Adenovims (ADV) Antigen Rapid Test (Immunochromatographic Assay)

Primary DI

06974521001768

Basic UDI-DI Code

B-06974521001768

Reference

SUPL023025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

The kit is used for the in vitro qualitative detection of adenovirus (ADV) antigens in human nasopharyngeal swabs and oropharyngeal swabs. For professional use only. This kit is applicable to auxiliary diagnosis of ADV infection. The test results are for clinical reference only and cannot be used solely as the basis for the diagnosis or exclusion of cases. Pandemic adenovirus in China mainly includes ADV-3, ADV-7, ADV-11, ADV-14 and ADV-55, of which ADV-3 and ADV-55 are the most common. In recent years, ADV-55 have caused increasingly frequent respiratory infectious diseases in troops and schools. Adult severe pneumonia pandemic arising from ADV-55 has been reported continuously, which indicates that ADV-55 infection has become a major cause of adult community-acquired pneumonia. ADV mainly causes respiratory diseases, but it also can cause infectious diseases to digestive tract, urinary tract, eyes and myocardium, and so on. Generally, B1, C and E adenoviruses mainly cause respiratory diseases and B2 mainly causes urinary system infection. In case of RSV infection, human's immune system can stimulate humoral immune and cellular immune responses and gradually control injection and eliminate the virus. When viremia occurs in the early infection stage (1-3d), ADV can be detected out of serum and nasal and guttural secretions of patients.

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