The EZERTM RSV Antigen Rapid Test is an in vitro diagnostic test for the qualitative detection of Respiratory Syncytial Virus (RSV) nucleoprotein antigens in nasopharyngeal (NP) swab and nasal aspirate samples, using the rapid immunochromatographic method.

RSV is a causative agent of highly contagious, acute, viral infection of the respiratory tract in pediatric and elderly populations. Respiratory syncytial virus is a single-stranded RNA virus. Nearly half of all children become infected with RSV in their first year of life. It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons. Worldwide, it is estimated that RSV is responsible for greater than 30 million cases of LRI in children under 5 years of age each year.

Diagnostic methods for detection of respiratory viruses include viral cell culture, direct fluorescent antibody (DFA), rapid immunoassays, and nucleic acid amplification assays such as the polymerase chain reaction (PCR). Each has been demonstrated to have clinical utility for the detection of respiratory viruses including RSV.

Rapid immunoassays available for specific viruses such as influenza A/B and RSV allow a quick diagnosis so that patients may be appropriately isolated and treated to prevent the nosocomial spread of infections to fellow patients with compromised cardiac, respiratory or immune functions.

Nasopharyngeal Swabbing

Nasal Aspirate Fluid

Throat Swabbing

Limit of Detection

TCID50/mL = 50% Tissue Culture Infectious Dose

Accuracy

Sensitivity: 91.5%

Specificity: 96.8%