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Analytical Evaluation of Lumipulse Anti-Mullerian Hormone Assay by Francois Fraissinet, Aurelie Gesland, Jennifer Guillerme, Frederic Ziegler, Valery Brunel

Background: The measurement of serum Anti-Mullerian hormone (AMH) is used in daily practice to estimate the ovarian reserve in women.
Methods: The aim of this study was to evaluate the new Lumipulse AMH® immunoassay (Fujirebio) with regard to the reliability with two preexisting assays: Elecsys AMH Plus® (cobas®, Roche) and Vidas AMH® (bioMérieux). Precision of Lumipulse AMH was evaluated on the Lumipulse G600 II using the manufacturer’s quality controls. Thirty-three samples were used for method comparison.
Results: Lumipulse AMH repeatability and intermediate precision did not exceed 4.1 %. There was a proportional bias between Lumipulse and Cobas method and between Lumipulse and Vidas whereas a good agreement was found between Cobas and Vidas.
Conclusions: Lumipulse AMH assay demonstrated good precision and good agreement with the two other methods up to 6 ng/mL. Nevertheless, this study shows the need to standardize AMH assays to improve the comparability of the methods.

DOI: 10.7754/Clin.Lab.2020.200737