Pediatric reference intervals in China (PRINCE): design and rationale for a large, multicenter collaborative...

Area of Science:

• Clinical Chemistry
• Pediatric Laboratory Medicine
• Reference Interval Establishment

Background:

• Current pediatric reference intervals (RIs) in China lack accuracy and do not account for age and gender variations.
• Existing RIs are often based on outdated or inappropriate methodologies, impacting clinical decision-making for children.

Purpose of the Study:

• To establish and validate accurate, age- and gender-specific pediatric reference intervals (RIs) for 31 common laboratory measurands in China.
• To address the critical need for reliable RIs in Chinese pediatric healthcare.

Main Methods:

• A large-scale, multicenter, cross-sectional study involving 14,490 healthy children and adolescents up to 19 years old.
• Data collection across 10 children's hospitals and one university pediatric department.
• A pilot study of 602 children was conducted to refine methodology and assess feasibility.

Main Results:

• The pilot study revealed significant age-dependency and gender-based differences in certain laboratory measurands.
• Feasibility challenges were identified, including recruitment of very young children and infant blood sample collection.
• The pilot results confirmed the necessity of the PRINCE project.

Conclusions:

• The PRINCE project is essential for developing reliable pediatric RIs in China.
• Methodological adjustments based on pilot findings are crucial for the study's validity and transparency.
• Accurate RIs will improve diagnosis and treatment for pediatric patients in China.