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Abstract
We are grateful for the interest shown by Łukaszuk and colleagues in our article examining the discordance in values reported by the Generation II antimüllerian (AMH) assay compared with the anticipated performance (1). As they highlight, the values obtained were substantially lower than expected, in keeping with previous reports and may have placed patients at risk of iatrogenic ovarian hyperstimulation syndrome (OHSS). Concerns regarding the robustness of the AMH Gen II ELISA assay have been further fuelled by recent safety notices and technical bulletins from Beckman Coulter indicating that undiluted samples may give falsely low values due to interference from complement, but also that some samples diluted before addition to the plate may give falsely elevated values (2). At present, results published with the Gen II ELISA modified version have been variable (3), indicating that some technical issues have yet to be resolved for the manual ELISA assay.
We anticipate that the future for these manual assays is limited. Roche Diagnostics have recently published the performance characteristics of their automated immunoassay for AMH (4). Studies are underway to validate values obtained with this new assay before clinical application. We have previously highlighted the need for an international standard for AMH under the regulation of the National Institute of Biological Standards and Control 2 and 3, and this is reinforced by the data presented by Łukaszuk and colleagues. This would allow harmonization of current and future AMH assays, thereby eliminating the need to constantly revisit and establish assay-specific reference ranges and allow robust analysis of the utility (and limitations) of the measurement of AMH in a range of settings 2 and 5.
We anticipate that the future for these manual assays is limited. Roche Diagnostics have recently published the performance characteristics of their automated immunoassay for AMH (4). Studies are underway to validate values obtained with this new assay before clinical application. We have previously highlighted the need for an international standard for AMH under the regulation of the National Institute of Biological Standards and Control 2 and 3, and this is reinforced by the data presented by Łukaszuk and colleagues. This would allow harmonization of current and future AMH assays, thereby eliminating the need to constantly revisit and establish assay-specific reference ranges and allow robust analysis of the utility (and limitations) of the measurement of AMH in a range of settings 2 and 5.
Original language | English |
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Pages (from-to) | E2 |
Number of pages | 1 |
Journal | Fertility and Sterility |
Volume | 102 |
Issue number | 1 |
DOIs | |
Publication status | Published - Jul 2014 |
Keywords / Materials (for Non-textual outputs)
- ANTI-MLLERIAN HORMONE
- WOMEN
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