Description
Test kit suitable for the qualitative detection of the novel coronavirus in nasal swab samples.
Provides help in diagnosing new coronavirus infection.
It is a membrane immunochromatographic assay that uses highly sensitive monoclonal antibodies to detect the nucleocapsid protein from SARS-CoV-2.
The test strip consists of the following parts: sample pad, reagent pad, reaction membrane and absorbent pad. The reagent pad contains the orocolloid conjugated to the monoclonal antibody against the SARS-CoV-2 nucleocapsid protein; the reaction membrane contains secondary antibodies to the SARS-CoV-2 nucleocapsid protein. The whole strip is fixed inside a plastic device.
When the sample is added to the sample well, the conjugates absorbed into the reagent buffer are dissolved and migrate with the sample.
If SARS-CoV-2 antigen is present in the specimen, the anti-SARS-CoV-2 conjugate complex and virus will be captured by the anti-SARS-CoV-2 specific monoclonal antibodies coated on the test line region (T).
The absence of the T line suggests a negative result.
To serve as a procedural control, a red line will always appear in the control line region (C) indicating that the appropriate volume of specimen has been added and the membrane wicking effect has occurred.

How to use
Sample collection
Gently insert the entire absorbent tip of the sampling swab into one nostril. Do not insert the swab more than about 2.0 cm into the nose. Do not force the swab, so as not to injure the nose.
Gently rub and rotate the swab in a circular pattern 5 times for at least 20 seconds. Gently remove the swab and repeat the steps in the other nostril.
Remove the foil seal from a sample extraction tube.
Place the swab into the sample extraction tube. Use the swab to mix the solution at least 5 times. Squeeze the Sample Extraction Tube and move the swab up and down at least 3 times to expel any sample solution from the swab.
Dispose of the swab properly.
Firmly insert the tube cap onto the sample extraction tube. Wait for an additional 1 minute to release the viral antigens into the solution.

Test procedure
Return test devices and specimens to room temperature (15-30°C or 59-86°F) prior to testing.
Squeeze the bottom of the tube to mix the sample solution.
Remove a test card from a foil pouch. Place the test card on a table.
Hold the tube upside down vertically. Squeeze the tube to expel 3 drops of sample solution into the loading well on a test card.
Read the result after 15 minutes. The result is considered inaccurate and invalid after 30 minutes.
Do not reload sample solution onto a used Test Card.

Interpretation of results
Positive (+): Red bands appear on both T and C lines in 15-30 minutes. A white band on the T-line should be considered a negative result.

Negative (-): A red band appears on the C line while no red band appears on the T line in 15-30 minutes after sample loading.

Invalid: If there is no red band on the C line, the test result is invalid and the sample should be retested with another test card.

Warnings
Read the instructions carefully