Performance of the two new fully automated anti-Müllerian hormone immunoassays compared with the clinical standard assay

Helden, Josef van; Weiskirchen, Ralf

doi:10.1093/humrep/dev127

Cited by 79 publications

(55 citation statements)

References 26 publications

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“…These findings indicate that the past issues have been overcome when comparing the new and previous Beckman Coulter methods. In support of our results, van Helden and Weiskirchen [22] demonstrated good correlations between the Gen II ELISA and both the Access AMH assay and the new automated Elecsys system from Roche, both of which utilise the same monoclonal antibodies. The authors also demonstrated an extremely tight correlation between the Access and Elecsys assays, and these results were further [28] demonstrated a similar pattern of bias between the Gen II and Elecsys methods and proposed that this may be in part due to inter-laboratory bias with the Gen II method.…”

Section: Discussionsupporting

confidence: 86%

Assessment of the Access AMH assay as an automated, high-performance replacement for the AMH Generation II manual ELISA

Pearson¹

2016

Preprint

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Background: The manual Generation II (Gen II) ELISA method used to measure Anti-Müllerian Hormone (AMH) from Beckman Coulter has recently been superseded by a fully automated AMH immunoassay. The aim of this study was to evaluate the performance of the Access AMH assay and directly compare it to the modified Gen II ELISA method. A secondary aim was to verify that the fertile age-related AMH range previously established using the Gen II ELISA could be used to interpret results from the new automated Access assay. Methods: The precision, stability, linearity, measurement range and detection limits were determined using recombinant AMH and patient serum samples. Different diluents and their effects on AMH concentration were compared. A correlation study was performed on patient samples to compare the Access AMH assay to the ELISA method on the Access2 and DxI800 analysers. The fertile AMH range was verified by comparing the 10th, 50th and 90th percentile values from both methods obtained from 489 natural conception pregnant women. Results: The Access AMH assay showed good performance across the measuring range for both intra-assay (CV 1.41-3.30 %) and inter-assay (CV 3.04-5.76 %) precision and acceptable sample stability. Dilution of the high concentration samples with the recommended diluent resulted in a small but significant downward shift in values. The assay was linear over the range of values recommended by the manufacturer, allowing for accurate reporting within the reported range. The two assay types were highly correlated (R 2 = 0.9822 and 0.9832 for Access2 and DxI800, respectively), and the differences observed between the Access2 and DxI800 analysers were within clinically acceptable ranges, indicating that the methods are interchangeable. Furthermore, we demonstrated that results from the published reference range for the Gen II ELISA correlate with those from the automated Access AMH assay. Conclusion: Here, we verified the published performance of the Access AMH assay and showed excellent correlation with the Gen II ELISA method. Moreover, we validated this correlation by confirming that the results from a fertile AMH reference range established using the preceding Gen II ELISA are interchangeable with the new automated Access AMH assay.

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Section: Discussionsupporting

confidence: 86%

Assessment of the Access AMH assay as an automated, high-performance replacement for the AMH Generation II manual ELISA

Pearson¹

2016

Preprint

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“…The advent of newer, more sensitive and precise assaysautomated electrochemiluminescence immunoassays (1,14,15) and a pico-AMH enzyme-linked immunosorbent assay (16)-may allow further refinement of prognostic characteristics for women with ultralow AMH who undergo ART. Until such studies are completed, it seems advisable not to refuse treatment solely on the basis of ultralow AMH and to counsel patients appropriately regarding the prognostic factors for cancellation and outcomes as described in this study.…”

Section: Discussionmentioning

confidence: 99%

“…The expected clinical response when the AMH value is ultralow has not been well described. Ultralow AMH level is defined here as %0.16 ng/mL, the lowest level detectable by a standard clinical AMH assay (Gen II enzyme-linked immunosorbent assay Beckman-Coulter) (1).…”

mentioning

confidence: 99%

Prognostic indicators of assisted reproduction technology outcomes of cycles with ultralow serum antimüllerian hormone: a multivariate analysis of over 5,000 autologous cycles from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System database for 2012–2013

Seifer

Tal

Wantman³

et al. 2016

Fertility and Sterility

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“…Since 2013, a pre‐mixing step is introduced for the AMH Gen II assay, increasing reproducibility of measurements (Han, Mcshane, Sahertian, White, & Ledger, ). Recently, the same antibodies as used in the AMH Gen II assay have been used in two fully automated immunoassays, with higher analytical sensitivity (Van Helden & Weiskirchen, ). Studies on dogs or cats have not been published using the automated methods.…”

Section: Interpretation Of Amh Test Results With Different Immunoassaysmentioning

confidence: 99%

Diagnostic possibilities from a serum sample—Clinical value of new methods within small animal reproduction, with focus on anti‐Müllerian hormone

Holst

2016

Reprod Domestic Animals

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ContentsDuring the last decade, analysis of anti-Müllerian hormone (AMH), highly conserved between mammalian species, has contributed to new information in reproductive endocrinology, due to clinically available diagnostic assays. AMH is produced solely in the gonads, in the Sertoli cells of testes and granulosa cells of the ovary, and thus offers possibilities to diagnose physiologic and pathologic conditions involving these organs. This article reviews indications for AMH analysis in cats and dogs, including diagnosing the presence of gonads, and granulosa or Sertoli cell tumours. Diagnostic challenges are addressed. One specific organ, the prostate, is commonly affected by pathologic changes in older dogs. A commercial assay for analysing canine prostatic specific esterase (CPSE) enables analysis of CPSE in clinical practice, of potential value in the workup of benign prostatic hyperplasia in male dogs. This is described in this review, as is a new method for analysis of steroids: liquid chromatography-tandem mass spectrometry LC-MS/MS. Steroids have since long been analysed in studies on reproduction, and LC-MS/MS has the advantage of allowing analysis of panels of multiple steroids from small sample volumes. Altogether, these available methods may give new insights into small animal reproduction and are valuable tools for the practicing veterinarian.

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Performance of the two new fully automated anti-Müllerian hormone immunoassays compared with the clinical standard assay

Abstract: We declare no financial relationships or competing interests.

Cited by 79 publications

References 26 publications

Assessment of the Access AMH assay as an automated, high-performance replacement for the AMH Generation II manual ELISA

Assessment of the Access AMH assay as an automated, high-performance replacement for the AMH Generation II manual ELISA

Prognostic indicators of assisted reproduction technology outcomes of cycles with ultralow serum antimüllerian hormone: a multivariate analysis of over 5,000 autologous cycles from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System database for 2012–2013

Diagnostic possibilities from a serum sample—Clinical value of new methods within small animal reproduction, with focus on anti‐Müllerian hormone

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