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

Kylie Pearson, Matthew Long, Josephine Prasad, Ye Ying Wu, Michael Bonifacio, Kylie Pearson, Matthew Long, Josephine Prasad, Ye Ying Wu, Michael Bonifacio

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II (Gen II) ELISA method used to measure Anti-Müllerian Hormone (AMH) from Beckman Coulter has recently been superseded by a fully automated AMH immunoassay.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

Figures

Fig. 1
Fig. 1
Linearity of the Access AMH assay on the Access2 and DxI800 analysers using a. calibrator material or b. patient sera. c. Linearity at the low end of the concentration range using patient sera. Regression line (blue), 95 % confidence intervals (red). All results are shown in pmol/L
Fig. 2
Fig. 2
a. Correlation between Access AMH and Gen II ELISAs on the Access2 and DxI800 instruments (n = 142). b. Correlation between results from Access2 analysers in different locations (n = 46) and Access2 and DxI800 analysers (n = 142). Upper panels represent the Passing-Bablok diagram with the regression line (blue) and the 95 % confidence interval (red). Lower panels represent the Bland-Altman plots with mean (blue) and 95 % confidence intervals (red). All results are shown in pmol/L
Fig. 3
Fig. 3
Correlation between automated AMH and Gen II ELISA normal female reference ranges. Individual results (blue points) and 10th, 50th and 90th percentile median values for 5-year age groups for Access AMH and Gen II ELISA methods (n = 489)

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