Establishment of reference intervals for serum amylase and lipase: a large sample study based on Chinese healthy...

Area of Science:

• Pediatric Endocrinology
• Clinical Chemistry
• Biomarker Research

Background:

• Accurate reference intervals for serum amylase and lipase are crucial for diagnosing pediatric pancreatic and other gastrointestinal diseases.
• Existing reference intervals may not accurately reflect age- and sex-specific variations in healthy children.
• Prospective studies are needed to establish reliable pediatric reference ranges.

Purpose of the Study:

• To establish age- and sex-specific reference intervals for serum amylase and lipase in a large cohort of healthy Chinese children.
• To provide updated and more accurate diagnostic benchmarks for pediatric clinical practice.
• To investigate the influence of age and sex on serum amylase and lipase concentrations in children.

Main Methods:

• Prospective investigation of 6466 healthy Han children aged 1 month to 18 years.
• Serum amylase and lipase concentrations measured using the VITROS 5600 integrated system.
• Nonparametric 95% percentile intervals used to define reference ranges.

Main Results:

• Amylase reference intervals showed distinct age-related patterns: rapid increase (1 month–5 years), slight decrease (5–12 years), slow increase (12–18 years).
• Lipase concentrations exhibited sex differences after age 1, with higher levels in females than males.
• Lipase reference intervals were stratified into 2 divisions for males and 3 for females, showing an overall upward trend in both sexes.

Conclusions:

• Established age- and sex-specific reference intervals for serum amylase and lipase in healthy Chinese children.
• These new reference intervals offer improved diagnostic accuracy for pediatric diseases involving these enzymes.
• Provides a foundation for better clinical interpretation and patient management in pediatric care.