Performance characteristics of the Access AMH assay for the quantitative determination of anti-Müllerian hormone (AMH) levels on the Access* family of automated immunoassay systems

Demirdjian, Gaiane; Bord, S.; Lejeune, C.; Masica, Ryan; Rivière, Dominique; Nicouleau, L.; Denizot, Philippe; Marquet, Pierre-Yves

doi:10.1016/j.clinbiochem.2016.08.005

Cited by 42 publications

(53 citation statements)

References 22 publications

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“…In contrast, follitropin delta dosing has been linked with the Roche Elecsys ® AMH immunoassay as the companion diagnostic that was validated in the phase 3 ESTHER‐1 registration study . In the current study, assay variability was 2.5%‐3.5%, which is comparable to published data for the same assay and the automated Beckman Coulter Access AMH assay . Biological variability is therefore likely to have been the main contributor to the total variability.…”

Section: Discussionsupporting

confidence: 70%

“…7 In the current study, assay variability was 2.5%-3.5%, which is comparable to published data for the same assay 32 and the automated Beckman Coulter Access AMH assay. 33 Biological variability is therefore likely to have been the main contributor to the total variability. Reassuringly, the results indicate that the observed variation in AMH has very little impact on the dose of follitropin delta; it is anticipated that the dose adjustment for other gonadotropins would also be minor using alternative AMH algorithms.…”

Section: Discussionmentioning

confidence: 99%

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Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Nelson

Mannaerts

Andersen

et al. 2019

Clinical Endocrinology

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Summary Objective The stability of anti‐Müllerian hormone (AMH) across and between menstrual cycles has been the subject of debate. The objective of this analysis was to study the inter‐ and intracycle variability in repeated measurements and assess the impact on an individualized gonadotropin dosing algorithm and predicted oocyte yield. Design Retrospective analysis of repeat AMH measures from a randomized controlled trial. Patients A total of 1326 women aged 18‐40 years. Measurements Serum AMH levels at screening and at cycle day 2‐3 in up to three ovarian stimulation cycles. AMH variability and its impact on gonadotropin dose and the predicted number of oocytes. Results Repeat serum AMH measurements were strongly correlated within individual women (correlation coefficient 0.92). AMH exhibited limited within‐subject variation (coefficient of variation 23%), a small time‐related decline (mean 6% decrease/y), but no systematic variation across the menstrual cycle. Irrespective of whether the AMH screening value or the AMH at the initiation of ovarian stimulation was used, for women with an AMH level <15 pmol/L, 93% would receive the same gonadotropin dose and attain an identical number of oocytes in 97% of cases. For women with an AMH level ≥15 pmol/L, 80% would receive an individualized dose within ±1.5 μg and 90% would attain ±1 oocyte. Conclusion AMH variability had limited impact on individualized gonadotropin dosing, with 95% of women predicted to obtain an oocyte yield that does not vary beyond 1 oocyte count, irrespective of whether a random or early follicular AMH measurement was used to determine the individualized gonadotropin dose.

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Section: Discussionsupporting

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Nelson

Mannaerts

Andersen

et al. 2019

Clinical Endocrinology

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“…After analysis, samples were stored at +4°C for no more than 12 hours before the plasma supernatant was removed from cells into a secondary container in order to maintain AMH stability 27 and stored frozen at −80°C until analysis. Surplus specimens of acellular plasma marked for disposal were used following completion of all diagnostic investigations.…”

Section: Sample Collection Storage and Analysismentioning

confidence: 99%

“…Specimens were collected in blood tubes preloaded with Lithium Heparin and centrifuged within 30 minutes of receipt in the laboratory to separate plasma from cellular components. After analysis, samples were stored at +4°C for no more than 12 hours before the plasma supernatant was removed from cells into a secondary container in order to maintain AMH stability 27 and stored frozen at −80°C until analysis. Samples were analysed for testosterone using a liquid chromatography high-resolution accurate mass-mass spectrometry (LC-HRAM/MS) assay.…”

Section: Sample Collection Storage and Analysismentioning

confidence: 99%

Paediatric Anti‐Müllerian Hormone measurement: Male and female reference intervals established using the automated Beckman Coulter Access AMH assay

Jopling

Yates

Burgoyne³

et al. 2018

Endocrino Diabet & Metabol

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Summary Objective Anti‐Müllerian Hormone (AMH) concentration is high at birth in males, demonstrating the presence of functional testicular tissue in the prepubertal period, and acting as a useful marker in the investigation of paediatric reproductive disorders. AMH also provides a tool in the investigation of female virilization, premature ovarian failure and polycystic ovarian syndrome in childhood. Robust, assay‐specific paediatric AMH reference intervals are therefore required for clinical interpretation of results. The aim of this study was to derive age‐specific AMH reference intervals for males and females aged 0‐18 years. Design and Patients Plasma samples were obtained from patients at Royal Manchester Children's Hospital and analysed for AMH using the automated Beckman Coulter Access AMH Assay. Patients under investigation for paediatric reproductive or endocrine disorders were excluded from the study. Measurements Seven hundred and 2 patient plasma samples (465 male, 237 female) were subject to AMH measurement, and results were analysed in order to derive continuous and discrete reference intervals for the paediatric age range. Results Clear discrimination between male and female AMH results was evident in the prepubertal age range, with some overlap between the genders following pubertal onset. Conclusions We have derived age‐related reference intervals for plasma AMH in the paediatric age range (0‐18 years) using the automated Beckman Coulter Access AMH assay which will aid in the investigation of paediatric endocrine disorders such as disorders of sexual development.

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“…During the course of our study, other sets of reference ranges were published for the Access AMH assay in white and Chinese populations. 30,31 However, their sample sizes were much smaller and, as with most other reported ones, the reference ranges were stratified by 5-yearly age groups. Our current set of reference ranges, on the other hand, was derived from a larger healthy cohort with more refined year-by-year age stratification.…”

Section: Interpretationsmentioning

confidence: 96%

Age‐specific reference ranges of serum anti‐müllerian hormone in healthy women and its application in diagnosis of polycystic ovary syndrome: a population study

et al. 2020

BJOG

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Objective To establish the age‐specific centiles of serum anti‐müllerian hormone (AMH) levels in Chinese women, and to explore the use of multiples of median (MoM) AMH levels for the diagnosis of polycystic ovary syndrome (PCOS). Design An observational study. Setting University‐affiliated hospitals and community clinics. Population We included 3137 healthy women aged 20–44 years recruited prospectively or who had archived serum samples from previous research projects. Another validation cohort of 751 women with PCOS as well as ovulatory controls, which was a convenient sample of women attending for infertility or menstrual disorders, was also studied. Methods The serum samples were assayed for AMH by the automated Access AMH assay. Main outcome measures Age‐specific reference ranges were constructed on the primary cohort with the Lambda‐Mu‐Sigma method. The MoM AMH of each subject in the validation cohort was calculated. Results Centile curves of serum AMH level against age were established. MoM AMH was significantly higher in women with PCOS than in controls (P < 0.05). The area under the ROC curve was 0.852 (95% confidence interval [CI] 0.825–0.877) (P < 0.0001) for discriminating women with PCOS from ovulatory controls by MoM AMH. Conclusions We established a set of year‐by‐year age‐specific reference ranges of serum AMH levels in Chinese women. The MoM AMH derived from this set of reference ranges is a promising tool to replace antral follicle count in the diagnosis of PCOS. Tweetable abstract A set of age‐specific reference ranges of AMH levels was established in Chinese women. Multiples of median AMH may be used to diagnose PCOS.

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Performance characteristics of the Access AMH assay for the quantitative determination of anti-Müllerian hormone (AMH) levels on the Access* family of automated immunoassay systems

Abstract: The fully automated Access AMH immunoassay demonstrates excellent analytical performance. As a consequence, the availability of this assay will represent a robust, fast and precise alternative to manual AMH assay testing.

Cited by 42 publications

References 22 publications

Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Anti‐Müllerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta

Paediatric Anti‐Müllerian Hormone measurement: Male and female reference intervals established using the automated Beckman Coulter Access AMH assay

Age‐specific reference ranges of serum anti‐müllerian hormone in healthy women and its application in diagnosis of polycystic ovary syndrome: a population study

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