In Vitro Diagnostic Industry in China - Clinical Chemistry V

2.2 Biochemical Reagent Products and Development of New Products and New Technologies in 2019-2020

Against the background of the current rapid development of life science and technology, with the development of clinical biochemical test technologies, there are more and more product categories and test items in the biochemical detection platform. Moreover, in order to occupy the market, various biochemical diagnostic companies continuously improve the existing biochemical test menu and launch new test items, and develop new products with new methodologies to achieve cross-platform detection.

Firstly, the realization of other in vitro diagnosis in the biochemical platforms: Carcinoembryonic antigen assay kit is a product of tumor markers, and most of which follows the chemiluminescence detection method. BSBE has developed the biochemical products with the same sensitivity and accuracy as chemiluminescence. The α2-macroglobulin assay kit is a special protein product, which is detected by a special protein analyzer, or detected on a biochemistry analyzer. The 25-hydroxyvitamin D assay kit launched by BSBE has realized the transformation from three reagents to two reagents, and successfully realized the transformation from mass spectrometry to the detection on the biochemical platform.

Secondly, the development of new technologies based on the biochemical plat-forms: In recent years, with the increasing number of patients with major chronic diseases in China, more and more commonly used clinical drugs and new drugs have been used. However, a part of drugs will remain in the patient's blood after administration and metabolism. This part of drugs at a certain concentration will seriously affect the testing of various biochemical items of the patient's blood. The in vivo concentration of these drugs to be tested is extremely low. BSBE has realized the detection of low-concentration small molecule drugs on the biochemical platform, and developed the test kits of carbamazepine, glycocholic acid, phenytoin, valproic acid, etc.

In addition, the enterprises mainly engaging in the biochemical business work hard in the following two aspects: one is to enhance the product quality constantly in the original test items; and the other is to continuously develop new test items brought by the technological innovation. With the application of the latex-enhanced immunoturbidimetry and the enzyme immunoassay amplification, the sensitivity of biochemical test items is greatly improved. Representative products applied in the biochemical technology platform in 2019-2020 are as follows:

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