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Published on: May 10, 2013
Performance of enzymatic creatinine methods in the pediatric concentration range
Hilda Hallander1, Magnus Lindén2,3, Catarina Lindqvist1
1Department of Clinical Chemistry, Halland Hospital, Varberg and Halmstad, Sweden.
Insights
This study evaluated creatinine measurement methods for children, finding varying accuracy in low ranges. Method bias correction needs careful attention for pediatric creatinine levels to ensure reliable kidney function estimates.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Pediatric Medicine
Background:
- Creatinine is a key biomarker for assessing kidney function and glomerular filtration rate in both adults and children.
- Recent studies evaluating creatinine measurement performance specifically within the pediatric concentration range are limited.
- Accurate creatinine measurement is crucial for timely diagnosis and management of kidney diseases in pediatric populations.
Purpose of the Study:
- To assess the measurement performance of commonly used enzymatic creatinine assays on four different platforms (Abbott Alinity, Radiometer ABL800, Roche Cobas, Siemens Atellica) within the pediatric concentration range.
- To compare these platforms against the gold standard isotope dilution mass spectrometry (IDMS) reference method.
- To evaluate the performance of Roche enzymatic methods using control sera from the Nordic Association of Clinical Chemistry.
Main Methods:
- Comparative analytical study involving four automated immunoassay platforms.
- Measurement of creatinine concentrations in pediatric-relevant samples.
- Comparison of results against the isotope dilution mass spectrometry (IDMS) reference method.
- Utilized Nordic Association of Clinical Chemistry control sera for secondary method comparison.
Main Results:
- Significant variability in accuracy was observed among the evaluated creatinine methods at low concentration ranges relevant to pediatrics.
- The relative differences between measurement platforms decreased as creatinine concentration increased, particularly below 75 µmol/L.
- Applying a single absolute factor for method bias correction, as sometimes recommended, may compromise measurement accuracy in the pediatric creatinine range.
Conclusions:
- Current enzymatic creatinine assays exhibit variable performance in the pediatric concentration range.
- Standardization and improved agreement between creatinine measurement methods are necessary for reliable pediatric kidney function assessment.
- Manufacturers and stakeholders must consider the unique challenges of low-concentration creatinine measurements in pediatric patients when developing bias correction strategies.
Abstract:
Creatinine is a widely used clinical biomarker in adult and pediatric patients to estimate kidney function and glomerular filtration rate. There are however few recent studies that have addressed method performance in the creatinine range relevant for children. This study aimed to describe measurement performance in the pediatric concentration range by comparing commonly used enzymatic methods on four platforms: Abbott Alinity, Radiometer ABL800, Roche Cobas and Siemens Atellica, to the reference method isotope dilution mass spectrometry (IDMS). A secondary aim was to compare the Roche enzymatic methods by using dilutions of control sera issued by the Nordic Association of Clinical Chemistry. We found varying accuracy of the creatinine methods in the low concentration range. The relative difference between platforms, in an investigated range below 75 µmol/L, decreased as creatinine concentration increased. Using an absolute factor to correct for method bias as recommended by one of the manufacturers could hamper measurement trueness in the low concentration range. The in vitro diagnostic industry and stakeholders should strive towards creatinine measurement agreeability. Attention to the pediatric concentration range is needed when correcting for method bias.
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