Description
Rapid antigen detection test SARS-CoV-2 in samples taken from cavities anterior nasal passages.
The SARS-CoV-2 nucleoprotein antigen is generally detected within seven days of the onset of symptoms attributable to coronavirus infection.
A positive result can be used for the rapid treatment of suspected cases of coronavirus infection but cannot be used as the sole basis to confirm or exclude COVID-19 infection.
If the result is negative, there is no no guarantee of exclusion of infection, since If the viral load in the sample is below the detection limit of the test or if the sample has been collected and handled inaccurately, false negative results may be obtained.

Mode instructions for use
Preparation
Bring all test kit components to room temperature (15-30 °C) and wash your hands before testing.
Unscrew the cap and open the tube containing the extraction solution. Do not spill the liquid.
Open the foil pouch containing the test cassette and discard the desiccant. Place the test cassette on a flat surface. It is recommended to use the test cassette within a maximum of half an hour after opening the foil pouch. Perform the test immediately after opening the foil pouch.
Remove the swab from the package.

Sample collection
Insert the swab into the nostril at a depth approximately 2-2.5 cm. The tip of the swab must be inserted completely into the cavity. nasal. If you feel resistance, do not try to push the swab any further.
Rub the inner wall of the nose with a circular motion 5 times (about 15 seconds).
Remove the swab from the nostril and insert it into the other, repeating the same procedure.

Preparation of the sample
After collecting the sample, immerse the swab in the extraction solution contained in the tube and rotate it 10 times. Leave it immersed in the solution for 1 minute.
Using the extraction tube, squeeze the head of the swab as you remove it, in order to collect as much of the swab as possible. possible liquid from the swab. Dispose of the swab.
Close the extraction tube with the appropriate cap and unscrew the dropper on the top.
The sample is ready for testing.

Test Procedure
Add 2, maximum 3, drops of the extraction solution to the sample well (S) on the test cassette.
Read the result after 15 minutes. Do not read the result after 20 minutes.
Do not reuse the test cassette.

Interpretation of results
POSITIVE: two red lines appear, one in the control area (C) and one in the test area (T).
probable that the person has contracted SARS-CoV-2. Please self-isolate and contact your doctor or a coronavirus infection management centre.
A positive result must be confirmed with a PCR test.

NEGATIVE: Only a red line appears in the area of control (C). No red line appears in the test area (T).
unlikely that the person is infected with SARS-CoV-2. A negative self-test result is not a valid test result. however 100% reliable. Continue to respect the distancing and hygiene rules.

INVALID: no red line appears in the control area. The sample volume may not be sufficient or the testing procedure is not suitable. was performed correctly or the test was successful. expired. &` It is necessary to repeat the test.

Warnings
Do not use expired or damaged products. The expiration date is printed on the outer packaging.
Suitable for use by people aged 16 and over. Keep the test kit out of the reach of children, to reduce the risk of accidentally drinking the extraction solution or swallowing small parts.
The test cassette should be used as soon as possible after opening the foil pouch to avoid prolonged exposure to a humid environment, as it this will influence the test results.
At room temperature (15-30 °C) and with humidity lower than 60%, the kit must be used within half an hour of opening. If the humidity exceeds 60%, use immediately after opening the package.
Do not freeze.
An incorrect testing procedure can cause affect the accuracy of the results. Inadequate sample collection, addition of inadequate volume of sample, and failure to adhere to test timing may lead to inaccurate results.
Do not aspirate the sample into your mouth.
During the test, do not smoke, eat , drinking, wearing makeup, wearing or removing contact lenses.
Disinfect spilled specimens or reagents with a disinfectant.
If extraction solution contacts skin or eyes, wash/rinse the affected area with plenty of water. If you notice any irritation, contact your doctor.
After the test, dispose of all used components in a sealable plastic bag, then dispose of it as household waste or waste.
Wash your hands thoroughly after the test.
The test results should not be considered as a final diagnosis, but only as a clinical reference. Judgment should be made based on clinical data such as RT-PCR results, clinical symptoms and prevalence of infectious diseases.
If the antigen content in the sample is lower than the limit of detection, the test result may be negative.
As the disease progresses, the number of antigens in the specimen may increase. diminish. Compared to an RT-PCR test, the result can be more be negative if you test 7 days after the onset of symptoms.
A negative result does not exclude the possibility of of infection. A positive result should not be considered a final diagnosis, but should be evaluated in the context of clinical symptoms and other diagnostic methods.

Storage
Store at a temperature of 4- 30 °C, do not expose to direct sunlight or humid environments.
Validity with intact packaging: 24 months.

Format
The kit contains:
- aluminum pouch containing test cassette and desiccant sachet;
- swab for the collection of samples;
- extraction tube containing the extraction solution, lid and drip cap;
- information leaflet.

Code. HIGHTOPS