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Abstract Background Anti-Müllerian hormone (AMH), a glycoprotein dimer, is produced by ovarian granulosa cells and its levels have been shown to directly correlate to the number of eggs remaining in the ovaries (ovarian reserve). Thus, measurements of AMH are widely used as an aid in the assessment of the ovarian reserve in women presenting to fertility clinics. This study aimed to evaluate the performance of the Siemens Atellica® IM AMH assay and compare it to the Beckman Access AMH assay. Methods The Atellica AMH assay is a fully automated chemiluminescent monoclonal sandwich immunoassay, while the Beckman Access AMH assay is also an automated chemiluminescent monoclonal sandwich immunoassay. Precision and linearity were assessed for the Atellica AMH assay using manufacturer-provided standards. Inter-laboratory correlation studies were completed using deidentified patient samples collected from 120 reproductive-age women undergoing fertility outpatient evaluation at Yale New Haven Health. Blood was drawn on the first office visit for fertility workup. AMH values were initially performed at Yale University using the Beckman Access AMH assay. Serum samples were then frozen (-20°C) and shipped on dry ice to the laboratory at the Ohio State University where they were thawed and analyzed using the Siemens Atellica AMH assay. Linear regression was employed for data analysis. Overall percent agreement using an AMH cut-off value of 1.77 ng/mL was calculated. AMH values 1.77 ng/mL were classified as positive and values ≤1.77 were classified as negative. Results The Siemens Atellica AMH assay exhibited good performance across the measuring range, with intra-assay and inter-assay coefficients of variation (CVs) ranging from 1.4% to 3.2% and 2.5% to 6.0%, respectively. The assay demonstrated linearity over the four recommended ranges (0.043-24.0 ng/mL) without significant bias observed. The Access and Atellica AMH assays demonstrated good overall agreement of 97% and were well-correlated with a R2 value of 0.9721. Conclusions The AMH assay was validated and routinely measured in-house using the Atellica automated assay. The Siemens Atellica AMH assay performs well across its measuring range and shows good agreement with Beckman Access AMH at the AMH cut-off of 1.77 ng/mL.
Shang et al. (Tue,) studied this question.