ALPHAFETOPROTEIN

Primary DI

06936791010024

Basic UDI-DI Code

B-06936791010024

Reference

JT0101-96

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This reagent kit is applicable for quantitative test of the content of alpha fetoprotein in human serum. Alpha fetoprotein (AFP) is a kind of glycoprotein contained in blood during the embryonic period with a molecular weight of 69 kDa. After a fetus is born, the AFP concentration in the serum starts to decline. For normal adults, the AFP concentration in serum is extremely low (generally < 20 ng/mL) because the liver cells have lost the capacity of synthesizing AFP. The AFP concentration in human serum may rise under some benign and malignant conditions. These conditions include hepatitis, liver cirrhosis, ataxia capillary dilatation, primary hepatocellular carcinoma and some germ cell cancers. Besides, the rise of Maternal Serum AFP concentration (MSAFP) may indicate the existence of open neural tube defects, but is not used for diagnosis of the defect without other tests. This reagent kit is mainly used to dynamically monitor the malignant tumor patients and help determine the disease course and treatment effect. It cannot be used as the basis of early diagnosis or confirmation of malignant tumors and is not suitable for the tumor screening of common population. To accurately evaluate the danger of neural tube defects, it must be combined with the MSAFP test and other examinations, such as ultrasonography, amniography, amniotic fluid acetylcholine grease enzyme and amniotic fluid AFP testing for diagnosis.

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