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Establishment of Age-Specific Reference Intervals for 16 Coagulation Parameters in Chinese Children Using Sysmex
Liping Luo1, Qiuyue Duan1, Juan Huang1
1Department of Laboratory Medicine Shenzhen Children's Hospital Guangdong Shenzhen China.
Insights
Establishing age-specific reference intervals for coagulation parameters in Chinese children is crucial for accurate diagnosis. This study provides comprehensive reference intervals using the Sysmex CN-6000 analyzer for pediatric care.
Area of Science:
- Pediatric Hematology
- Clinical Coagulation
- Developmental Biology
Background:
- The coagulation system in children changes dynamically with age, requiring age-specific reference intervals (RIs).
- Existing RIs may not accurately reflect the hemostatic status of pediatric populations.
- Accurate RIs are vital for diagnosing and managing bleeding and thrombotic disorders in children.
Purpose of the Study:
- To establish comprehensive, age-specific reference intervals (RIs) for 16 coagulation parameters in Chinese children aged 0-18 years.
- To utilize the Sysmex CN-6000 analyzer for precise measurement of routine and specialized coagulation markers.
- To provide essential data for the accurate interpretation of coagulation tests in pediatric patients.
Main Methods:
- A cross-sectional study was conducted on children aged 0 days to 18 years.
- Participants were categorized into six distinct age groups.
- Sixteen coagulation parameters, including routine tests, thrombotic markers, and coagulation factors, were analyzed using the Sysmex CN-6000 analyzer.
Main Results:
- Neonates displayed unique coagulation profiles, with prolonged activated partial thromboplastin time (APTT) and thrombin time (TT), and reduced levels of anticoagulant and coagulation factors.
- Age-dependent trends were observed, including shortening of APTT and progressive increase in factor IX levels into adolescence.
- Novel reference intervals for neonatal D-dimer (D-Di) and Fibrin Degradation Products (FDP) were established, addressing a critical gap.
Conclusions:
- Age-specific reference intervals are essential for the accurate assessment of coagulation status in pediatric populations.
- This study presents the first comprehensive set of RIs for the Sysmex CN-6000 analyzer in Chinese children.
- These established RIs will significantly aid in the diagnosis and management of coagulation disorders in pediatric practice.
Background And Aims:
Children's coagulation system undergoes dynamic changes during development, necessitating age-specific reference intervals (RIs). This study aimed to establish RIs for 16 coagulation parameters in Chinese children aged 0-18 years using the Sysmex CN-6000 analyzer.
Methods:
We conducted a cross-sectional study in children aged 0 day to 18 years who met the inclusion and exclusion criteria. Participants were stratified into six age groups (0-30 days, 1-6 months, 6-12 months, 1-3 years, 3-12 years, and 12-18 years) and blood samples were collected. Routine parameters (APTT, PT, PT-INR, TT, Fibrinogen [Fib]), thrombotic markers (AT-III, D-Dimer [D-Di], Fibrin Degradation Products [FDP]), and coagulation factors (II, V, VII, VIII, IX, X, XI, XII) were analyzed using the Sysmex CN-6000 analyzer. RIs and their 90% confidence intervals (CIs) were calculated using the non-parametric method (for n ≥ 120) or the robust method (for n < 120).
Results:
Neonates exhibited distinct coagulation profiles, including prolonged APTT (22.7 s-46.5 s) and TT (16.2 s-20.8 s), reduced levels of anticoagulant and coagulation factors (e.g., AT-III: 23.1%-91.3%, factor II: 26.5%-77.5%), and elevated fibrinolytic markers (D-Di ≤ 1.41 μg/mL; FDP ≤ 4.44 μg/mL). Age-dependent trends were evident: APTT shortened until adolescence (24.7 s-32.9 s), while factor IX increased progressively (16.3% - 43.2% in neonates vs. 43.6%-108.6% in adolescents). Novel RIs for neonatal D-Di and FDP were established, addressing a critical gap in developmental hemostasis. Sex-specific differences in TT were observed but deemed clinically insignificant.
Conclusion:
Age-specific RIs are essential for children. This study provides the first comprehensive RIs for Sysmex CN-6000 in Chinese children, aiding in the diagnosis and management of coagulation disorders in pediatrics.
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