Pediatric within-day biological variation and quality specifications for 38 biochemical markers in the CALIPER cohort
Dana Bailey1, Victoria Bevilacqua, David A Colantonio
1CALIPER program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada;
Insights
This study established biological variation for 38 analytes in children, finding differences from adults and aiding pediatric lab quality management. These findings are crucial for monitoring pediatric health and setting quality standards.
Area of Science:
- Clinical Chemistry
- Pediatric Physiology
- Biomarker Analysis
Background:
- Biological variation studies offer insights into physiological changes within and between individuals.
- Analyte values are critical for patient monitoring and establishing quality specifications.
- Previous research has primarily focused on adult populations, leaving a gap in pediatric data.
Purpose of the Study:
- To evaluate short-term biological variation for 38 chemistry, lipid, enzyme, and protein analytes in a pediatric cohort.
- To assess the impact of age partitioning on interindividual variation in children.
- To compare pediatric biological variation data with established adult values.
Main Methods:
- Collected four plasma samples within 8 hours from 29 healthy children (aged 4-18 years).
- Analyzed samples in three batches using nested ANOVA to determine within-person and between-person biological variation after outlier exclusion.
- Established analytical quality specifications using the Fraser method.
Main Results:
- Established biological variation coefficients and analytical goals for 38 analytes.
- Identified the need for age partitioning in 6 analytes.
- Found that 37% of assays exhibited distinct biological variation characteristics compared to adult values, and reported data for two new analytes.
Conclusions:
- This research is the first to define biological variation and analytical quality specifications for common assays in a pediatric population.
- The findings provide valuable insights into pediatric physiology and support reference change value calculations.
- Results aid in clarifying reference interval appropriateness and developing quality management strategies for pediatric laboratories.
Background:
Studies of biological variation provide insight into the physiological changes that occur within and between study participants. Values obtained from such investigations are important for patient monitoring and for establishing quality specifications. In this study we evaluated the short-term biological variation of 38 chemistry, lipid, enzyme, and protein analytes in a pediatric population, assessed the effect of age partitions on interindividual variation, and compared the findings to adult values.
Methods:
Four plasma samples each were obtained within 8 h from 29 healthy children (45% males), age 4-18 years. Samples were stored at -80 °C and analyzed in 3 batches, with samples from 9-10 study participants per batch. Within-person and between-person biological variation values were established using nested ANOVA after exclusion of outliers by use of the Tukey outlier test. Analytical quality specifications were established with the Fraser method.
Results:
Biological variation coefficients and analytical goals were established for 38 analytes. Age partitioning was required for 6 analytes. Biological variation characteristics of 14 assays (37%) were distinct from adult values found in the Westgard database on biological variation. Biological variation characteristics were established for 2 previously unreported analytes, unconjugated bilirubin and soluble transferrin receptor.
Conclusions:
This study is the first to examine biological variation and to establish analytical quality specifications on the basis of biological variation for common assays in a pediatric population. These results provide insight into pediatric physiology, are of use for reference change value calculations, clarify the appropriateness of reference interval use, and aid in the development of quality management strategies specific to pediatric laboratories.
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