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