According to the results of the basic research, different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.

Sedia Biosciences Corporation, a leading developer of innovative diagnostic tests for infectious diseases, today announced that its Asanté® HIV-1/2 Oral Fluid Test has received Pre-Qualification (PQ) status from the World Health Organization (WHO). This significant achievement enables global procurement and widespread use of this rapid diagnostic test.

Coagulation analyzers are mainly applied for laboratory tests of thrombosis and hemostasis, which can provide valuable indicators for the diagnosis and differential diagnosis of hemorrhagic and thrombotic diseases, detection, and efficacy of thrombolytic and anticoagulant therapy.

Against the background of an increasingly aging global population, the incidence of thrombotic and hemostatic diseases, including cardiovascular diseases, remains high.

According to basic survey results, the existing main problems for coagulation testing include nonunified standardization, insufficient academic knowledge of blood coagulation, less equipment, few testing items, insufficient sample size, insufficient clinical communication, etc.

Implementation of in Vitro Diagnosis of Thrombosis and Hemostasis in the Chinese Market

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.