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Chinese Pediatric Reference Intervals for Serum Cortisol on IMMULITE 2000
Ling Li Wang1, Li Yue Zhang2, Hui Yan Wang1
1Unit of Laboratory Medicine, Second Hospital Affiliated to Wenzhou Medical University, Wenzhou, China.
Insights
This study establishes crucial pediatric reference intervals for serum cortisol in healthy Chinese children aged 4-18 years. These new reference ranges improve diagnostic accuracy for pediatric endocrine conditions in this population.
Area of Science:
- Endocrinology
- Clinical Chemistry
- Pediatrics
Background:
- Accurate interpretation of serum cortisol levels is vital for pediatric diagnosis.
- Existing reference intervals are primarily based on Caucasian populations, limiting their applicability to other ethnicities.
- Establishing population-specific reference intervals is essential for precise clinical decision-making.
Purpose of the Study:
- To develop and establish pediatric reference intervals for serum cortisol levels in a healthy Chinese population.
- To address the lack of specific cortisol reference ranges for Chinese children.
- To improve the accuracy of pediatric endocrine disorder diagnosis in China.
Main Methods:
- Serum cortisol levels were measured in 1,143 healthy Chinese children (4-18 years) using the IMMULITE 2000 Immunoassay System.
- Participants were stratified into age groups (4-8, 9-12, 13-15, 16-18 years) following CLSI guideline EP28-A3c.
- Blood samples were collected in the morning (7-9 a.m.) and afternoon (1-3 p.m.) to account for diurnal variations.
Main Results:
- Specific pediatric reference intervals for serum cortisol were established for different age groups: 4-8 years (49.6-323.7 nmol/L), 9-12 years (70.9-395.3 nmol/L), and 13-15 years (90.1-448.7 nmol/L).
- For adolescents aged 16-18 years, distinct reference intervals were determined for morning (118.2-464.7 nmol/L) and afternoon (71.4-446.7 nmol/L) cortisol levels.
- These intervals provide a baseline for interpreting cortisol test results in Chinese children.
Conclusions:
- The study successfully established pediatric reference intervals for serum cortisol in Chinese children, enhancing diagnostic capabilities.
- These population-specific intervals are critical for accurate clinical interpretation and management of endocrine conditions in pediatric patients in China.
- Further research is recommended to validate these intervals across different analytical systems and diverse pediatric populations.
Abstract:
Clinical interpretation of the test results for cortisol based on continuous reference intervals with appropriate partitions improves pediatric diagnosis; however, these values are available only for Caucasians. To develop the pediatric reference intervals for Chinese population, we examined the serum cortisol levels in 1,143 healthy Chinese children aged 4-18 years (566 boys and 577 girls), using an IMMULITE 2000 Immunoassay System (Siemens Healthcare GmbH). Phlebotomy was performed at 7-9 a.m. for 284 boys and 287 girls and at 1-3 p.m. for the others. They were divided into four age groups according to the Clinical and Laboratory Standards Institute guideline EP28-A3c, with the last group further stratified according to sampling time. Separate reference intervals of 49.6-323.7, 70.9-395.3, and 90.1-448.7 nmol/L were established for children aged 4-8, 9-12, and 13-15 years, respectively. Further, reference intervals of 118.2-464.7 and 71.4-446.7 nmol/L were established for morning and afternoon cortisol levels, respectively, in children aged 16-18 years. Further studies are necessary to transfer and validate these reference intervals in other analytical systems and pediatric populations, and to allow for broader applications.
