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

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.

【PRINCIPLE】

The Influenza A+B Rapid Test Device (Swab/Nasal Aspirate) is a qualitative, lateral flow immunoassay for the detection of Influenza A and Influenza B nucleoproteins in nasal swab, throat swab or nasal aspirate specimens. In this test, antibody specific to the Influenza A and Influenza B nucleoproteins is separately coated on the test line regions of the test Device. During testing, the extracted specimen reacts with the antibody to Influenza A and/or Influenza B that are coated onto particles. The mixture migrates up the membrane to react with the antibody to Influenza A and/or Influenza B on the membrane and generate one or two colored lines in the test regions. The presence of this colored line in either or both of the test regions indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly

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