B-093 Analytical performances of a novel fluorescent immunoassay of anti-Müllerian hormone and establishment of the reference intervals in Chinese children

Abstract Background Anti-Müllerian Hormone (AMH) plays a important role in children growth and the concentrations change with age as well as gender. This study aimed to evaluate the analytical performances of a novel AMH assay based on the cycle enhanced fluorescence immunoassay (CEFIA) and establish the pediatric reference intervals of AMH Methods The experiments on imprecision, sensitivity, linearity, linear range and comparison were carried out to evaluate the analytical performances. Furthermore, the concentrations of serum AMH in 238 females and 346 males aged 0-18 years were measured by the Pylon AMH assays and the reference ranges for ages group were calculated using robust methods. Results The repeatability and the within-laboratory imprecision CVs of the assay were 3.7% and 6.4% at at 2.25 ng/mL, and 4.6% and 6.4% at 15.49 ng/mL, respectively. The sensitivity of the assay (LoB =0.05 ng/mL, LoD= 0.1 ng/mL and LoQ= 0.3 ng/mL) was verified. The AMH Pylon assays showed good linearity within the detection range (between 0.1 and 24 ng/ml) and can report up to 480 ng/mL with 20x pre-dilution of samples. The AMH concentrations of serum samples measured by the Pylon assays correlated to those measured by the Elecsys assays. In the males under 18 years old, the AMH levels were high at birth (0-1 month: median 95.10 ng/mL) and continued to increase to a peak between 7 months to one year old (median 158.80 ng/mL) before they started to decrease with age to the lowest level between 15 and 18 years old (median 6.31 ng/mL). On the other side, the serum AMH concentrations in females were low at birth (0-1 month: median 0.20 ng/mL) and increased with age (15-18 years old: median 3.03 ng/mL). The reference intervals were provided for each gender and age groups,respectively. Conclusions The Pylon AMH assays showed good analytical performances, and the AMH reference intervals in chinese children determined may provide a basis for the use in clinical diagnosis and treatment of related diseases.