RSV Antigen Rapid Test Cassette (Swab)

Primary DI

06950996002431

Basic UDI-DI Code

B-06950996002431

Reference

GCRSV-502a

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Respiratory Syncytial Virus (RSV) is the most common cause of pneumonia and bronchiolitis in infants and small children. Illness begins most frequently with fever, runny nose, cough, and sometimes wheezing. Diagnosis of RSV is difficult because the initial symptoms can be similar to those caused by other infectious agents such as influenza. Considering that the RSV virus is highly contagious, accurate diagnosis and prompt treatment of patients can have a positive effect on public health. RSV can be detected in human respiratory samples by a variety of methods including tissue culture, immunofluorescent assay and enzyme immunoassay. Although tissue culture is still considered the diagnostic test standard, it requires tissue culture facilities and may take a week to complete. Immunofluorescent antibody-based tests are reasonably sensitive, yet highly dependent on specimen quality and preparation. Enzyme and microparticle-based immunoassays have become one of the most frequently used methods for the detection of RSV. The RSV Antigen Rapid Test Cassette (Swab) is a lateral flow-based immunoassay for the rapid detection of RSV in human respiratory samples. The results from this test are used in combination with other clinical tests and the patients’ conditions to diagnose RSV-associated infections.

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