Rapid SARS-CoV-2 Antigen Test Card

Rapid "Self" antigen test from anterior nasal swab (anterior part of the nose)
Result in 15 minutes
Easy execution

Registered with the Ministry of Health
Min. Sal. No. 2089498

CE 0123 marking,
Certificate N °: V90613170006 Rev.00 dated 01/04/2021

Diagnostic sensitivity: 96.77%
Diagnostic specificity: 99.20%

The SARS-CoV-2 Rapid Antigen Test is a single-step immunochromatographic in vitro test. It is designed for the rapid qualitative detection of SARS-CoV-2 virus antigens on anterior (anterior part of the nose) nasal swab specimens from individuals with suspected COVID-19 infection within the first seven days of symptom onset. The SARS-CoV-2 Rapid Antigen Test should not be used as the sole basis for diagnosis or to rule out a SARS-CoV-2 infection.
Children under 14 must be looked after by an adult.

Important information before proceeding
1. Read these instructions carefully.
2. Do not use the product after the expiration date.
3. Do not use the product if the pouch is damaged or the seal is broken.
4. Store the test at 4 to 30 ° C in the original sealed pouch. Do not freeze.
5. The product must be used at room temperature (15 ° C to 30 ° C). If the product has been stored in a colder environment (temperature below 15 ° C), leave it at normal room temperature for 30 minutes before use.
6. Treat all specimens as potentially infectious.
7. Inappropriate or inaccurate specimen collection, storage, and transport may lead to inaccurate test results.
8. Use the swabs provided in the package to ensure optimal test performance.
9. Correct sampling is of paramount importance for performing the test. Be sure to collect enough sample material for analysis (nasal secretions) with the swab, especially for the nasal sample collection in the front.
10. Blow your nose several times before taking the sample.
11. Samples should be examined as soon as possible after collection.
12. Introduce the drops of sample to be analyzed into the well (S) only.
13. Too many or too few drops of the Extraction Solution can make the test result invalid or incorrect.
14. Children under 14 must be supervised by an adult.

Limits:
1. The test is to be used only for the qualitative detection of SARS-CoV-2 virus antigens in anterior nasal (anterior part of the nose) swab specimens. The exact concentration of SARS-CoV-2 virus antigens cannot be determined with this test.
2. Correct sampling is essential. Failure to follow the procedure can lead to inaccurate test results. Inadequate specimen collection, storage, freezing and thawing can lead to inaccurate test results.
3. If the viral load of the sample is below the detection limit of the test, the test may give a negative result.
4. As with all diagnostic tests, a final clinical diagnosis should not be based on the result of a single test, but should be made by the physician following evaluation of all clinical and laboratory results.
5. Regardless of SARS-CoV-2, a negative result does not rule out a viral infection and should be confirmed by molecular diagnostics if COVID19 is suspected.
6. A positive result does not exclude packaging with other pathogens.
7. The SARS-CoV-2 Rapid Antigen Test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARS-CoV-2 Rapid Antigen Test is dependent on viral load and may not correlate with other diagnostic methods performed on the same specimen.
8. Users should perform sample testing as quickly as possible after collection and in any case within two hours of collection.
9. The sensitivity of nasal or oropharyngeal swabs may be less than that of nasopharyngeal swabs. The nasopharyngeal swab method should be performed by healthcare professionals.
10. Monoclonal antibodies that have undergone slight amino acid changes in the target epitope region may fail to detect or less sensitively detect the SARS-CoV-2 virus.
11. The amount of antigen in a sample may decrease with increasing disease duration. Samples taken after the 5th-7th day of illness are more likely to be negative than an RT-PCR test.
12. The kit has been verified with the swabs provided. Using other swabs can lead to false negative results.
13. The validity of the SARS-CoV-2 Antigen Rapid Test Cassette has not been proven for identification / confirmation of tissue culture isolates and should not be used in this function.
14. The cross-reactivity of the test cassette was evaluated by testing viruses and other microorganisms. Definitive concentrations of viruses and other microorganisms are documented in the Cross-Reactivity study. The viruses and other microorganisms listed there, with the exception of the human SARS coronavirus, have no influence on the test cassette test results. Positive test results do not exclude packs with other pathogens. Positive results can occur in case of SARS-CoV-2 infection.

Preparation
- Prepare a flat, clean and dry surface.
- Check the contents of the package.
- Make sure nothing is damaged or broken.
- Take the timer
- Blow your nose several times before taking the sample.
- To wash hands.

Disposal
The test kit can be disposed of with normal household waste in accordance with applicable local regulations.

Method
1 Open the extraction solution.
CAUTION: Open it away from your face and be sure not to spill the liquid.
2 Pour the entire contents of the extraction solution into the extraction tube.
ATTENTION: avoid contact between the two containers.
3 The swab is in the sealed package. Locate the soft fabric tip.
4 Open the swab package and carefully remove the swab.
ATTENTION: try not to touch the soft fabric tip with your hands.
5 Carefully insert the swab into one nostril. The tip of the swab should be inserted no less than 2.5 cm deep from the edge of the nostril. Rotate the swab along the mucosa inside the nostril to ensure that both mucus and cells are collected. Rotate the swab 3-4 times. Leave the swab in the nostril for a few seconds. Repeat the procedure with the same swab in the other nostril.
ATTENTION: this operation can be unpleasant. Do not insert the tampon deeper if you feel severe resistance or pain.
6 Insert the swab with the sample into the extraction tube. Now rotate the swab three to five (3-5) times. Leave the swab in the extraction buffer solution for 1 minute.
7 Press the extraction tube with your fingers trying to remove the solution from the swab as best you can, while withdrawing and discarding the swab.
8 Place the cap with the dropper on the extraction tube.
9 Leave kit components at room temperature before testing. Open the pouch and remove the test cassette. Place the test cassette on a flat, straight surface.
CAUTION: After opening, the test cassette must be used immediately.
10 Rotate the extraction tube and pour 3 drops (75 μl) of the sample onto the well (S) by gently pressing the extraction tube.
ATTENTION: avoid the formation of air bubbles in the well (S).
11 The result is displayed after 15-20 minutes.
Warning: after more than 20 minutes the result may be wrong.
The used product can be disposed of with normal household waste in accordance with applicable local regulations.

Interpretation of test results
Positive: If two colored lines appear within 15-20 minutes, a line in the control area (C) and a line in the test area (T), the test is valid and positive. The result is considered positive, no matter how faint the colored line is in the test area (T). A positive result does not exclude packaging with other pathogens.
Negative: If within 15-20 minutes a colored line appears in the control area (C) but no colored line is seen in the test area (T), the test is valid and negative. A negative result does not rule out a SARS-CoV-2 viral infection and should be confirmed by molecular diagnostics if the presence of COVID-19 is suspected. Invalid: If no colored line appears in the control area (C) within 15-20 minutes, the test is invalid.
Repeat the test with a new test cassette.

Kit contents:
Device on individually packaged box
Sterile nasal swab
Extraction tube
Reaction solution
Instructions for Use

Format
1 box with 1 test.