Pediatric reference intervals for 27 routine chemistry analytes in healthy children and adolescents on the Roche cobas pro platform

OBJECTIVES: Accurate interpretation of pediatric laboratory test results requires robust age- and sex-specific reference intervals (RIs). Undertaking studies to establish RIs across the pediatric age range is particularly challenging due to rapid physiological changes during growth and development. While the Roche cobas pro platform is increasingly adopted in clinical laboratories, pediatric-specific RIs for routine chemistry analytes on this system have not yet been established. METHODS: This Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) study aimed to establish pediatric RIs for 27 routine chemistry analytes on the Roche cobas pro c503 analyzer. Analytical performance verification included imprecision, linearity, and method comparison studies. Serum samples from 300 to 500 healthy children and adolescents (birth to <19 years) per analyte were analyzed. Reference intervals were established using nonparametric methods in accordance with CLSI guidelines. RESULTS: All assays met predefined analytical performance criteria, with imprecision <4 %, acceptable linearity across the analytical measuring range, and strong agreement with comparator platforms (r=0.93-0.99). Age-specific partitions were required for 23 of 27 analytes, while sex-specific partitions were necessary for select markers, particularly during adolescence. Electrolytes such as sodium and chloride showed stable RIs across all ages, whereas analytes influenced by growth, bone metabolism, liver function, and muscle mass demonstrated marked age- and sex-related variation. CONCLUSIONS: This study establishes the first comprehensive set of pediatric reference intervals for 27 routine chemistry analytes on the Roche cobas pro platform. These data address a critical gap in pediatric laboratory medicine and provide clinically relevant, platform-specific RIs to support accurate diagnosis and monitoring in pediatric care.