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Paediatric reference intervals are heterogeneous and differ considerably in the classification of healthy paediatric
Anne Bryde Alnor1, Pernille Just Vinholt2
1Department of Clinical Biochemistry and Immunology, Lillebaelt Hospital, Sygehusvej 24, 6000, Kolding, Denmark. anne.alnor@rsyd.dk.
Insights
Published paediatric reference intervals (RIs) vary significantly, leading to inconsistent classification of children's health data. This heterogeneity impacts diagnosis and treatment, highlighting the need for standardized paediatric RIs.
Area of Science:
- Clinical Chemistry
- Paediatric Laboratory Medicine
- Reference Interval Standardization
Background:
- Reference intervals (RIs) are crucial for interpreting paediatric samples, guiding accurate diagnosis and treatment.
- Established guidelines exist for adult RIs, but specific recommendations for paediatric RIs are lacking, leading to the adoption of external RIs.
- This gap poses challenges in paediatric diagnostics.
Purpose of the Study:
- To evaluate differences in published paediatric reference intervals (RIs) and their impact on sample classification.
- To address challenges associated with transferring RIs from external sources into local paediatric populations.
- To assess the transferability and applicability of published RIs for paediatric platelet count, haemoglobin, and white blood cell count.
Main Methods:
- Established a local paediatric cohort (0 days to <18 years) using general practitioner samples.
- Identified transferable RIs from PubMed-indexed studies.
- Applied the Clinical and Laboratory Standards Institute EP28-A3C guideline for RI transference.
- Validated transferred RIs using biological variance-based quality specifications.
Main Results:
- Twelve studies yielded 28 RIs transferred to a local cohort of 20,597 children.
- Significant variations in methodology and results were observed across studies.
- Application of different RIs resulted in classification changes for up to 63% of samples.
- Only one transferred RI was deemed implementable for the local population upon validation.
Conclusions:
- Published paediatric RIs are highly heterogeneous, complicating transferability assessments.
- This heterogeneity leads to substantial discrepancies in classifying paediatric samples, potentially affecting clinical decisions.
- There is a critical need for standardized methodologies in establishing paediatric RIs to ensure accurate patient care.
Abstract:
The aim was to elude differences in published paediatric reference intervals (RIs) and the implementations hereof in terms of classification of samples. Predicaments associated with transferring RIs published elsewhere are addressed. A local paediatric (aged 0 days to < 18 years) population of platelet count, haemoglobin level and white blood cell count, based on first draw samples from general practitioners was established. PubMed was used to identify studies with transferable RIs. The classification of local samples by the individual RIs was evaluated. Transference was done in accordance with the Clinical and Laboratory Standards Institute EP28-A3C guideline. Validation of transference was done using a quality demand based on biological variance. Twelve studies with a combined 28 RIs were transferred onto the local population, which was derived from 20,597 children. Studies varied considerably in methodology and results. In terms of classification, up to 63% of the samples would change classification from normal to diseased, depending on which RI was applied. When validating the transferred RIs, one RI was implementable in the local population. Conclusion: Published paediatric RIs are heterogeneous, making assessment of transferability problematic and resulting in marked differences in classification of paediatric samples, thereby potentially affecting diagnosis and treatment of children. What is Known: • Reference intervals (RIs) are fundamental for the interpretation of paediatric samples and thus correct diagnosis and treatment of the individual child. • Guidelines for the establishment of adult RIs exist, but there are no specific recommendations for establishing paediatric RIs, which is problematic, and laboratories often implement RIs published elsewhere as a consequence. What is New: • Paediatric RIs published in peer-reviewed scientific journals differ considerably in methodology applied for the establishment of the RI. • The RIs show marked divergence in the classification of local samples from healthy children.
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