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

3.6 Construction of Quality System

The standardization and quality control of thrombus and hemostasis testing methods is to perform reasonable management, testing, and assessment of the quality level of the techniques, operations, instruments, reagents, and specimens of thrombus and hemostasis experiments by using standardized physical, chemical, and biological methods according to the statistical principles, so as to eliminate errors and improve the precision, accuracy, and reliability of experiments. The purpose of standardization and quality control is to provide a reliable basis for clinical diagnosis and treatment, improve the efficiency and value of basic research on thrombosis and hemostasis, and contribute to population health surveys and the establishment of a normal reference range of hematology testing. It can reflect the medical and research levels of thrombosis and hemostasis in a country, a region, and a research institution.

Factors affecting hemostasis testing mainly include specimens (collection method, storage method, and transportation method), reagents (anticoagulant ratio, detection reagent type), equipment (semi-automated, fully automated), and technology (proficiency, interference factors), etc. Due to the particularity of thrombosis and hemostasis tests, there is still no mature standardized protocol for the detection of platelet function, anticoagulation factors, and fibrinolytic components. There are clear specifications in only three test items of prothrombin time (PT) and activated partial thromboplastin time (APTT) by the International Committee for Standardization of Hematology (ICSH), the International Committee on Thrombosis and Hemostasis (ISTH), or the National Committee for Clinical Laboratory Standards (NCCLS). The standardization of coagulation testing is conducive to improving the accuracy and scientificity of coagulation testing and establishing the coagulation item traceability system. However, for the particularity of coagulation items, researchers should work hard in the future.

In conclusion, although foreign-funded companies occupy a large market advantage in the blood coagulation industry, one of the fastest-growing segments of IVD, with the emergence of domestic enterprises, they will overcome the difficulties and occupy a certain market share in the blood coagulation industry.

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