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Lotierzo M, Urbain V, Dupuy AM, et al. Evaluation of a new automated immunoassay for the quantification of anti-Müllerian hormone. Pract Lab Med. 2021;25:e00220doi: 10.1016/j.plabm.2021.e00220.
Lotierzo, M., Urbain, V., Dupuy, A. M., & Cristol, J. P. (2021). Evaluation of a new automated immunoassay for the quantification of anti-Müllerian hormone. Practical laboratory medicine, 25e00220. https://doi.org/10.1016/j.plabm.2021.e00220
Lotierzo, Manuela, et al. "Evaluation of a new automated immunoassay for the quantification of anti-Müllerian hormone." Practical laboratory medicine vol. 25 (2021): e00220. doi: https://doi.org/10.1016/j.plabm.2021.e00220
Lotierzo M, Urbain V, Dupuy AM, Cristol JP. Evaluation of a new automated immunoassay for the quantification of anti-Müllerian hormone. Pract Lab Med. 2021 Apr 14;25:e00220. doi: 10.1016/j.plabm.2021.e00220. eCollection 2021 May. PMID: 34095410; PMCID: PMC8145750.
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Pract Lab Med. 2021 Apr 14;25:e00220. doi: 10.1016/j.plabm.2021.e00220. eCollection 2021 May.

Evaluation of a new automated immunoassay for the quantification of anti-Müllerian hormone.

Practical laboratory medicine

Manuela Lotierzo, Victor Urbain, Anne-Marie Dupuy, Jean-Paul Cristol

Affiliations

  1. Département de Biochimie et Hormonologie, Centre de Ressources Biologiques, CHU de Montpellier, Montpellier, France.
  2. PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, Centre de Ressources Biologiques, CHU de Montpellier, Montpellier, France.

PMID: 34095410 PMCID: PMC8145750 DOI: 10.1016/j.plabm.2021.e00220

Abstract

OBJECTIVES: A newly developed fully automated Lumipulse G AMH method (Fujirebio Diagnostics) was recently introduced in clinical laboratories for quantitative determination of anti-Müllerian hormone (AMH) level in human serum or plasma. AMH has emerged as value-added biomarker in the assessment of ovarian reserve, in diagnosis of granulosa cells cancer and in the investigation of gonadal disorders. We compared Lumipulse G AMH assay performances with other methods largely applied for AMH measurements.

DESIGN AND METHODS: The Lumipulse G AMH method based on two-step sandwich chemiluminescence enzyme immunoassay was assessed on Lumipulse G600II analyzer. The evaluation study included imprecisions, sensitivity and linearity whereas a comparison study was performed on a heterogeneous population of 114 patients by using the Elecsys AMH Plus assay on COBAS 8000 e602 module (Roche Diagnostics).

RESULTS: Lumipulse G AMH system showed good repeatability (within-run imprecision) with CV values below 1% (0.5% and 0.9% for high and low serum pools). Similarly within-laboratory imprecision was assessed with CV values of 2.5% and 1.6% for high and low level controls respectively. A linearity regression formula of 1.0119x-0.067 with a coefficient of determination (r

CONCLUSIONS: The performance of Lumipulse G AMH system was highly comparable with that of Roche Elecsys AMH Plus assay although approximately 10% higher values of AMH levels were observed for Lumipulse AMH system at all range of concentrations. Nevertheless the Lumipulse G system seems to be largely suitable for quantitative determination of AMH level in small-scale laboratory because of the reduced size and the use of single cartridge per test assuring flexibility and easy handling.

© 2021 The Authors.

Keywords: Anti-Müllerian hormone; Assessment of ovarian reserve; Automated immunoassay; Emerging biomarker; Method comparison

Conflict of interest statement

None.

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