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BMJ Paediatr Open. 2017 Aug 31;1(1):e000074. doi: 10.1136/bmjpo-2017-000074. eCollection 2017.

Laboratory reference intervals in the assessment of iron status in young children.

Parkin PC1,2,3,4, Hamid J5, Borkhoff CM1,2,3,4, Abdullah K1,3, Atenafu EG6, Birken CS1,2,3,4, Maguire JL1,2,3,4,5,7, Azad A8,9, Higgins V10, Adeli K9,10.

Author information

1
Division of Pediatric Medicine and the Pediatric Outcomes Research Team (PORT), Hospital for Sick Children, Toronto, Ontario, Canada.
2
Department of Pediatrics, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
3
Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.
4
Clinical Epidemiology and Health Care Research, Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
5
Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.
6
Biostatistics Department, Princess Margaret Cancer Center, University Health Network, Toronto, Ontario, Canada.
7
Department of Pediatrics, St. Michael's Hospital, Toronto, Ontario, Canada.
8
Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, Toronto, Ontario, Canada.
9
Department of Laboratory Medicine and Pathobiology, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.
10
CALIPER Program, Department of Pediatric Laboratory Medicine,, Hospital for Sick Children, Toronto, Ontario, Canada.

Abstract

Objectives:

The primary objective was to establish reference intervals for laboratory tests used to assess iron status in young children using the Clinical and Laboratory Standards Institute guidelines. A secondary objective was to compare the lower limit of the reference interval with the currently recommended cut-off value for haemoglobin and serum ferritin in children 1-3 years of age.

Methods:

Blood samples were obtained from healthy children recruited during scheduled health supervision visits with their primary care physician. For our primary objective, outliers were removed; age partitions were selected and analysis of variance and pairwise comparisons were made between adjacent partitions; reference intervals and 90% CIs were calculated. For our secondary objective, we determined the proportion of children misclassified using the lower limit reference interval compared with the cut-off value.

Results:

Samples from 2305 male and 2029 female participants (10 days to 10.6 years) were used to calculate age and sex-specific reference intervals for laboratory tests of iron status. There were statistically significant differences between adjacent age partitions for most analytes. Approximately 10% of children 1-3 years of age were misclassified (underestimated) using the lower limit of the reference intervals rather than the currently recommended cut-off values for haemoglobin and serum ferritin.

Implications and relevance:

Clinical laboratories may consider adopting published paediatric reference intervals. Reference intervals may misclassify (underestimate) children with iron deficiency as compared with currently recommended cut-off values. Future research on decision limits derived from clinical studies of outcomes is a priority.

KEYWORDS:

decision limits; haemoglobin; iron deficiency; reference intervals; serum ferritin

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