Diagnostic Kit for Alpha-fetoprotein (AFP) (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521003243

Basic UDI-DI Code

B-06974521003243

Reference

SUPF034025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is suitable for in vitro quantitative detection of the concentration of alpha-fetoprotein (AFP) in human serum, plasma or whole blood samples. Alpha-fetoprotein (AFP) is a glycoprotein with a molecular weight of 70,000. It is mainly synthesized by normal fetal liver, followed by a small amount of synthesis in the yolk sac, gastrointestinal mucosa, and kidney. It starts to be synthesized at 6 weeks of gestation and reaches the highest level at 12-14 weeks. . AFP in serum dropped to normal one year after delivery. Under normal circumstances, it mainly exists in embryonic tissues and disappears quickly after birth. If it reappears in adult serum, it suggests hepatocellular carcinoma or gonad embryonic cancer. In addition, AFP can also be measured in pregnancy, active liver disease, secondary liver cancer, and a few cancers of the digestive tract. The main related tumors of AFP are hepatocellular carcinoma and germ cell carcinoma. Other related tumors include embryonic cell carcinoma, ovarian teratoma, gastric cancer, biliary tract cancer, pancreatic cancer, etc. Some benign diseases include hepatitis (AFP generally <300ng/mL), liver cirrhosis, enteritis, and hereditary tyrosinemia will also increase; it may increase temporarily during pregnancy. The diagnostic criteria for primary liver cancer is AFP>400ng/mL, lasting for more than one month, it can be combined with clinical diagnosis of liver cancer.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).