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Published on: August 12, 2016
Pediatric Reference Intervals for Point-of-Care Random Glucose in Healthy Children and Adolescents
Siobhan Wilson1,2, Hannah Earle2, Mary Kathryn Bohn1,2
1CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Insights
This study established pediatric reference intervals for random glucose testing using point-of-care instruments. Results show excellent agreement between devices, aiding accurate clinical decisions in children.
Area of Science:
- Clinical Chemistry
- Pediatric Diagnostics
- Point-of-Care Testing
Background:
- Accurate glucose reference intervals (RIs) are crucial for clinical decision-making in diagnosing and monitoring various conditions.
- Point-of-care (POC) glucose testing is widely used but requires validated RIs for pediatric populations.
- The Canadian Laboratory Initiative on Pediatric Reference (CALIPER) cohort provided a basis for establishing these RIs.
Purpose of the Study:
- To establish pediatric reference intervals for random whole blood glucose using two modern POC instruments.
- To analytically compare the performance of these POC instruments against a laboratory-based analyzer.
- To ensure accurate glucose measurements for pediatric patient care.
Main Methods:
- Recruited approximately 400 healthy children and adolescents (birth to 18 years).
- Collected random venous blood samples and analyzed them on Nova Biomedical StatStrip, Radiometer ABL90 FLEX Plus (POC), and Ortho Vitros 5600 (laboratory).
- Established RIs and performed method comparisons following CLSI guidelines.
Main Results:
- Age-specific RIs were necessary, particularly for infants (0-<1 month, 1-<6 months, 6 months-<19 years).
- Excellent concordance (Pearson r > 0.90) was found between the two POC platforms.
- Good comparability (Pearson r > 0.80) was observed between POC and laboratory-based platforms.
Conclusions:
- Established comprehensive pediatric RIs for random glucose (whole blood) on modern POC systems for the first time within the CALIPER cohort.
- Demonstrated excellent concordance between POC systems and good comparability with laboratory analyzers.
- These findings will support more accurate clinical decision-making in pediatric healthcare.
Background:
Glucose testing at the point-of-care (POC) is routinely used in the diagnosis, prognosis, and monitoring of diabetic states and other clinical conditions. Accurate reference intervals (RIs) are essential in appropriate clinical decision-making. In this study, RIs were established for random glucose (whole blood) in the Canadian Laboratory Initiative on Pediatric Reference (CALIPER) cohort using 2 POC instruments: the Nova Biomedical StatStrip (handheld glucometer) and Radiometer ABL90 FLEX Plus (benchtop instrument). An analytical comparison was also completed between the 2 POC systems and a laboratory-based analyzer (Ortho Vitros 5600).
Methods:
Approximately 400 healthy children and adolescents (birth to 18 years) were recruited with informed consent from community schools or clinics providing care to metabolically stable/healthy children. Random venous samples were collected and run sequentially on the Nova Biomedical StatStrip (whole blood), Radiometer ABL90 FLEX Plus (whole blood), and Ortho Vitros 5600 (serum). RIs and method comparisons between analytical platforms were completed according to CLSI guidelines.
Results:
Significantly different glucose concentrations were observed in infancy, requiring age-specific partitioning (0-<1 month, 1-<6 months, 6 months-<19 years) on all platforms. Excellent concordance was observed between POC platforms (Pearson r > 0.90), with a small negative bias. Good comparability was observed between POC and laboratory-based platforms (Pearson r > 0.80).
Conclusion:
This study established comprehensive pediatric RIs for random glucose (whole blood) on modern POC systems in the CALIPER cohort for the first time. Results demonstrate excellent concordance in glucose values between POC systems and good comparability with a laboratory-based analyzer. These data will assist in more accurate clinical decision-making in pediatric healthcare institutions.
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