Milk analysis using milk analyzers in a standardized setting (MAMAS) study: A multicentre quality initiative

Area of Science:

• Neonatal nutrition
• Clinical laboratory science
• Infant feeding

Background:

• Human milk analyzers are vital for precise macronutrient measurement in breast milk, crucial for targeted infant fortification and preventing growth issues.
• Many devices lack essential calibration, validation, and quality assurance, potentially compromising results.

Purpose of the Study:

• To evaluate measurement quality across different human milk analyzers.
• To determine if individual calibration curves enhance device accuracy and precision.
• To assess the long-term stability of measurements under good clinical laboratory practice (GCLP) guidelines.

Main Methods:

• A multi-center study involving 15 devices (Unity SpectraStar and MIRIS Human Milk Analyzer) across North America and Europe.
• Analysis of identical breast milk samples in three phases: initial performance assessment, 6-month stability/quality control, and monthly ring trials.
• Inclusion of calibration samples, quality control batches, and ring trial samples to assess device performance over time.

Main Results:

• Significant variations in fat, protein, and lactose measurement accuracy and precision were observed among analyzers.
• Individual correction algorithms demonstrated potential to improve measurement accuracy.
• Long-term stability varied by device, with larger batch volumes yielding more robust repeated measurements.

Conclusions:

• Observed measurement variations have clinical implications for infant nutrition prescriptions and research outcomes.
• Adherence to GCLP is critical for ensuring accurate macronutrient measurement by human milk analyzers, aligning with standards for other medical devices.