SARS-CoV-2 / Influenza Virus A/ Influenza Virus B Antigen Assay Kit IVD Rapid Test Strip

                                   SARS-CoV-2 / Influenza Virus A/ Influenza Virus B Antigen Assay Kit

[Product Name]

SARS-CoV-2 / Influenza Virus A/ Influenza Virus B Antigen Assay Kit (Immunochromatography)

[Package Specifications]

1 test/kit, 25 tests/kit, 50 tests/ kit, 100 tests/ kit

[Intended Use]

This product is used for the qualitative detection of SARS-CoV-2 antigen / influenza A virus antigen / influenza B virus (FluA/FluB) antigen in human nasal throat swabs or oral throat swabs.

It is only for professional in vitro diagnosis, not for personal use. A positive test result requires further confirmation, and a negative test result cannot rule out the possibility of infection.

The kit and test results are for clinical reference only. It is recommended that the patient’s clinical manifestations and other laboratory examinations be combined for a comprehensive analysis of the condition.

The kit cannot distinguish between SARS-CoV and SARS-CoV-2.

[Test Principle]

The Influenza A/B (FluA/FluB) virus antigen test card adopts latex immunochromatography technology, spraying latex microsphere labeled influenza A virus (hereinafter referred to as "FluA") monoclonal antibody and influenza B virus (hereinafter referred to as " FluB") monoclonal antibody and single C polypeptide-labeled antibody on the binding pad; nitrocellulose membrane is coated with two test lines (A line and B line) and a quality control line (C line). A line is coated with FluA monoclonal antibody to detect FluA virus antigen; B line is coated with FluB monoclonal antibody to detect FluB virus antigen; C line is coated with a single C polypeptide coated antibody. When an appropriate amount of test sample is added to the sample hole of the test card, the sample will move forward along the test card under capillary action. If the sample contains FluA antigen, the antigen will bind to the latex microsphere labeled FluA monoclonal antibody, and the immune complex will form a complex with the coated FluA monoclonal antibody at the A line, showing a red A line, indicating FluA positive. If the sample contains FluB antigen, the antigen will bind to the latex microsphere labeled FluB monoclonal antibody, and the immune complex will form a complex with the coated FluB monoclonal antibody at B line, showing a red B line, indicating FluB positive. If the test lines A and B does not show color, indicating a negative result. The test card also contains a quality control line C, regardless of whether there is a test line, the red quality control line C should show color. If not, it indicates that the test result is invalid and the sample should be tested again. The SARS-CoV-2 antigen test card adopts latex immunochromatography technology, spraying the SARSCoV-2 monoclonal antibody 1 labeled with latex microspheres and single C polypeptide labeled protein labeled with latex microspheres on the binding pad; There are a test line (T line) coated with SARS-CoV-2 monoclonal antibody 2 and a quality control line (C line) coated with a single C polypeptide-coated antibody on the nitrocellulose membrane. When an appropriate amount of the sample to be tested is added to the sample hole of the test 2 / 8 card, the sample will move forward along the test card under capillary action. If the sample contains SARS-CoV-2 antigen, the antigen will bind to the latex microsphere labeled SARS-CoV-2 monoclonal antibody 1, and the immune complex forms a complex with the coated SARS-CoV-2 monoclonal antibody 2 at the T line, showing a red T line, indicating the SARS-CoV-2 antigen positive. If the test line T does not show color and indicating a negative result, it means that the sample does not contain the SARS-CoV-2 antigen.

The test card also contains a quality control line C, regardless of whether there is a test line, the red quality control line C should show color. If not, it indicates that the test result is invalid and the sample should be tested again.