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

2. Current Conditions of Blood Coagulation Analyzers and Reagents in China

As indicated by the release of the China Cardiovascular Health and Disease Report 2019, the current number of cardiovascular patients is 330 million and is still on the rise. Moreover, cardiovascular disease continues to be the leading factor in mortality, with two out of every five deaths resulting from cardiovascular disease. Thrombosis is the most critical factor resulting in cardiac, cerebral and peripheral vascular events, as well as a direct cause of death or disability. In terms of prevention, diagnosis, and prognosis of thrombotic disorders, testing of coagulation items is particularly important.

To better understand the current market use of coagulation at all levels in China, a study has been performed at hospitals of different levels. The study mainly consists of two parts: The first part is to research the use of instruments at medical institutions of different levels (mainly Grade II hospitals) (hereinafter referred to as “basic research”), with the aim of understanding the preferences of hospitals at different levels in terms of instrument selection. In the basic research, a total of 80 hospitals were surveyed, with 65% of the hospitals below Grade III Level A, from 19 provincial regions, including Guangdong, Henan, and Hubei (Fig. 1), including 28 Grade III Level A hospitals, 11 Grade III Level B hospitals, 2 Grade III Level C hospitals, 33 Grade II Level B hospitals, and 6 Grade I Level A hospitals.

The second part mainly focuses on large domestic Grade III Level A hospitals. Given that routine coagulation programs are now relatively common in China, and there may be significant differences in terms of the implementation of some new programs, a total of 13 top Grade III Level A hospitals in China were selected for the study of other coagulation programs (hereinafter referred to as “new program study”), involving Beijing, Shanghai, Tianjin, etc.

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