Description
Rapid immunochromatographic assay for the detection of SARS-CoV-2 virus nucleocapsid protein antigen in human nasal / oropharyngeal swab or salivary collected from asymptomatic or symptomatic individuals suspected of being infected with COVID-19 within the first five days of onset of symptoms.
Latex-conjugated antibodies (Latex-Ab) corresponding to SARS-CoV-2 are dry immobilized at the end of the nitrocellulose membrane strip. SARS-CoV-2 antibodies are bound to the Test Zone (T) and biotin- BSA is connected to the control area (C).
When the sample is added, it migrates by capillary diffusion rehydrating the latex conjugate.
If present in the sample, SARS-CoV-2 antigens will bind to the conjugated antibodies to form particles. These particles will continue to migrate along the strip to the Test Zone (T) where they are captured by SARS-CoV-2 antibodies generating a visible red line.
If no SARS-CoV-2 antigens are present in the specimen, no red line will form in the Test Zone (T). The streptavidin conjugate will continue to migrate by itself until it is captured in the Control Zone (C) by biotin-BSA which aggregates into a blue line, indicating the validity of the test.
The test is used as an aid in diagnosing COVID-19. It is designed to be used for infection screening and auxiliary diagnosis in symptomatic and asymptomatic people.

How to use
Collection and storage of samples
An anterior nasal swab sample can be collected by a doctor or an individual who performs a self-swab.
Collection of samples from children under the age of 12 must be performed by a physician.
Children 12-17 years of age should be under adult supervision if they do the anterior nasal swab on their own.
Adults 18 years of age and older can perform anterior nasal swab on their own.
Follow local guidelines for children's specimen collection.

1. Nasal Swab Sample: Insert a swab into a patient's nostril. The tip of the swab should be inserted up to 2.5 cm (1 inch) from the edge of the nostril. Rotate the swab 5 times along the mucosa inside the nostril to ensure that both mucus and cells are collected. Using the same swab, repeat this process for the other nostril to ensure that an adequate sample is collected from both nasal passages. Remove the swab from the nasal cavity and insert the anterior end of the swab into the extraction tube, touch the bottom of the tube and break the swab at the point of rupture, allow the swab tip to dip into the reagent.

2. Oropharyngeal swab sample: Ask the patient to open their mouth and press the tongue with a tongue depressor if necessary. Insert a swab into the oropharynx and scrape left and right pharyngeal mucosa twice. Remove the swab from the mouth and insert the front end of the swab into the extraction tube, touch the bottom of the tube break the swab at the point of rupture, allow the tip of the swab to dip into the reagent.
To obtain a sufficient amount of sample, it is recommended to use two or more swabs to collect different sample sites and extract all of the sampled buffer into the same tube.
Use the swab provided in the kit, alternative swabs may adversely affect the performance of the assay. Users should check the swab before using it.

3. Saliva sample: Install the saliva collection funnel on the tube, spit the saliva into the tub