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Evaluation of a fluorescent-based point-of-care AMH assay: A bicentric assessment of analytical performance, method agreement, and usability.
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DOI：10.1016/j.cca.2026.120998.png)
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Abstract
En 中文
Background: Anti-M & uuml;llerian hormone (AMH) measurement is central to ovarian reserve assessment but remains affected by inter-method variability among immunoassays. Point-of-care testing (POCT) enables rapid and decentralized AMH testing; however, independent evaluation of analytical performance and agreement with routine laboratory methods is required prior to clinical implementation. Objective: To evaluate the analytical performance, method agreement, and usability of a fluorescent-based point-of-care AMH assay using a bicentric study design. Methods: Analytical precision and trueness were assessed at two independent sites using three levels of quality control material. Method comparison was performed on 304 anonymized residual serum samples from routine laboratory requests, including infertility assessment, polycystic ovary syndrome (PCOS) investigation, in vitro fertilization (IVF) monitoring, and cancer surveillance, covering a clinically relevant AMH range (0.1-13 ng/mL). Statistical analyses included Passing-Bablok regression, Spearman correlation, and Bland-Altman analysis. System usability was assessed using a structured questionnaire. Results: A strong correlation was observed between the POCT AMH assay and the routine laboratory method (Spearman r = 0.967, p < 0.0001). Passing-Bablok regression showed a slope of 0.925 and an intercept of 0.213, indicating a proportional bias. Quality control imprecision ranged from 4.1% to 13.6% (CV), with positive biases between 2.9% and 17.8%. A concentration-dependent pattern was observed, with overestimation at low concentrations, increased deviation in the mid-range, and near-equivalence at higher values. Bland-Altman analysis confirmed greater dispersion at low-to-mid AMH levels. Usability evaluation indicated high ease of use and limited training requirements. Conclusions: The fluorescent-based AMH POCT assay demonstrated acceptable analytical performance, strong correlation with a routine laboratory method, and favourable usability. However, until harmonisation across methods is achieved, cautious interpretation and confirmatory laboratory testing remain essential when results are close to clinical decision thresholds.
Keywords:
AMH assay
point-of-care testing
analytical performance
method agreement
usability
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