化学发光法检测血清T-βHCG分析灵敏度验证实验的建立与评价  

Establishment and evaluation of a chemiluminescence method for verifying the sensitivity of serum T-βHCG testing

作　　者：余文辉[1] 张春雷[1] 杨小红[1] 张书楠[1] 候智辉 刘丹瑶[1] 陈甜甜[1] 

机构地区：[1]深圳市中医院检验科,广东深圳518033

出　　处：《中华生物医学工程杂志》2014年第6期441-445,共5页Chinese Journal of Biomedical Engineering

摘　　要：目的对Beckman Couher 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 AccessDXl800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 DX1800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、4．614IU／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0．17IU／L、0．10IU／L、0．5IU／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。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 DXIS00 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.

关 键 词：临床实验室技术 化学发光测定法 绒毛膜促性腺激素 

分 类 号：R730.43[医药卫生—肿瘤]