摘要
目的评价BECKMAN DXI800化学发光检测系统检测血清雌二醇(E2)的可报告范围。方法参考美国临床和实验室标准研究院(CLSI)EP6-A2文件和相关文献,在BECKMAN DXI800化学发光检测系统上进行E2的方法可报告范围实验、功能灵敏度实验以及最大稀释度实验,从而建立E2的临床可报告范围。结果所有实验数据均符合所设置要求,E2的检测在分析测量范围0 pg/m^4680 pg/ml内呈线性(r=0.999),与厂商声明基本一致;功能灵敏度为16.85 pg/ml,最大稀释度为8倍,临床可报告范围为16.85 pg/ml^37440 pg/ml。结论选用的可报告范围评价方案及提出的实验建议具有很强的操作性和实用性。
Objective To evaluate the reportable range of BECKMAN DXI800 chemiluminescence immunoassay system in serum estradiol（ E2） detection. Methods Referring to clinical and laboratory standards institute（ CLSI） EP6-A2 evaluation protocols and pertinent literatures,the analytical measurement range（ AMR）,functional sensitivity and maximum dilution limit of BECKMAN DXI800 chemiluminescence immunoassay system in estradiol detection were tested to establish the clinical reportable range（ CRR） of estradiol. Results All the experimental data were in line with the setting requirements. E2 showed good linearity in AMR of 0 pg / ml - 4680 pg / ml（ r = 0. 999）,according with the declaration of the manufacturer. The functional sensitivity was 16. 85 pg / ml,the maximum dilution limit was 8 times,and the CRR of E2 was 16. 85 pg / ml - 37440 pg / ml. Conclusion The experimental projects and proposes for evaluation of E2 reportable range show good maneuverability and practicability.
出处
《中国卫生检验杂志》
北大核心
2014年第7期967-969,共3页
Chinese Journal of Health Laboratory Technology
关键词
化学发光检测
雌二醇
分析测量范围
临床可报告范围
Chemiluminescence immunoassay
Estradiol
Analytical measurement range
Clinical reportable range
