First in China: All 8 Coagulation Factors Multi-center Studies Have Been Completed

A series of multi-center studies headed by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS) in collaboration with multiple medical institutions including Jiangxi Provincial People's Hospital, Anhui Chest Hospital, and Zhejiang Hospital of Traditional Chinese Medicine, has been successfully completed. The studies focused on the eight key coagulation factors (II, V, VII, VIII, IX, X, XI, XII) assay reagent kits developed by SUNBIO. They systematically established reference intervals for the Chinese population and comprehensively validated the clinical diagnostic performance of the kits, providing a robust data foundation for the precise diagnosis and standardized treatment of hemorrhagic disorders.

Establishment of Chinese Population Reference Intervals for Coagulation Factors

The studies extensively covered multiple regions across China, incorporating a total of 1,556 samples from healthy individuals aged 19 to 79 years. Gender distribution was fully considered, ensuring sufficient representativeness of the population. Using standardized testing procedures and rigorous data analysis methods, the studies established reference intervals applicable to the Chinese population, providing reliable diagnostic benchmarks for clinical laboratories.

Clinical Performance Verification Advances Precise Diagnosis of Rare Bleeding Disorders

Accurate detection of coagulation factors activity levels is critical for the diagnosis and treatment of coagulation-related disorders. This series of studies included a total of 3,677 clinical samples, covering patients from 0.5-year-old infants to elderly patients up to 100 years old, comprehensively evaluating the diagnostic efficacy of the reagent kits across different age groups and clinical conditions. The results demonstrated that the eight coagulation factors assay reagent kits developed by SUNBIO exhibit excellent clinical diagnostic value and performance.

With the completion of all eight multi-center clinical studies on coagulation factors, SUNBIO has become the first company in China to offer the most comprehensive menu for coagulation factors testing, further solidifying its leading position in the field of thrombosis and hemostasis diagnostics.