Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）

Dénomination commerciale

Alpha Fetoprotein (AFP) Detection Kit （Magnetic Solid Phase Chemiluminescent Immunoassay）

Code d'IUD-ID

06974969980069

IUD-ID de base

B-06974969980069

Numéro de référence/catalogue

100 Tests/kit（DR1016-2）

Entité d'attribution

GS1

Catégorie de risque

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

It is used to quantitatively detect the concentration of Alpha Fetoprotein (AFP) in human serum in vitro. It is mainly used for dynamic monitoring of malignant tumor patients to assist in judging the disease process or treatment effect. Not for cancer screening in the general population. Alpha Fetoprotein (AFP) was first discovered and recorded in fetal serum by Bergstrand and Czar in 1956. Alpha Fetoprotein is a single-chain polypeptide glycoprotein with a molecular weight of about 70KD. It’s physicochemical properties and amino acid composition are similar to albumin. The synthesis of AFP first occurs in the fetal liver and yolk sac, and it is secreted into fetal serum, reaching a peak at about 13 weeks of gestation, and then gradually decreasing. Alpha Fetoprotein (AFP) was first demonstrated by Tatarinov in 1964 as a human tumor-associated protein, and subsequent studies have confirmed that elevated AFP levels are common in several malignant diseases, such as primary liver cancer and non-seminoma testicular cancer. It has been reported that more than 70% of patients with primary liver cancer are accompanied by elevated serum AFP levels. AFP levels gradually decrease while the patient is in clinical recovery, and failure to decrease AFP levels after surgery is likely to indicate the presence of residual tumor. Usually before being clinically proven, tumor recurrence is often accompanied by elevated AFP levels.

URL des informations complémentaires

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0102039001ALPHAFETOPROTEIN

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