based on the data distribution.Results The mean RLU of blank samples for T-βHCG detection was 10 224.18 (standard deviation:400.85).The precision and accuracy of Beckman Coulter Access DXI800 system met the performance requirements of CLIA'88 regulations.The mean T-βHCG levels in a series of lower concentration samples were 0.015,0.109,0.507,1.060,2.418,and 4.614 IU/L respectively;and the inter-day CV%of their RLU values were 2.76,3.00,6.62,4.31,3.00,and 2.84 respectively.The LLD,BLD and FS of serum T-βHCG was 0.17 IU/L,0.10 IU/L and 0.50 IU/L,respectively.All the results were superior to the analytical performance declared by the manufacturer.Conclusions The analytical sensitivity of Beckman Coulter Access DXI800 system for serum T-βHCG detection is consistent with clinical requirements.The verification protocol and experimental method are simple,practical and feasible.