REAGEN LLC
REAGEN INC, focusing on ELISA, PCR, and Lateral Flow testing kits including clinical disease detecting kits, food & feed safety test kits, and animal epidemic virus detecting kits in the US for 12
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This kit is used for in vitro qualitative detection of COVID-19 antigen in human saliva samples.
This kit adopts the detection principle of the double antibody sandwich method. The binding pad of the detection card contains colloidal gold-labeled mouse N protein monoclonal antibody I; the detection line (T line) of the nitrocellulose membrane is coated with mouse N protein monoclonal antibody II, quality control line (line C) is coated with goat anti-mouse antibody.
The collected samples are processed by the sample extract and added. During the test, when the extract containing the N protein of COVID-19 is added to the sample hole of the test card, under the action of chromatography, the sample moves to the end of the absorbent paper and first passes through the binding pad. The N protein and colloidal gold labeled mice The source N protein monoclonal antibody I specifically binds and continues to move to the absorbent paper end. When the sample moves to the T line, the N protein bound to the labeled antibody specifically binds to the N protein monoclonal antibody II coated in the T line in a double antibody sandwich mode, and stays at the T line; the remaining liquid continues to absorb water The paper end moves. When it moves to the C line, the mouse N protein antibody I labeled with colloidal gold specifically binds to the goat anti-mouse antibody in the C line. The T line shows a red band, indicating that the COVID-19 antigen is positive. No matter whether the T line is colored or not, the C line should show red. If the C line is not colored, the test is invalid and the sample needs to be tested again.
Negative: A purple-red band, only the quality control line (C line) is colored.
Positive: Two purple-red strips, the detection line (T&A/B) and the quality control line (C line) are both colored.
Invalid results: The quality control line (line C) has no color development, and the test is invalid. It is recommended to take another test card to retest.
The sensitivity of the test kit was 90%-95%, the specificity was 98%-99%, and the accuracy was between 95%-99%
| Symbol | |||
| Symbol | Meaning | Symbol | Meaning |
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| In vitro diagnostic medical devices |
| Storage temperature limit |
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| Manufacturer |
| Authorized representative in the European Community |
| Date of Manufacture | Use by date | ||
| Do not reuse | Consult instructions for use | ||
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| Batch code |
| Meet the requirements of EC Directive 98/79/EC |