Infection Disease Influenza A+B Antigen Rapid Test with CE certificate Test Device

For professional in vitro diagnostic use only

【INTENDED USE】

The Influenza A+B Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

Sensitivity, Specificity and Accuracy

The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for the Influenza A+B Rapid Test Device (Swab/Nasal Aspirate). Specimens were considered positive if RT-PCR indicated a positive result. Specimens were considered negative if RT-PCR indicated a negative result Nasal Swab Specimen.

Nasal Swab Specimen

Throat Swab Specimen

Nasal Aspirate Specimen

【SUMMARY】

Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract .It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus. 1 Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder. The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus. 2 Cell culture has limited clinical utility, as results are obtained too late in the clinical course for effective patient intervention. Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a newer method that is generally more sensitive than culture with improved detection rates over culture of 2-23%.3 However, RT-PCR is expensive, complex and must be performed in specialized laboratories. The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) qualitatively detects the presence of Influenza A and/or Influenza B antigen in nasal swab or throat swab or nasal aspirate specimens ,providing results within 15 minutes. The test uses antibodies specific for Influenza A and Influenza B to selectively detect Influenza A and Influenza B antigen in nasal swab, throat swab or nasal aspirate specimens.