不同标本类型和检测方法对抗缪勒管激素结果影响的比对研究

目的以罗氏诊断电化学发光法(ECLIA)检测抗缪勒管激素(AMH)作为参照,对珠海丽珠化学发光法(CLIA)测定AMH结果进行评估。方法选取120例卵巢功能异常的女性血清样本,分别用罗氏Cobas 6000 e601全自动电化学发光免疫分析仪与珠海丽珠LEACL-600全自动化学发光免疫分析仪以双盲方式进行定量检测,通过统计学分析评估两者方法测定AMH的一致性。另外随机收集55例受试者同源血清、血浆,比较2种类型样本结果的一致性情况,评估其临床可接受度。结果120例血清样本共有效入组117例,罗氏诊断AMH结果均值6.06 ng/mL,结果中最高值为:15.11 ng/mL,最低值为0.248 ng/mL。2种方法检测的AMH结果高度相关(r=0.994,P<0.01);线性回归方程:y=0.9912x+0.0418,拟合度系数R²=0.9896>0.975。55例同源血清与血浆样本结果同样高度相关(r=0.997,P<0.01);线性回归方程:y=0.9963x+0.0627拟合度系数R²=0.9944>0.975。对方法学比对与同源标本比对的回归方程的系数进行t检验显示,截距(a)之差异均无统计学意义(P>0.05),而斜率(b)比较差异均有统计学意义(P<0.05)。Bland-Altman一致性分析结果均在临床可接受范围内。结论2种方法检测AMH结果具有高度的相关性,珠海丽珠全自动化学发光免疫分析仪检测抗缪勒氏管激素可用于临床病情与疗效的监控,且同源血浆、血清样本对比试验结果一致性较好,临床接受度高。

Comparative study of the influence of different specimen types and detection methods on antimullerian hormone

Objective To evaluate the results of determination of antimullerian hormone(AMH)with chemilum-inescence analysis(CLIA)according to electrochemiluminescence immunoassay(ECLIA)as a reference.Methods The serum samples of 120 women with abnormal ovarian function were detected by Roche Cobas6000 E601 automatic electro-chemiluminescence immunoassay analyzer and Zhuhai Lizhu leacl-600 automatic chemiluminescence immunoassay an-alyzer respectively in a double-blind way.The consistency of AMH was evaluated by statistical analysis.In addition,55 patients with homologous serum and plasma were randomly collected to compare the consistency of the results of the two types samples to evaluate their clinical acceptability.Results A total of 117 cases of 120 serum samples were effectively enrolled.The mean value of Roche diagnosis of AMH was 6.06 ng/mL,the highest value was 15.11 ng/mL,and the lowest value was 0.248 ng/mL.AMH detected by two methods were highly correlated(r=0.994,P<0.01);linear regression equa-tion:y=0.9912x+0.0418,fitting coefficient R²=0.9896>0.975.55 cases homologous serum were highly correlated with plasma samples(r=0.997,P<0.01);linear regression equation:y=0.9963x+0.0627,fitting coefficient R²=0.9944>0.975.T-test showed that there was no significant difference in intercept(a)but significant difference in slope(b)(P<0.05).The Bland Altman consistency analysis results were within the clinical acceptable range.Conclusion There is a high correlation between the results of AMH detected by the two methods.Zhuhai Lizhu automatic chemiluminescence immunoassay analyzer can be used to monitor the clinical condition and curative effect,and the results of homologous plasma and serum samples have good consistency and high clinical acceptance.