Analytical Evaluation of Lumipulse Anti-Mullerian Hormone Assay.

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.