H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G GFAP assay for the fully automated, random-access LUMIPULSE® G immunoassay systems. The Research Use Only (RUO) assay is now available in the United States, and it will be available in Japan, Europe and other regions* as of September this year. The Chemiluminescent Enzyme Immunoassay (CLEIA) test allows for the quantitative measurement of glial fibrillary acidic protein (GFAP) in human plasma and serum in just 35 minutes.
C-luminary Biotech was founded in 2018 and is headquartered in Chengdu, China, with a research and development center in Suzhou and industrial platforms in Sichuan and Hunan, is a professional enterprise engaged in the research, development, production, and sale of in vitro diagnostic products.
At the early stage of development of chemiluminescence in China, many manufacturers have gone through a road of breakthrough of unique items in the market, and of course, the expansion of some items has also provided important value to clinical practice.
If Chinese chemiluminescence would eventually replace imported products completely, it must ensure the accuracy and reliability of the test results. In addition to the improvement of equipment system and methodology, the accuracy of results will involve two very core competitions in the future.
The analyzer will develop in two directions as per different customer needs and application scenarios.
Immunoassay is the largest subdivision in in vitro diagnosis and is in rapid develop-ment, in which chemiluminescence has gradually replaced enzyme-linked immuno-sorbent assay as the mainstream immune diagnosis in China.
Chemiluminescence immunoassay reagent has become the mainstream product in the field of immunoassay and is widely used in clinical in vitro diagnosis due to its advantages such as high sensitivity, good specificity, a wide range of measurements, high degree of supporting automation, and excellent precision and accuracy.
There are multiple classification criteria for immunodiagnostic techniques, the most commonly used of which are classified into labeled immunoassays and non-labeled immunoassays according to whether they are labeled or not.
By rapid development of China's immunoassay, the market share of chemiluminescence has gradually expanded. Immunoassay diagnosis was already the largest sub-field of the market in China, currently accounting for about 25%.
The development of modern immunoassay benefited from the development of labeled immunological technology. The clinical problems, which classical immunoassay could not solve, can be solved by modern immunoassay.
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