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

Abstract

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Generation II (Gen II) ELISA method used to measure Anti-Müllerian Hormone (AMH) from Beckman Coulter has recently been superseded by a fully automated AMH immunoassay.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.

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

“…This has been shown to have very good correlation with AMH measured using the modified Gen II ELISA. 30 Indeed, it has been proposed that correlation is good enough for adult reference intervals to be interchangeable between assays, 30 although not all authors have reported a direct equivalence in values. 31 Anti-Müllerian Hormone reference interval studies have been previously described for the male and females covering the paediatric age range; 7,23,24 however, these have been based upon AMH assays which are now redundant.…”

Biochemistry of the menopause

“…There are issues with standardization and harmonization of assays in use. [96][97][98][99][100][101][102] AMH is secreted into blood by small antral follicles. During the menstrual cycle, AMH concentrations are stable.…”

The effect of laparoscopic salpingectomy for ectopic pregnancy on ovarian reserve

“…All blood samples were processed using the Beckman Coulter manual Generation II ELISA (enzyme‐linked immunosorbent assay) method or the superseding automated Access AMH immunoassay. These assays have been demonstrated to have highly correlated results ( R 2 = 0.9822) making this data interchangeable without conversion …”