In Vitro Diagnostic Industry in China - Clinical Chemistry VIII

2.2.5 Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Assay Kit (Rate Method)

Zybio obtained the registration certificate and patent for the Lp-PLA2 assay kit (rate method) in 2015. The performance of the kit can reach the international leading level by using an innovative substrate design and reagent formula. The product is the first self-developed enzymatic assay kit that has been approved. Zybio continuously improves and optimizes product performance and stability, and is dedicated to better clinical application of Lp-PLA2. In 2018, Zybio firstly reported the reason for the consistency of the results of enzymatic hydrolysis method and quality method, which was consistent with the conclusion published by Topbas C in Clinical Chemistry. This further verified the scientificity of the Lp-PLA2 enzymatic determination method and it became the standard method for Lp-PLA2 detection.

The "inflection point of domestic products" is constantly approaching in the biochemical diagnosis industry. Although the in vitro diagnostic industry still needs continuous improvement in the field of raw materials, the process of domestic substitution has been accelerating for the midstream of the entire biochemical manufacturing industry. Particularly, the domestic biochemical reagents have replaced more than 70% of the imported reagents, and most Grade III Level A hospitals have used the domestic biochemical reagents. The domestic enterprises are constantly improving with the technological innovation.

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