EBV ANTIBODIES - OTHER

Primary DI

06936791010031

Basic UDI-DI Code

B-06936791010031

Reference

EB0101-96

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This product is intended for use of the in vitro qualitative testing of EB Virus Zta IgA antibody in human serum.EB Virus is a γ herpesvirus of human B lymphocyte that mainly invades B lymphocytes, with an affinity for human B-lymphocytes, epithelial cells (including parotid ducts, pharynx, and cervix), and glandular cells. Current research has found that EB Virus infection is associated with a variety of human tumors such as nasopharynx cancer and lymphatic cancers. The EB Virus can infect the host cells in two forms, namely dormant infection and lytic infection. When it transforms from dormant infection to lytic infection, the Zta protein product of the early gene BZLF1 will be expressed firstly and the abnormal expression of Zta shows that the EB Virus has ended its dormant status and started the duplication status. Nasopharynx cancer refers to the malignant tumor occurring on the top and side wall of pharyngonasal cavities. A research shows that the EB virus infection is closely related to nasopharynx cancer, and EB virus has been found in most keratocystic squamous cell cancer patients and almost all undifferentiated squamous cell cancer patients. In the classification criteria of International Agency for Research on Cancer (IARC) in 1999, EB virus was classified as class 1 cancerogen and closely related to nasopharynx cancer. Zta protein of EB virus is firstly expressed when the EB virus transforms from dormant infection to lytic infection. If the test result of Zta protein IgA antibody is positive, the risk will rise for patients to develop the nasopharynx cancer. The test results are for clinical reference only and cannot be used alone as a basis for confirming or excluding cases.

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