Maccura’s innovative IVD product was approved by NMPA

Recently, an GDF-15 Chemiluminescence Immunoassay kit of Maccura Biotechnology Co., Ltd. obtained the medical certificate. This kit is the first certified Chemiluminescence Immunoassay kit for growth differentiation factor 15 in China.

The human growth differentiation factor 15 (GDF-15) gene is located at 19p12-13.1, and its encoded precursor protein contains 308 amino acids, which becomes a mature protein of 112 amino acids after enzyme digestion, with a relative molecular mass of 25,000. Under physiological conditions, GDF-15 mRNA is only highly expressed in human placental terminal villi cells and prostate epithelial cells, lowly expressed in other tissues such as bladder, pancreas, kidney and lung, and negligibly expressed in myocardial tissue. Pathological conditions such as inflammation, acute tissue injury and oxidative stress can induce its expression. Under pathological conditions, GDF-15 is abundantly expressed in cardiomyocytes and plays a regulatory role in cardiomyocyte structure and apoptosis.

GDF-15, as a member of the cytokine superfamily of transforming growth factor-β, is an independent inflammatory biochemical marker that can reflect cardiovascular function and disease. It has high sensitivity and can detect the increase of GDF-15 in peripheral blood at the early stage of myocardial injury. The level of GDF-15 has reference value for the severity of cardiovascular diseases, the prognosis and risk classification of chronic heart failure, and the bleeding risk of patients with atrial fibrillation after taking anticoagulants.

Maccura’s GDF-15 Chemiluminescence Immunoassay kit is used for the in vitro quantitative determination of GDF-15 concentration in human serum or plasma, and has passed the special approval from NMPA. The product has the advantages of high sensitivity, wide detection range, good marker stability, and strong anti-interference ability. At the same time, the test result can be obtained in 14 minutes, which meets the needs of emergency testing.