磁微粒吖啶酯化学发光法检测AMH的性能评估及成年女性AMH参考区间的建立

doi:10.3969/j.issn.1673-8640.2021.01.020

摘要/Abstract

摘要：

目的评价磁微粒吖啶酯化学发光法检测抗苗勒管激素（AMH）的性能,建立成年女性AMH的参考区间。方法依据美国临床试验室标准化协会（CLSI）相关文件对磁微粒吖啶酯化学发光法检测AMH的性能（空白限、检测限、定量限、精密度,线性范围）进行评价。采用线性回归分析和相对偏移评估电化学发光法与磁微粒吖啶酯化学发光法检测AMH的一致性。评估血清样本在不同保存条件下的稳定性及不同样本类型之间的差异。采用百分位数法建立成年女性AMH的参考区间。结果磁微粒吖啶酯化学发光法检测AMH的空白限为0.001 ng/mL、检出限为0.02 ng/mL、定量限为0.08 ng/mL,高、低值样本的重复性分别为1.6%、1.3%,批间精密度分别为2.1%、2.2%,总不精密度分别为3.1%、3.2%,线性范围为0.02~27.22 ng/mL。电化学发光法与磁微粒吖啶酯化学发光法检测AMH的相关性良好（r=0.975 3）。血清和血浆的检测结果呈线性关系。血清样本在室温（20~25 ℃）条件下可稳定3 d,在4、-20、-80 ℃条件下可稳定7 d。20~24、25~29、30~34、35~39、40~44、45~49和≥50岁女性的AMH参考区间分别为1.20~10.21、1.14~9.17、0.55~8.18、0.25~7.02、0.07~4.59、0.01~2.11、<0.39 ng/mL。结论磁微粒吖啶酯化学发光法检测AMH具有良好的分析性能,建立的AMH参考区间可为临床诊治相关疾病提供依据。

关键词: 抗苗勒管激素, 磁微粒吖啶酯化学发光法, 参考区间, 检测性能评价

Abstract:

Objective To evaluate the performance of acridinium ester labeled direct chemiluminescence method for the detection of anti-mullerian hormone（AMH）,and to establish adult female AMH reference interval. Methods The blank limit,detection limit,quantitative limit,precision and linear range of acridinium ester labeled direct chemiluminescence method were evaluated according to the clinical and Laboratory Stabdards Institute（CLSI）documents. The consistency of electrochemiluminescence and acridinium ester labeled direct chemiluminescence method was analyzed by regression analysis and bias evaluation. The stability under different storage conditions and the difference of different specimen types were evaluated. Percentile method was used to establish a reference interval for adult female AMH. Results The blank limit was 0.001 ng/mL,the detection limit was 0.02 ng/mL,and the quantitative limit was 0.08 ng/mL. The repeatability at low concentration was 1.3%,the inter-assay precision was 2.2%,and the total imprecision was 3.2%. The repeatability at high concentration was 1.6%,the inter-assay precision was 2.1%,and the total imprecision was 3.1%. The linear interval was 0.02-27.22 ng/mL. Electrochemiluminescence and acridinium ester labeled direct chemiluminescence method had a good correlation（r=0.975 3）. There was a linear correlation between the results of serum and plasma. The serum samples were stable for 3 d at room temperature（20-25 ℃） and for 7 d at 4,-20 and -80 ℃. The reference intervals for AMH for adult females aged 20-24,25-29,30-34,35-39,40-44,45-49 and ≥50 years old were 1.20-10.21,1.14-9.17,0.55-8.18,0.25-7.02,0.07-4.59,0.01-2.11 and <0.39 ng/mL,respectively. Conclusions Acridinium ester labeled direct chemiluminescence method has good performance for detecting AMH,and the AMH reference interval of adult females can provide a reference for clinic.

Key words: Anti-mullerian hormone, Acridinium ester labeled direct chemiluminescence method, Reference interval, Performance evaluation

中图分类号:

R446.1

岳朝艳, 段朝晖, 章迪, 韦婕, 罗晓红, 张倩岚, 伍勇, 应春妹. 磁微粒吖啶酯化学发光法检测AMH的性能评估及成年女性AMH参考区间的建立[J]. 检验医学, 2021, 36(1): 95-100.

YUE Chaoyan, DUAN Chaohui, ZHANG Di, WEI Jie, LUO Xiaohong, ZHANG Qianlan, WU Yong, YING Chunmei. Performance evaluation of acridinium ester labeled direct chemiluminescence method for the detection of AMH and establishment of adult female AMH reference interval[J]. Laboratory Medicine, 2021, 36(1): 95-100.

图/表 7

参考文献 19

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项目	电化学发光法	磁微粒吖啶酯化学发光法
空白限/（ng/mL）	0.007	0.001
检测限/（ng/mL）	0.01	0.02
定量限/（ng/mL）	0.03	0.08
低值
重复性（CV）/%	1.5	1.3
批间精密度（CV）/%		2.2
总不精密度（CV）/%	2.3	3.2
高值
重复性（CV）/%	1.5	1.6
批间精密度（CV）/%		2.1
总不精密度（CV）/%	3.0	3.1
线性范围/（ng/mL）	0.01~23.00	0.02~27.22

项目	电化学发光法	磁微粒吖啶酯化学发光法
空白限/（ng/mL）	0.007	0.001
检测限/（ng/mL）	0.01	0.02
定量限/（ng/mL）	0.03	0.08
低值
重复性（CV）/%	1.5	1.3
批间精密度（CV）/%		2.2
总不精密度（CV）/%	2.3	3.2
高值
重复性（CV）/%	1.5	1.6
批间精密度（CV）/%		2.1
总不精密度（CV）/%	3.0	3.1
线性范围/（ng/mL）	0.01~23.00	0.02~27.22

AMH给定值/（ng/mL）	SE/ （ng/mL）	SE%/%	允许误差/%
1	0.178 3	17.8	25
5	0.173 5	3.5	25
10	0.167 5	1.7	25
15	0.161 5	1.1	25

AMH给定值/（ng/mL）	SE/ （ng/mL）	SE%/%	允许误差/%
1	0.178 3	17.8	25
5	0.173 5	3.5	25
10	0.167 5	1.7	25
15	0.161 5	1.1	25

抗凝管类型	Passing-Bablok回归方程	斜率（95%可信区间）	r值	平均偏移（95%可信区间）/%
分离胶促凝管	Y=-0.042 0+1.008X	1.008 4（0.961 9~1.085 4）	0.998 9	0.85（-1.60~3.30）
肝素锂抗凝管	Y=-0.041 8+1.003X	1.003 5（0.940 0~ 1.032 4）	0.999 5	0.58（-2.00~3.10）
柠檬酸钠抗凝管	Y=0.055 7+0.927 0X	0.927 0（0.886 0~ 1.015 3）	0.998 6	-4.50（-7.50~-1.50）
EDTA抗凝管	Y=0.046 0 +0.959 7X	0.959 7（0.930 6~1.000 0）	0.999 1	-1.70（-4.50~1.10）