化学发光法与液相色谱串联质谱法测定多囊卵巢综合征女性体内性激素的比较分析  

Chemiluminescence immunoassay method and liquid chromatography tandem-mass spectrometry method for the determination of sex hormones in women with polycystic ovary syndrome

作　　者：葛佳佳 杨娜[2] 张潇莉 沈山梅[2] 葛卫红[2] GE Jia-jia;YANG Na;ZHANG Xiao-li;SHEN Shan-mei;GE Wei-hong(Nanjing Drum Tower Hospital of China Pharmaceutical University,Nanjing 210008;Drum Tower Hospital Affiliated to Medical School of Nanjing University,Nanjing 210008;Nanjing University of Chinese Medicine,Nanjing 210023)

机构地区：[1]中国药科大学南京鼓楼医院,南京210008 [2]南京大学医学院附属鼓楼医院,南京210008 [3]南京中医药大学,南京210023

出　　处：《中南药学》2022年第3期561-564,共4页Central South Pharmacy

摘　　要：目的比较化学发光免疫(CLIA)法和液相色谱串联质谱(LC-MS/MS)法测定血清中睾酮(T)和雌二醇(E2)浓度的一致性。方法纳入多囊卵巢综合征(PCOS)女性100例,分别使用CLIA法和LC-MS/MS法测定血清中的T和E2浓度。结果CLIA法测定E2均值水平高于LC-MS/MS法(P<0.001),T水平差异没有统计学意义(P=0.54)。在相关性分析中,T、E2的相关系数分别为0.774和0.883。在Bland-Altman分析中,T测定结果比值的均值为104.95%(95%CI:98.97%~111.28%),一致性限的95%置信区间为53.19%~207.0%;E2测定结果差值的均值为0.065(95%CI:0.057~0.072),一致性限的95%置信区间为-0.022~0.152。结论两种检测方法一致性不佳,CLIA法测定的性激素水平容易被高估,在PCOS诊断率中也存在一定误差;在条件允许的情况下,临床应开展LC-MS/MS法测定性激素含量。Objective To compare the chemiluminescence immunoassay(CLIA)method and liquid chromatography tandem-mass spectrometry(LC-MS/MS)method in the determination of serum testosterone(T)and estradiol(E2)concentration.Methods Totally 100 women with polycystic ovary syndrome were enrolled.The concentrations of T and E2 in the serum were measured by CLIA method and LC-MS/MS method,respectively.Results The mean level of E2 determined by CLIA method was higher than that of LC-MS/MS method(P<0.001),and there was no significant difference in T level(P=0.54).The correlation coefficients of T and E2 were 0.774 and 0.883,respectively.In the Bland-Altman analysis,the mean value of the ratio of T determination was 104.95%(95%CI:98.97%-111.28%),and the confidence interval of the 95%agreement limit was 53.19%-207.0%.The mean value of the difference of E2 determination results was 0.065(95%CI:0.057-0.072),and the confidence interval of the 95%agreement limit was-0.022~0.152.Conclusion The two detection methods are not consistent.The level of sex hormones measured by CLIA tends to be overestimated,with a certain error in the diagnosis rate of polycystic ovary syndrome.We should apply it accurately for the sex hormone determination under the conditions of LC-MS/MS.

关 键 词：多囊卵巢综合征 液相色谱串联质谱法 化学发光免疫法 睾酮 雌二醇 

分 类 号：R96[医药卫生—药理学]