Respiratory syncytial virus ( RSV ) Antigen Rapid Test (Immunochromatography Assay)

Primary DI

06974521001966

Basic UDI-DI Code

B-06974521001966

Reference

SUPL022025

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 respiratory syncytial virus (RSV) antigens in human nasopharyngeal swabs and oropharyngeal swabs. For professional use only. This kit is applicable to auxiliary diagnosis of RSV infection. The test results are for clinical reference only and cannot be used solely as the basis for the diagnosis or exclusion of cases. RSV belongs to pneumovirus, and its nucleic acid is single minus strand RNA; it has no segments but envelope with two types of glycoprotein furcella on the surface: G protein (90K) and F protein (F1-48K, F2-26K). There is tegument protein M protein on the internal surface of the envelope. RSV is classified into two subtypes of RSV-A and RSV-B according to protein genotype characteristics. Human RSV is a kind of infectious viruses that can cause diseases to human. RSV infection mainly prevails in spring and winter and can break out in the densely populated places easily. Isolation of virus is the most important diagnostic method for RSV infection, RSV carrier has not been identified, and a definite diagnosis can be made through separating virus using monoclonal antibody of the screened anti-RSV fusion protein (F protein). RSV is a major pathogen that causes acute lower respiratory infection to infants worldwide and features high morbidity, wide spreading range and latent period of 3-7 days. People infected with RSV may have rhinitis, dry cough and mild fever and even trachitis and pneumonia in severe case. 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 virusemia occurs in the early infection stage (1-3d), the virus 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).