CTK Biotech, USA Influenza A/B Rapid 25 Test (strip)

The OnSite  Influenza A/B Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of Influenza A virus, including H5N1 and H1N1, and Influenza B virus in nasal/throat/nasopharyngeal swab or nasopharyngeal aspirate/wash specimens.

• Single test that reliably detects the most common types of influenza – type A and B virus, including H1N1 (swine flu) and H5N1 (bird flu).
• High quality CE marked and approved for sale in Europe.
• Comfortable and durable with a small, soft swab tip that is ideal for use with children.
• Initial patient care action can begin during patient’s visit as results are available within 10 minutes.
• Sensitivity: 94.1%, Relative Specificity: 97.4%
• Shelf Life 24 Month

Each kit contains:

• Individually sealed foil pouches containing:
  • One cassette device
  • One desiccant
• Sample extraction tubes, each containing 0.3 mL of extraction buffer
• Sterile swabs, each sealed in a plastic-paper pouch
• One package insert (instruction for use)

TEST PRINCIPLE  : The OnSite Influenza A/B Rapid Test is a lateral flow chromatographic immunoassay. The test strip consists of: 1) a burgundy colored conjugate pad containing anti-Influenza A and B antibody conjugated with colloidal gold (antibody conjugates) and 2) a nitrocellulose membrane strip containing two test lines (T1 and T2 lines) and a control line (C line). The T1 line is pre-coated with anti-Influenza A antibody, the T2 line is pre-coated with anti-Influenza B antibody, and the C line is pre-coated with a control line antibody. The Influenza antigen is firstly extracted from the swab specimen with extraction buffer. The antigen extracts contact the test strip and then migrate by capillary action across the test strip. Influenza A antigen, if presents in the extract, will bind to the antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-Influenza A antibodies, forming a burgundy colored T1 line, indicating an Influenza A positive test result. Absence of the T1 line suggests a negative Influenza A result. Influenza B antigen, if present in the extract, will bind to the antibody conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-Influenza B antibodies, forming a burgundy colored T2 line, indicating Influenza B positive test result. Absence of the T2 line suggests a negative Influenza B result. The test contains an internal control (C line) which should exhibit a burgundy colored line of the of the control antibodies regardless of color development on any of the test lines. If the C line does not develop, the test result is invalid and the specimen must be retested with another device.