In Vitro Diagnostic Industry in China - Diagnosis of Blood and Body Fluids VII

2.2.1 Clinical Test Items

Overview of Routine Coagulation Function Items

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).

Coagulation tests are essential in the examination of patients prior to surgery. Understanding whether the coagulation function of the patient is defective or not can enable the surgeon to prepare accordingly in advance before the operation and avoid accidents as much as possible. Failure to perform the appropriate preoperative tests to identify coagulation deficiencies in patients is likely to result in intraoperative hemorrhage leading to surgical accidents and even death.

Study on implementation of s coagulation items in hospitals

Based on the results of the basic study (Table 4), for the routine four items, the implementation rate of hospitals is greater than 93.75%, indicating that the routine four items are very common in China. The number of surgeries performed in Grade I as well as below Grade I hospitals is relatively low; therefore, coagulation testing is mostly applied for drug monitoring of thrombotic diseases. The huge base of elderly people and high cardiovascular and cerebrovascular morbidity in rural areas of China enables Grade I and below hospitals to obtain a relatively low market as well. In contrast, the other two of the conventional six items, D-D and FDP, exhibited some differences. Among them, 93.75% of the hospitals have performed D-D and only 32.50% of them have performed FDP, indicating that there is still a lack of knowledge of the clinical significance and application of FDP in these hospitals. The main manufacturers within the industry of the above items basically produce and sell or distribute the corresponding products, and the market competition is relatively intensive. Besides the regular six items, some hospitals have also performed other tests such as thromboelastography (TEG) (33.75%), corrective test (17.5%), hematology rheology (27.50%), and coagulation factors (3.75%).

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