SARS-CoV-2 Antigen IVD Kit SALIVA Whitelist CE Certification
Product Description
This kit is used for in vitro qualitative detection of COVID-19
antigen in human saliva samples.
Mechanism Of Reaction
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.
Interpretation Of Results
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.
Precision
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 |
| In vitro diagnostic medical devices | 
| Storage temperature limit |
| Manufacturer |
| Authorized representative in the European Community |
 | Date of Manufacture |  | Use by date |
 | Do not reuse |  | Consult instructions for use |
| Batch code |
| Meet the requirements of EC Directive 98/79/EC |
