Multi-Center Clinical Study Results Released for the Second Series of Coagulation Factors (V、VII、XI、XII)

Following the successful completion of a multicenter clinical study on coagulation Factors II and X, a new series of studies focusing on Factors V, VII, XI and XII has been concluded. This subsequent phase of research was conducted by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS), in collaboration with Jiangxi Provincial People’s Hospital, Anhui Chest Hospital, and Zhejiang Provincial Hospital of Traditional Chinese Medicine, evaluating the assay kits developed by SUNBIO. The studies aimed to establish Chinese population reference intervals and assess the clinical performance of these kits.

Establishment of Chinese Population Reference Intervals for Coagulation Factors V, VII, XI, and XII kit

This multi-center study encompassed eastern, northern, central, and southern regions of China. The cohort included samples from individuals aged 19 to 79 years, with consideration given to gender distribution, ensuring strong population representativeness. Based on data from 756 samples, the research team established the following reference intervals for the four coagulation factors: Factor V (FV): 72.4%–135.0%; Factor VII (FVII): 63.6%–134.9%; Factor XI (FXI): 69.5%–129.6%; Factor XII (FXII): 52.7%–146.2%.

Clinical Performance Verification Advances Precise Diagnosis of Rare Bleeding Disorders

Accurate measurement of coagulation factor activity is crucial for diagnosing corresponding deficiency disorders and provides vital support for clinical decision-making. The clinical performance evaluation involved 1,320 patient samples covering a wide age range from 0.5 to 96 years. Results confirmed that the four assay kits exhibit excellent clinical diagnostic value.

With the completion of these multicenter clinical studies for the six coagulation factors (II, V, VII, X, XI, and XII), SUNBIO has made a significant breakthrough in the field of diagnostic reagents for rare bleeding disorders. This achievement lays a solid foundation for the standardized diagnosis and treatment of these conditions.