Clinica Chimica Acta Study Validates Finecare™ Rapid AMH Test

A peer-reviewed study published in Clinica Chimica Acta (Volume 588, 2026, Article 120998) has independently evaluated the analytical performance, method agreement, and usability of the Wondfo Finecare™ FIA Meter II Plus SE for anti-Müllerian hormone (AMH) measurement. 
 

Figure: Finecare™ FIA Meter II Plus SE

 
Conducted at Cliniques universitaires Saint-Luc (UCLouvain, Brussels, Belgium) and SmartLab Clinical Laboratory (Amman, Jordan), this bicentric study compared the fluorescent immunoassay AMH assay with the Roche cobas 8000 e602 automated electrochemiluminescence immunoassay (ECLIA) platform. The findings provide independent clinical evidence supporting the application of rapid, decentralized AMH measurement while outlining analytical considerations for results near clinical decision thresholds.
 

A Bicentric Evaluation Reflecting Routine Reproductive Endocrinology Practice

To assess method agreement under routine clinical laboratory conditions, investigators analyzed 304 anonymized serum samples spanning an AMH concentration range of 0.1–13 ng/mL. The cohort represented a broad spectrum of reproductive endocrinology diagnostics, including infertility assessment, polycystic ovary syndrome (PCOS) investigation, in vitro fertilization (IVF) monitoring, and cancer surveillance.
 

Key Analytical & Performance Highlights:

· Strong Method Correlation: Across the overall study population, the Finecare™ AMH POCT assay demonstrated outstanding correlation with the routine ECLIA method (Spearman r = 0.967, p < 0.0001).
· Regression Analysis: Passing–Bablok regression yielded a slope of 0.925 and an intercept of 0.213.
· Precision & Trueness: Quality-control evaluations across both study sites showed coefficients of variation (CV) ranging from 4.1% to 13.6%, with positive biases between 2.9% and 17.8%, confirming acceptable analytical performance in real-world settings.
 

 
Figure: Passing–Bablok regression analysis showing strong analytical agreement between the Wondfo Finecare™ AMH POCT assay and the reference automated ECLIA platform (Roche cobas 8000 e602) across 304 clinical serum samples (Spearman r = 0.967, p < 0.0001).

Understanding Method Agreement Across Concentration Ranges

Beyond overall correlation, the investigators examined agreement across low-, mid-, and high-concentration ranges:
· Concentration-Dependent Pattern: Measurements showed slight overestimation at lower concentrations, greater dispersion in the mid-range, and near-equivalent agreement at higher AMH concentrations.
· Bland–Altman Analysis: Confirmed narrower limits of agreement at higher values.
· Clinical Threshold Consideration: As noted by the authors, this behavior aligns with previously reported inter-method variability among commercial AMH immunoassays and should be considered when interpreting results close to clinically relevant decision thresholds (where confirmatory central lab testing may be warranted).
 

Figure: Bland–Altman analysis for the overall study population (N = 304), demonstrating method difference and mean bias between the Wondfo Finecare™ AMH POCT assay and the reference automated ECLIA platform (Roche cobas 8000 e602) across the complete clinical concentration range (0.1–13 ng/mL).

Designed for Decentralized Fertility Testing

The evaluated AMH assay runs on the Finecare™ FIA Meter II Plus SE, a compact platform optimized for point-of-care fertility assessment:
· Rapid Turnaround: Delivers quantitative AMH results within 15 minutes.
· Wide Dynamic Range: Supports an analytical measuring range of 0.1–16 ng/mL without requiring centralized laboratory infrastructure.
· Evaluated Usability (SKUP Framework): Laboratory personnel reported favorable ease of use, clear operating procedures, good result readability, and minimal training requirements based on the Scandinavian SKUP evaluation framework.
 

Independent Evidence Supporting Clinical Application

The study concludes that the Wondfo Finecare™ AMH POCT test demonstrates acceptable analytical performance, strong correlation with gold-standard laboratory platforms, and exceptional usability. While concentration-dependent proportional bias exists in the low-to-mid range, these findings define clear guidelines for incorporating rapid AMH testing into fertility clinics, outpatient facilities, and reproductive health centers.

 

Explore Wondfo Finecare™ Reproductive Health Solutions

To learn more about Wondfo Finecare™ analyzers and our quantitative AMH testing solution:
Wondfo Finecare FIA Meters (Point of Care Testing)
 
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