Establishment of Age-Specific Reference Intervals for 16 Coagulation Parameters in Chinese Children Using Sysmex CN-6000 Analyzer: A Cross-Sectional Study
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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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