In Vitro Diagnostic Industry in China - Immunoassay X

5.1 Future Development of Automatic Chemiluminescence Immunoanalyzer

The analyzer will develop in two directions as per different customer needs and application scenarios.

First, the analyzer has an increasingly faster speed of stand-alone detection, and is more automatic, informationized, intelligent, modular, and pipelined. The end customers who need to form a total laboratory workflow from biochemical, luminescent immunoassay, and other platforms have extended from ultra-large laboratories to large and medium-sized laboratories, and products will be more widely used in special chemiluminescence pipeline of small and medium-sized medical institutions. In order to realize the overall breakthrough in third-level hospitals, the Chinese chemiluminescence should meet the high-throughput and multi-item needs in the future, and in addition, it should meet the intelligent pipeline solution integrating laboratory biochemical immunity. Behind the pipeline is the stability of the manufacturer's system, as well as the flexible combinations to meet the needs of different hospitals. Second is the instrument miniaturization combined with individual reagent. In order to meet the needs of rapid, on-site, or bedside detection in primary medical institutions, clinical laboratories, or special items, the chemiluminescence POCT products will have better repeatability and sensitivity than traditional dry fluorescence POCT products; and there will also be a broad application prospect for miniaturized chemiluminescence instrument combined with individual detection reagent.

5.2 Subdivisional Item Innovation and Substitution To Be Strengthened

Presently, the market share of chemiluminescence detection is in the order of tumor markers, thyroid functions, hormones, infectious diseases, cardiac markers, metabolism, anemia, etc. Import brands have an absolute dominant position in the detection of tumor markers, thyroid functions, and hormones. With proven technology, domestic brands have gradually joined the competition in terms of tumor markers, thyroid functions, and hormones. Not only the regular items have been gradually accepted in clinical practice, but also the differentiated competition of some new special items has resulted in good results. For example, special tumor markers such as CA242 have well supplemented the imported brands.

For other special items, due to the product layout and enhanced supervision on registration in China of imported brands, domestic brands have been given a good opportunity. For example, for autoimmune items, imported brands can only detect a few items in the field of chemiluminescence, which is insufficient to support clinical application, and the traditional membrane strips and enzyme immunoassay methods have poor precision, specificity and accuracy. Several Chinese brands have successively launched a complete autoimmune menu and achieved good application effect. However, traditional chemiluminescence technology cannot support the simultaneous detection on autoimmune multiple targets, and has insufficient detection throughput. It is expected that the subsequent bead-based chemiluminescence detection technology may have unique advantages in the detection on autoimmune multiple targets.

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