Description
Test intended for the qualitative detection of nucleocapsid protein antigens from Sars-CoV-2 in human nasal swab samples from patients suspected of being infected with covid-19 by a healthcare professional.
It is an aid in the diagnosis of patients suspected of SARS-CoV-2 infection with clinical manifestations and other laboratory tests.
This test is intended for professional and laboratory use only, not for home use. The test result should not be used as the sole basis for the diagnosis or exclusion of SARS-CoV-2 infection.
The results are for the identification of SARS-CoV-2 nucleocapsid protein antigens. The positive result indicates the presence of viral antigens, but clinical correlation with patient history and other diagnostic information are needed to determine the status of the infection. Positive results do not rule out bacterial infections or co-infections with other viruses.
Negative results should be assumed and confirmed by molecular testing if necessary for patient management. Negative results do not rule out covid-19 and should not be used as the sole basis for patient treatment. Negative results should be interpreted in the context of recent exposure and the presence of clinical signs and symptoms related to COVID-19 in the patient.
The test uses recombinant nucleocapsid protein monoclonal I antibodies (N proteins) of Sars-CoV-2 conjugated to colloidal gold coated on the swab, and other N protein monoclonal antibodies II coated on the test line.

How to use
Sample preparation and collection
1. The sample should be a human nasal test sample. Test samples after their collection for optimal test performance. Inadequate specimen collection or improper handling/storage/transport may lead to erroneous results.
2. It is recommended to use a flocked swab with a PP (propylene shaft) as a sterile swab for swab collection.
3. Carefully insert a sterile swab into the nostril with the most discharge under visual supervision. Using a gentle twist, push the swab until it is at the level of the turbinates (less than 2.5cm inside the nostril). Keep the swab in the nasal cavity for 15-30 seconds, swirl the swab 3 times against the nasal wall and then remove it from the nostril. If you have to take a sample from both nostrils, use one swab for each.
4. The nasal swab specimen should be treated with specimen diluent after collection. If testing is delayed, the sample should be returned immediately to a dry, sterilized and tightly sealed plastic tube. It may be held for up to 8 hours at 2°C to 8°C prior to testing.

Test procedure
Read the manual carefully before using the test.
1. Collect the samples.
2. Test paper, sample and reagent must reach room temperature (15°C-30°C) before testing.
3. Remove the test strip from the sealed pouch immediately prior to testing. Label the test strip with the relevant patient or control identification.
4. Place the test paper on a clean table, horizontally.
5. Sample pretreatment:
- take a tube of sample extraction solution, insert the nasal swab sample into the tube and rotate 10 times inside the negative solution to make the sample dissolve in the sample extraction solution as fast as possible;
- crush the tip of the ta