YY/T 1729-2020 "Fungus (1-3)-β-D-Glucan Test" formulated by Era Biology was approved by NMPA on July 9, 2020 and officially released. The standard will be formally implemented on June 1, 2021.
The preparation of this standard was organized by the National Medical Clinical Laboratory and the In Vitro Diagnostic System Standardization Technical Committee (TC136) , and it was officially launched in April 2017. Beijing Gold Mountainriver Tech Development Co., Ltd., a subsidiary of Era Biology, as the first drafter, cooperates with Beijing Medical Device Inspection Institute, Beijing Medical Device Technology Evaluation Center, National Health Commission Clinical Testing Center, and Genobio Pharmaceutical Co., Ltd. (a wholly-owned subsidiary of Era Biology), jointly drafted and formulated the standard. As the first industry standard in the field of fungus rapid detection, which is led by an enterprise, the standard stipulates the accuracy, linearity, blank limit, detection limit, and repeatability, bottle-to-batch difference, batch-to-batch difference, analysis specificity, stability requirements and test methods, etc., of the fungus (1-3)-β-D-glucan test. This standard is applicable to kits for the quantitative determination of fungal (1-3)-β-D glucan in human serum and plasma by spectrophotometry based on the principle of chromogenic method.
As a leading company in the domestic fungal rapid inspection industry, Era Biology not only fills the domestic gap in one fell swoop, but also developed the first rapid diagnostic product for invasive fungal diseases, and is also committed to the continuous upgrading of product standards. For more than 20 years, we have been positioned as an industry leader, guided by market standardization, constantly advancing with the times, striving for perfection, and continuing to pursue excellence. The formulation of this standard has shown the strength of the leading brand in the fungus testing to the industry. The promulgation of this standard can effectively standardize the quality of products in the industry and enhance the reputation of the fungal testing industry in the entire field of in vitro diagnostics.
Era Biology will actively implement the standard publicity and implementation work, realize standardized production of enterprise products, and enhance the competitiveness of the entire enterprise with high-quality products. At the same time, technical personnel will be organized to conduct standard publicity and implementation training for clinical and laboratory users in major hospitals.
While formulating industry standards and standardizing the development of the industry, Era Biology has successfully registered the first domestic quality control products for kits (including freeze-dried products at three concentration points of high, medium and low in order to improve the quality control of clinical laboratories, covering a comprehensive range ) to provide professional quality control products for clinical laboratories and further improve the quality evaluation system of medical laboratories.
In the future, Era Biology will continue to play to the technological advantages of the industry leader, actively participate in the formulation of industry-related product standards, contribute its own strength to the standardization process of the in vitro diagnostic industry, and escort the safe development of China's medical industry!