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Reference Values for 30 Common Biochemistry Analytes Across 5 Different Analyzers in Neonates and Children 30 Days to
Monsurul Hoq1,2, Susan Matthews3,4, Vicky Karlaftis1
1Murdoch Children's Research Institute, Parkville, Australia.
Insights
This study compared biochemistry reference values for children across five analyzer types, finding most variations were within acceptable limits. Harmonized age-specific reference intervals (RIs) can now improve pediatric clinical decisions.
Area of Science:
- Clinical Chemistry
- Pediatric Laboratory Medicine
- Biostatistics
Background:
- Establishing age-specific reference intervals (RIs) for pediatric biochemistry analytes is crucial but challenging due to inter-laboratory variability.
- Interpreting results for individual children across different laboratories is often limited.
- This study addresses the need for harmonized RIs by comparing pediatric reference values across multiple analyzer types.
Purpose of the Study:
- To conduct a head-to-head comparison of reference values and age-specific RIs for 30 biochemistry analytes in children across five different analyzer types.
- To assess the feasibility of harmonizing reference intervals for pediatric clinical chemistry.
- To provide data for improving the interpretation of pediatric laboratory results.
Main Methods:
- Blood samples from healthy children (30 days to <18 years) were analyzed on five analyzer types.
- Mixed-effect regression and quantile regression were used to analyze mean reference values and estimate age-specific RIs.
- Variations between analyzers were compared against established allowable total error limits.
Main Results:
- Variations in age-specific mean reference values between analyzer types were within allowable total error for most analytes.
- Common age-specific reference limits were developed as functions of age and/or sex.
- Analyzer-specific reference limits were also reported for all analytes and analyzer types.
Conclusions:
- The study provides measures for comparing pediatric biochemistry results across analyzer types, supporting RI harmonization efforts.
- Developed equations allow for the integration of age-specific RIs into laboratory information systems.
- This harmonization can enhance evidence-based clinical decision-making for pediatric patients.
Background:
Age-specific reference intervals (RIs) have been developed for biochemistry analytes in children. However, the ability to interpret results from multiple laboratories for 1 individual is limited. This study reports a head-to-head comparison of reference values and age-specific RIs for 30 biochemistry analytes for children across 5 analyzer types.
Methods:
Blood was collected from healthy newborns and children 30 days to <18 years of age. Serum aliquots from the same individual were analyzed on 5 analyzer types. Differences in the mean reference values of the analytes by the analyzer types were investigated using mixed-effect regression analysis and by comparing maximum variation between analyzers with analyte-specific allowable total error reported in the Westgard QC database. Quantile regression was used to estimate age-specific RIs using power variables in age selected by fractional polynomial regression for the mean, with modification by sex when appropriate.
Results:
The variations of age-specific mean reference values between analyzer types were within allowable total error (Westgard QC) for most analytes, and common age-specific reference limits were reported as functions of age and/or sex. Analyzer-specific reference limits for all analytes on 5 analyzer types are also reported as functions of age and/or sex.
Conclusions:
This study provides quantitative and qualitative measures of the extent to which results for individual children can or cannot be compared across analyzer types, and the feasibility of RI harmonization. The reported equations enable incorporation of age-specific RIs into laboratory information systems for improving evidence-based clinical decisions in children.
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