Description
The kit is used for the in vitro qualitative determination of SARS-CoV-2 antigens in human anterior nasal swab specimens. It can be used for rapid investigation of suspected COVID-19 cases and can be used as a reconfirmation method for nucleic acid detection in discharged cases.
The test is typically used in the acute phase of infection, when samples are tested within seven days of symptom onset in a suspect population.
It is a qualitative lateral flow immunoassay for the detection of SARS-CoV-2 N protein in human nasal swabs.
In this assay, specific antibody to SARS-CoV-2 N protein is coated separately on the test line region of the test cassette. During the test, the extracted sample reacts with the antibody against SARS-CoV-2 N protein which is coated on particles.
The mixture migrates along the membrane to react with the antibody against the SARS-CoV-2 N protein on the membrane and generates a colored line in the test region. The presence of this colored line in the test area indicates a positive result.
To serve as a procedural control, a colored line will always appear in the control region if the test has been performed correctly.
A positive test result indicates that the sample contains SARS-CoV-2 antigen.
A negative test result does not rule out the possibility of infection.
The test results of the kit are for clinical reference only. It is recommended that a comprehensive patient analysis be conducted based on clinical manifestations and other laboratory tests.
The kit is intended for home use by untrained individuals in a non-laboratory setting.

How to use
Preparation
Equilibrate all test kit components, test cassette, and extraction reagent to room temperature (15-30°C) prior to testing.
Wash your hands with soap and water for at least 20 seconds before testing. If soap and water are not available, use a hand sanitizer solution with at least 60% alcohol.
It is recommended not to clean the nasal cavity before specimen collection, to avoid that the virus content is too low. If the nasal cavity is too wet or dry, clean it and take the sample at least 30 minutes later.

Sample collection
Pull out the extraction tube, open the lid and place the tube in the appropriate tube holder. Take the Extraction Reagent, tear it at the groove and turn it upside down, squeezing the body of the vial, to add the Extraction Reagent into the tube. Do not touch the edge of the tube during this operation.
Remove the swab from the package, being careful not to touch the soft end (the absorbent tip). Insert the swab into one nostril 2-4 cm (1-2 cm in children) until resistance is felt. Using medium pressure, rub the swab slowly into the inside wall of the nostril, in a circular motion, 5 times within 7-10 seconds. Repeat the same procedure with the same swab in the other nostril.
If the swab stick breaks during specimen collection, repeat the collection with a new swab.
When using the swab, users should pay attention to the safety of sampling. Avoid inserting the swab too deep into the nasal cavity, to avoid pain and bleeding.

Sample treatment
Insert the swab into the extraction tube and immerse the entire tip of the swab in the extraction reagent. Rotate