Description
This rapid test kit is intended for the qualitative detection of SARS-CoV-2 viral nucleocapsid antigens from human anterior nasal secretion specimens from individuals suspected of COVID-19.
It is an immunochromatographic assay that detects SARS-CoV-2 nucleocapsid antigen in samples with the help of the double antibody "sandwich" method.
If virus antigen is present in the sample, it binds to the corresponding colloidal antibody. This complex "migrates" across the membrane and binds to the monoclonal antibody on the test line (T). This creates a visible red line indicating a positive result.
However, if the sample does not contain any antigen, the complex cannot be formed and therefore no red line is generated in the test area (T).
Regardless of whether the sample contains antigen or not, a red line forms in the control area (C).
The positive antigen test result can be used for the early isolation of patients with suspected infection, but cannot be used as the sole method of diagnosing SARS-CoV-2 infection.
Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment.
An additional nucleic acid detection test should be performed in subjects where the antigen test result is positive or negative.

How to use
Before performing the test, leave the test cassette and test components in a room at ambient temperature (15 ° C to 27 ° C).
Place all supplied materials on a clean, dry and level surface.

Open the sealed pouch and remove the test cassette. Place the test well (S) facing up on a clean, dry and flat surface.
Open the tube with the Extraction Reagent and pour the contents into the sample tube and place it on the tube holder.
Gently insert the entire absorbent tip of the swab (approximately 1.5 cm) into the nostril. Slowly rotate the swab 5 times or more in a circular fashion pressing against the inner walls of the nostril. Be sure to collect any nasal drainage fluid that may be on the swab. Gently remove the swab.Use the same swab to repeat the process in the other nostril and slowly withdraw the swab.
Take the tube containing the extraction solution and insert the swab. Mix well and press on the walls of the extraction tube 10-15 times while rubbing the swab.To remove it, push the head of the swab against the top wall of the extraction tube. Release as much liquid as possible. Dispose of the test kit in accordance with applicable local regulations by inserting it inside the BIOHAZARD bag included in the kit which must be well sealed.
Close the sample tube cap. Vertically add 3 full drops of the prepared solution to the well (S) of the test cassette.
Read the result 15-20 minutes after adding the sample. The result obtained after 20 minutes is invalid.

Interpretation of the results
POSITIVE: two colored lines appear. One line appears in the control region (C) and another in the test region (T). The color depth of the test line is not relevant. Any shade of red in the test line is to be considered a positive result.
The test result indicates that SARS-CoV-2 antigen was detected in the sample. Detection of the antigen indicates a high probability of infection with the new coronavirus. Contact immediately