In Vitro Diagnostic Industry in China - Blood Typing Instruments and Reagents VI

3.2. Technology Development Direction of Blood Typing Instruments

3.2.1. Current Status of Technical Development of Blood Typing Instruments

At present, domestic blood typing instruments have covered microplate, MGT, tube method, and other international mainstream test methods, and they can provide highly automatic and standardized blood typing process, which play an important role in clinical transfusion. Current status of domestic blood typing instruments is mainly characterized by normative, standard and convenient operation; high sensitivity and excellent accuracy; high test efficiency; open reagent; intuitive, stable, reliable, clear and easy to save results; and data management by PC.

Demands for individualized clinical blood transfusion treatment have increased substantially accompanied with rapid development of blood transfusion techniques, which led to increased blood transfusion risks and increasingly more precise requirements on blood transfusion-related test techniques. Fully automatic blood grouping analyzer mainly includes: Computer, Pipetting Arm, Robotic Arm, Incubator, Centrifuge and Reader. Because of these independent modules, The Fully automatic blood grouping analyzer can complete all the processes of blood grouping tests. It can improve results accuracy, improve the traceability of the test processes, reduce the intensity of labor, reduce user errors and reduce the risk of contamination by using fully automatic blood grouping analyzer. Because of these advantages, it can increase the safety of blood transfusion.

Domestic enterprises have made numerous innovations of blood typing instruments. It can be learned from research of domestic patents in the field that related patent applications in China have been continuously active, number of patent applications have maintained the growth momentum, and innovation awareness has been continuously increasing. According to incomplete statistics, as indicated in Fig. 1, the number of domestic blood typing instruments-related patent applications was relatively low before 2008; the number of patent applications experienced certain growth between 2009 and 2012, which indicates domestic enterprises started technological R&D and deployment in the field; it entered the stage of rapid growth from 2014 to 2017, and related domestic products were already introduced to the market for distribution; the number of patent applications reached the peak in 2017 with total number of 36 applications in the whole year; and number of applications reduced somewhat in 2018 and 2019, but the number remained above 20 a year. Hence, it can be seen that our country’s technological studies on automatic blood grouping analyzers are still at the stage of active development; despite the relative reduction, there was still a certain number of applications in 2020 and 2021. Therefore, China’s technological research and development is still at development stage, which is expected to experience a new round of development at the next stage (Fig. 1).

Aikang and Suzhou Hybiome already started technological research on automatic blood grouping analyzer between 2012 and 2014, which allowed them to become relatively early market entrants. In recent years, many excellent domestic device manufacturers made deployment in the field successively and carried out technical researches and innovations, such as Shinva, Zhongshan Bio-Tech and Baso. Technical innovations based on blood grouping analyzer have been put into use, new automatic blood grouping analyzer have been introduced to the market continually, and those products not only covered MG and microplate method, but also included unique product form of test tube-based automatic blood grouping analyzer, which further enriched blood typing instruments and provided users with new experiences.

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