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.

Hangzhou Aichek Medical Technology Co.,Ltd

Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products.

With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of abuse, our research and development team continues to grow.

Based in Hangzhou, the company has long-term cooperation with various R&D institutions in greater China, the United States and Europe, offering the strongest technical support for the development of the company.

We are also a certified ISO and CE organization. By employing strict quality control system, our management team assures exceptional customer service and high quality products.