Description
The kit is suitable for the qualitative detection of the novel coronavirus in nasopharyngeal swab samples or sputum samples. Provides help in diagnosing new coronavirus infection.
It is an immunochromatographic membrane test that uses highly sensitive monoclonal antibodies to detect the SARS-CoV-2 nucleocapsid protein.
The test strip consists of the following parts: i.e. sample pad, reagent pad, reaction membrane and absorbent pad. The reagent pad contains colloidal gold conjugated with 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 Tsu 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
Nasopharyngeal swab :
Slightly tilt the patient's head back to approximately 70°.
Gently insert the swab into one nostril straight back (not straight up), until it reaches the back wall of the nasopharynx - usually half the distance from the corner of the nose to the front of the ear (about 4 to 6 cm or 1 .6 - 2.5 inches). Do not force the swab: if you encounter an obstruction, try the other nostril.
Gently rub and rotate the swab 5 times.
Slowly extract the swab by rotating it.

Remove the foil seal from a sample extraction tube. Place the swab in 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. Discard the swab properly.
Firmly insert the tube cap onto the sample extraction tube.

Bring test devices and samples to room temperature (15-30°C or 59-86°F) prior to testing.
Finger squeeze the bottom of the tube to mix the sample solution.
Take a test card out of 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 sample well on a test card.
Read the result after 15 minutes. The result is considered inaccurate and invalid after 30 minutes.
Do not add sample solution to a used Test Card.

Sputum sample :
Have the patient clear his throat and pass sputum into a paper cup or sputum container.
It is recommended to take a morning sputum sample, before brushing your teeth and having breakfast. If the patient ate or drank immediately prior to specimen collection, rinse the mouth with clean water.

Use the sputum dropper to transfer 0.3 mL of the sputum sample into the sputum extraction tube.