biochimica clinica

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CONTRIBUTI SCIENTIFICI – Scientific Papers

Volume:

Biochimica Clinica, vol.47, n.4, pag 360-4

Pubblicato on-line:

Settembre 25, 2023

DOI:

10.19186/BC_2023.071

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Evaluation of a new anti-müllerian hormone (amh) assay: a comparison between atellica amh (Siemens Healthineers) and access amh (Beckman Coulter) assays

AUTORI

Antonino Sammartano1, Giulia Testa1, Lorenzo Barusi2, Luigi Ippolito1
1U.O. Clinical Pathology, Medical and Diagnostics Department P.O. Fidenza, AUSL Parma, Italy 2U.O. Obstetrics and Gynecology, Surgery Department P.O. Fidenza, AUSL Parma, Italy

ABSTRACT

Introduction: anti-müllerian Hormone (AMH) is a key marker of ovarian reserve; its serum levels are strongly correlated with the antral follicle count. Aim of this study is a comparison between two automated AMH assays: the new generation Atellica Solution® AMH sandwich immunoassay (AMH-AS) and the more widely used Access AMH immunochemiluminescence assay performed on Beckman-Coulter DxI analyzer (AMH-DxI) currently used in our laboratory. This evaluation has been performed according to the CLSI EP09-A3 guideline.
Methods: 120 consecutive serum samples with a AMH test request from the Medically Assisted Procreation center (PMA), have been used for the study. All samples were handled and processed in parallel. Statistical data analysis was performed using Stata program.
Results: passing-Bablok regression of AMH assays showed a good agreement between AMH-AS and AMH-DxI. The regression equation was AMH- AS = -0.0070+AMH-DxI x 0.994. In addition, method comparison did not show a large variance around the regression line. No significant differences neither in percentage or absolute values were identified through the Bland Altman test, thus showing a good concordance between the two methods.
Conclusions: method comparison is an important step in the validation process of assays and instruments. This comparison showed a good agreement between AMH-AS and AMH-DxI assays. Our results demonstrated an excellent analytical performance of fully automated AMH-AS immunoassay; therefore the use of this method will provide a better option in evaluating different clinical conditions including infertility treatment.

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