Multi-Center Clinical Study Results on Coagulation Factors II and X Testing

A multi-center clinical trial for the Coagulation Factor II and X Assay Kits, developed by Shanghai Sun Biotech Co., Ltd., has been successfully completed. The study was led by the Institute of Hematology & Blood Diseases Hospital, China Academy of Chinese Medical Sciences, in collaboration with Jiangxi Provincial People's Hospital, Anhui Chest Hospital, and Zhejiang Provincial Hospital of Traditional Chinese Medicine. The study focused on establishing reference intervals specific to the Chinese population and conducting a comprehensive clinical performance assessment for both kits.

Establishing Chinese Population Reference Intervals for FII/FX

This multi-center study covered eastern, northern, central, and southern regions of China. A total of 400 participants aged 20 to 78 years were enrolled, ensuring a balanced gender distribution and strong population representativeness. Based on the collected data, the reference intervals were established as 72.9%–134.4% for Coagulation Factor II and 70.0%–133.6% for Coagulation Factor X.

Clinical Performance Study: Supporting Standardized Diagnosis of Rare Bleeding Disorders

Accurate measurement of coagulation factor activity levels is crucial for the definitive diagnosis of coagulation factor deficiencies. It also provides as an essential basis for clinical decisions, including monitoring factor replacement therapy, guiding anticoagulant reversal, and conducting preoperative assessments. This study analyzed 617 samples aged from 0.67 to 98 years. The results demonstrated that both assay kits offer excellent diagnostic performance and significant clinical utility.