Alternative automated AMH assays including the Beckman Coulter Access immunoassay are considered to provide similar results, but clarification of their suitability as an off-licence companion diagnostic for follitropin delta is required. Study design, size, duration: We systematically searched the existing literature for studies that had measured AMH using both automated assays in the same cohort of women. Individual paired patient data were acquired from each author and combined with unpublished data.
We collected paired AMH data on samples from women. Passing-Bablok regression and Bland-Altman plots were used to compare the analytical performance of the two assays. The degree of misclassification to different treatment categories was estimated should the Access AMH be used as a companion diagnostic instead of the Elecsys AMH in determining the dosing of follitropin delta. The average of the difference between the two assays was 2.
Overall Limitations reasons for caution: We compared the values of the two principal automated assays, extrapolation of our findings to other automated AMH assays would require similar comprehensive examination. Wider implications of the findings: An international standard for the calibration of the automated AMH assays is warranted to facilitate efficient use of AMH as a companion diagnostic.
The variable calibration of alternative automated AMH assays may adversely impact on the performance of the follitropin delta dosing algorithm. Keywords: AMH; IPD meta-analysis; automated assays; companion diagnostic; controlled ovarian hyperstimulation; follitropin delta; immunoassays; personalised medicine.
