化学发光检测血清总人绒毛膜促性腺激素分析测量范围和临床可报告范围的建立

Investigation of the analytical measurement range and clinical reportable range of chemiluminescence immunoassay in the detection of THCG

目的验证西门子Centaur cp化学发光检测系统检测总人绒毛膜促性腺激素(THCG)的分析测量范围(AMR),并建立临床可报告范围(CRR)。方法参考美国临床与实验室标准化协会(CLSI)EP6-A文件和相关文献,选用超出厂商声明的分析测量范围下限和上限浓度的样本,按比例精确配成等间距的不同浓度样本,每个浓度样本重复测定2次,用多项式回归评价并验证厂商声明AMR;选用THCG浓度在分析测量范围内的高值样本3份,用稀释液作不同倍数稀释后测定,计算稀释回收率,确定最大允许稀释度,并结合功能灵敏度建立CRR。结果THCG的分析测量范围:1.7～995.0mIU/mL,最大允许稀释度1∶200,根据其功能灵敏度,临床可报告范围:2.6～199 000mIU/mL。结论西门子Centaur cp化学发光检测系统在厂商声明的分析测量范围内线性良好,所建立的临床可报告范围可以满足临床需要。

Objective To investigate the analytical measurement range（AMR） and establish the clinical re- portable range（CRR） of SIEMENS Centaur cp system in the detection of THCG. Methods Samples with equal inter- val,proportional prepared with samples at eoncent ration levels, exceeding the low and high coneent ration limits claimed by manufacture,were detected twice each. The AMR claimed by manufacture was evaluated and verified by polynomial regression analysis. Three samples,at high concentration level and within the AMR, diluted to different dilution ratio, were detected, and the dilution recovery rate was calculated to determine the max allowable dilution rate and establish CRR by combining functional sensitivity. All of the detection and analysis mentioned above were per formed according to clinical and laboratory standard institute（CLSI） document EP6-A. Results The AMR of THCG was 1.7--995.0 mlU/mI.,the max allowable dilution rate was 1 .＂ 200,the CRR was 2.6--199 000 mIU/mL. Conclu- sion There can be fine linearity within the AMR,claimed by manufacture. SIEMENS Centaur cp system in the de- tection of THCG and the CRR established in this research can meet the needs of clinical laboratory.