In terms of the domestic IVD markets of hemostasis and thrombosis, the special testing items are gradually promoted and popularized in domestic medical institutions.

The routine four items are usually used for preoperative examination, but they cannot specifically determine the cause of thrombosis and bleeding in patients.

At present, the coagulation tests are mainly applied for the screening of thrombotic diseases and hemorrhagic diseases, and the routine six items are relatively common in clinical practice (Table 3), mainly including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), D-dimer (D-D), and fibrin (pro) degradation products (FDP).

Thrombotic diseases, in particular cardiovascular and cerebrovascular thrombotic diseases, have become the top cause of death in the population of China, and their incidence has increased, seriously endangering human health.

China has been engaged in the R&D and manufacturing of semi-automatic coagulation analyzers for over a decade, and based on the data from the website of the NMPA, in 2024 and 2025 (as od 15 August), a total of 2 instruments from 2 manufacturers have obtained registration certificates...

Conventional thrombosis and hemostasis diagnostic applications are mainly concentrated on screening for bleeding disorders and diagnosis of bleeding origins, with a relatively narrow scope of application and relatively poor accuracy.