20 Test SARS-CoV-2 Antigen IVD Kit NASAL CE/13485 Whitelist
REAGEN This kit is used for in vitro qualitative detection
of SARS-CoV-2 antigen in human
NASAL 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
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 COVID-19 Antigen Rapid Test Kit has the capacity for 20 and 40 determinations.
The shelf life is 24 months when the kit is properly stored.
REAGEN The sensitivity of the test kit was 94.5%, the specificity was 96.3%, and the accuracy
was between 90%-97.0%.