磁分离酶联免疫测定男性生殖激素方法性能评价

Methodlogical Evaluation in Determinating Man Hormones Using Magnetism Immunoassay

目的 :对磁分离酶联免疫测定 (MAIA)法测定男性生殖激素的方法学性能作临床和实验室评价。方法 :将本法与放射免疫测定 (RIA)法进行对比研究。结果 :MAIA法测定促卵泡生成激素 (FSH)、促黄体生成素 (LH)、睾酮 (T)和催乳素 (PRL)的线性分别为 0～ 15 0IU L、0～ 2 0 0IU L、0 .5～ 5 5ng L、0～ 2 5 0ng L ;最小检测量分别为 0 .3mIU ml、0 .2 5mIU ml、4 μIU ml、4 μIU ml;批内CV <4 % ,批间CV <8% ,平均回收率偏差 <5 % ,互感率 <3% ;与RIA法比较 ,两法相关系数分别为 0 .982 6、0 .85 5 0、0 .85 12、0 .9831。临床质控观察 6 0d ,质控稳定 ;成年健康男性 (n =95 )血清FSH、LH、T、PRL的参考范围分别为 :0 .2 5～ 10 .18IU L、0 .33～ 8.95IU L、0 .5 4～ 11.11ng L和 8.77～ 33.4 3ng L。结论 :用MAIA法测定男性生殖激素 ,方法灵敏 ,结果可靠 ,符合临床要求。

Objective:To use magnetisim immunoassay (MAIA) to determine man hormones and evaluate its performance. Method:Correlation investigation between MAIA and radioimmunoassay was done. Results:We employed MAIA to determine follicle stimulating hormone (FSH), luteinzing hormone (LH), testosterone (T) and prolactin (PRL). The linear ranges were 0～150 IU/L (FSH), 0～200 IU/L (LH), 0.5～55 ng/L (T) and 0～250 ng/L (PRL). The detectable limits were 0.3 mIU/ml、0.25 mIU/ml、4 μIU/ml and 4 μIU/ml respectively. The CV s of within ran and day to day precision were <4% and <8%. The bias of average recovery was <5%. The estimates of interference were <3%. Compared MAIA with RIA, the correlation coefficients were 0.9826 (FSH), 0.8550 (LH), 0.8512 (T) and 0.9831 (PRL). The results of quality control samples were stable within 2 months. The reference ranges of FSH, LH, T and PRL were 0.25～10.18 IU/L, 0.33 ～8.95 IU/L, 0.54～11.11 ng/L and 8.77～33.43 ng/L respectively in adult serum ( n =95). Conclusion:MAIA is a reliable and accurate method for determining man hormones and can meet the clinical demands.