Product Description
REAGEN This kit is used for in vitro qualitative detection of SARS-CoV-2
antigen in human oropharyngeal swabs and nasopharyngeal swab
samples.
Mechanism Of Reaction
REAGEN This kit adopts the detection principle of 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 the SARS-CoV-2 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
SARS-CoV-2 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.
Kit Contents, Storage And Shelf Life
The REAGEN SARS-CoV-2 antigen IVD kit SWAB has the capacity for 20
determinations. The shelf life is 24 months when the kit is
properly stored.
| Kit Contents | Storage |
COVID-19 Test Card Pouch (contains 1 x desiccant) |
4~30℃ (Dry and Dark) |
| Sample Extraction Buffer |
| Extraction Tube |
| Sterile Swab |
| Manual |
Warnings And Precautions
1. This kit is only used for in-vitro auxiliary diagnosis and must
be operated in strict accordance with the instructions.
2. Please check the validity period and package integrity of the
kit before use. If the package of the test card is damaged or
exceeds the validity period, it cannot be used.
3. Must follow the time of determination and judgment result.
4. It is recommended to use it immediately, for one-time use only;
the test card should be tested within 30 minutes after being taken
out of the package to avoid prolonged exposure of the test card to
the air.
5. The kit can be stored at room temperature. Beware of moisture,
light, heat, heavy pressure, and freezing.
6. It is recommended that the waste or remaining samples generated
during the test be soaked in a lipid solvent such as ether, 75%
ethanol, chlorine-containing disinfectant, peracetic acid and
chloroform for virus inactivation treatment.
7. The test results of this kit are for clinical reference only.
The clinical diagnosis of the disease should be comprehensively
considered in conjunction with its symptoms, signs, medical
history, other laboratory tests and treatment responses.
