Description
Quick test for detecting SARS-CoV-2 nucleocapsidic antigens in front nasal swab samples. Only for in vitro diagnostic use. For the autotest.
The quick test for SARS-CoV-2 antigen is a lateral flow test for the qualitative detection of the nucleocapside antigen from SARS-CoV-2 in front nasal swab samples directly from suspected COVID-19 individuals within the first seven days from the beginning of the symptoms. The test can be used to analyze samples of asymptomatic subjects. It does not distinguish between SARS-CoV and SARS-CoV-2. The results relate to the identification of the SARS-CoV-2 antigen. This antigen is generally found in the samples taken from the upper respiratory tract during the acute phase of the infection. Positive results indicate the presence of viral antigens, but to determine the state of the infection the anamnesi and other personal diagnostics are necessary. The positive results do not exclude the presence of bacterial infections or simultaneous infection with other viruses. The pathogen detected may not be the exact cause of pathology. Negative results obtained are subject to symptoms that have appeared for over seven days should be treated as negative odds. If necessary, look for confirmation through a molecular analysis. Negative results do not exclude SARS-CoV-2 infection. The quick antigenic test for SARS-CoV-2 is intended for use as a support for the diagnosis of SARS-CoV-2 infection. The usability of autonomous tests carried out by individuals who are not 18 years old has not been determined. It is recommended that children under 18 are tested by an adult.
The quick test for the SARS-CoV-2 antigen is a test for detecting the nucleocapsidic antigen from SARS-CoV-2 in human front nasal swab samples. The test results are visually read in the range of the next 15-30 minutes, depending on the presence or absence of colored lines. A coloured line with procedural control function will always appear in the area of the control line, to indicate that a sufficient sample volume has been inserted and that the absorption of the membrane has occurred.
Clinical benefits
Sensitivity: 97.1% (95% CI: 93.1%-98,9%)
Specificity: 99.5% (95% CI: 98.2%-99,9%)
Accuracy: 98.8% (95% CI: 97.6%-99,5%)
LoD: 1,6x10² TC₅₀/ml

Mode of use
Preparation
Wash or disinfect your hands. Make sure they are dry before starting the test. Before using the quick antigenic test kit for SARS-CoV-2, read the instructions. Check the printed expiration date on the film envelope.
Sample withdrawal
Autonomous withdrawal: the autonomous sampling with nasal swab can be performed by those who are 18 years old. Children under 18 must be run by a parent or legal guardian. Follow the local guidelines for sampling by children.
Analysis procedure
1. Remove the aluminum sheet from the top end of the extraction pad.
2. Insert the pipe into the hole on the kit box. Or place the tube in the tube support.
3. Open the box at the end of the stick. Do not touch the absorbent tip of the tampon with your hands.
4. Insert the whole tampon absorbent tip into a nostril. Using with a slight rotation, push the pad less than 2.5 cm from the edge of the nostril.
5. Rotate the swab 5 times touching slightly inside the nostril. Extract the tampon and insert it into the other nostril. Repeat Step 4.
6. Extract the tampon from the nostril.
7. Insert the swab into the tube, making a circular motion for 30 seconds.
8. Turn the swab 5 times, compressing at the same time the side of the tube.
9. Extract the swab while compressing the tube.
10. Secure the dropper tip firmly on the extraction pad test containing the sample. Mix carefully by turning or touching the bottom of the tube.
11. Gently compress the test tube and deliver 4 drops of solution in the sample well.
12. Read the result when the timer has reached 15-30 minutes. Don't read if it's been 30 minutes.
Interpretation of results
Positive: Both the control line (C), and the test line (T). It means the SARS-CoV-2 antigen was detected. Any line present, even very weak, in the area of the test line (T) must be considered positive. The positive result indicates a very high probability that COVID-19 infection is in place. Please contact your doctor or local health care provider immediately. Follow the local self-isolation guidelines. A PCR test must be performed.
Negative: Only the control line (C) and no test line (T). It means that no SARS-CoV-2 antigen has been detected. A negative result of the analysis indicates that it is unlikely that it is currently affected by COVID-19. Continue to comply with all applicable rules and protection measures when contacting other persons. There may be an infection in place even if the test is negative. If you have the suspicion, repeat the test after 1 or 2 days, since the coronavirus cannot be accurately detected at all stages of the infection.
Invalid: The control line (C) does not appear. The most probable reasons for the invalid result are insufficient sample volume or incorrect procedure. Reread the instructions and repeat the test with a new cassette. If the test results continue to be invalid, please contact your doctor or a center running the COVID-19 test.

Warnings
Before testing, carefully read the leaflet in the quick antigenic test package for SARS-CoV-2. Non-compliance with indications can result in inaccurate test results. Do not use the test after the expiration date on the envelope. Do not eat, drink or smoke before and during the test. Do not use the test if the envelope is damaged. All tests used, samples and potentially contaminated material must be disposed of according to local regulations. Humidity and temperature can adversely affect results. The test line for a sample with high viral charge may appear within 15 minutes or even before, when the sample exceeds the test line area. The test line for a sample with low viral charge may appear within 30 minutes. Do not collect the nasal swab sample in case of bleeding from the nose. Wash your hands thoroughly after use. If the extraction pad accidentally comes in contact with the skin or eyes, rinse with large amounts of water and consult a doctor if necessary. Don't freeze.
Just for self-test. The test should only be used for detecting the nucleocapsidic antigen from SARS-CoV-2 in front nasal swab samples. The intensity of the test line is not necessarily related to the SARS-CoV-2 viral charge in the sample. A false negative could be obtained if the antigen concentration in a sample was lower than the test detection limit or if the sample was incorrectly collected. The results of the analysis must be observed in the face of other clinical data available to the doctor. The positive results do not exclude joint infections caused by other pathogens and do not distinguish between SARS-CoV and SARS-CoV-2. The negative results of the test do not exclude the presence of other viral or bacterial infections. A negative result obtained on a subject with symptoms that have appeared for more than seven days should be taken as a likely negative and, if necessary, verified through molecular analysis.

Conservation
Store in a cool and dry place, between 2°C-30°C. Keep away from light.
Validity of whole packaging: 24 months.

Format
Contains:
1 test cassette;
1 test of the extraction pad;
1 disposable tampon;
1 bag for waste;
1 leaflet.

Cod. L03-118M5