The test is intended for self-testing when symptoms of SARS-CoV-2/Influenza A/Influenza B/ADV/RSV viruses are present.

Accuracy >99%

Results in 15 minutes

Sample: Nasal swab

The problem

Viral infections can cause fever, cough, fatigue, muscle and/or body aches, headache, sore throat, and difficulty breathing.

  • Test cassette;
  • Sterile Anterior Nasal Swab;
  • Lysis Buffer and Dropper (430 µL);
  • Bio-Safety bag;
  • Instructions for use;
  1. Allow the kit components to reach room temperature. Wash your hands and dry them well.
  2. Check the expiry date on the box or sealed foil pouch. Check that the contents of the test kit have not been used before (these disposable materials cannot be reused). Do not open the foil pouch until you are ready to use it.
  3. Peel off the foil wrap of the sample tube and place it in the test tube rack.
  4. Sample collection: open the sterile swab package according to the opening instructions. Do not touch the soft tip of the swab, pull it out holding only the plastic handle.
  5. Insert the swab into the nasal cavity (up to 2.5 cm deep). Try to collect all nasal secretions. Carefully rotate the swab in a circle against the inside of the nasal cavity at least 5 times. Repeat the procedure in the other nasal cavity using the same swab.
  6. After the sample has been taken, place the soft tip of the swab in the sample preparation tube containing the extraction buffer and swirl the swab near the inner wall of the tube 10 times.
  7. Squeeze the tube 5 times at the tip of the swab to allow the sample to be released into the buffer solution in the tube. Raise the swab above the buffer solution, squeeze the outer walls of the tube and squeeze the swab repeatedly to ensure that as much of the test solution as possible remains in the tube.
  8. Dispose of the tampon in a bio-waste bag. Place the dropper on the tube.
  9. The cartridge has two sample wells. Add 4 drops (approximately 100 μL) to each. Evaluate the results after 15 minutes. Do not evaluate the results after 20 minutes. Note: If an air bubble has formed during the drip, add another drop of sample to the well.
  10. Dispose of all used components in a bio-waste bag and close it tightly.

Negative result:

If only quality control line C is visible and the test line is not visible, the sample is free of SARS-CoV-2, influenza A, influenza B, ADV, RSV antigens, or the concentration of these antigens is below the limit of detection, resulting in a negative result.

 

Positive result:

  • SARS-CoV-2 positive result: if the control line and the SARS-CoV-2 line (nCoV) appear at the same time, this means that the SARS-CoV-2 antigen has been detected and the result is positive.
  • Influenza A positive result: if the control line and the Influenza A test line (Flu A) appear at the same time, it means that the sample has detected the Influenza A antigen and the Influenza A result is positive.
  • Influenza B positive result: if the control line and the Influenza B test line (Flu B) appear at the same time, it means that the sample has detected the Influenza B antigen and is Flu B positive.
  • ADV positive result: if the control line and the adenovirus line (ADV) appear at the same time, it means that the ADV antigen has been detected in the sample and the adenovirus result is positive.
  • RSV positive result: if the reference line and the respiratory syncytial virus (RSV) line appear at the same time, it means that the sample is positive for respiratory syncytial virus antigen and RSV.

If quality control line C and more red lines appear, the sample contains one or more pathogens.

 

Invalid result:

If the reference line does not appear, the result is invalid and a new test must be performed.

Ingredients

  • Test cassette;
  • Sterile Anterior Nasal Swab;
  • Lysis Buffer and Dropper (430 µL);
  • Bio-Safety bag;
  • Instructions for use;

Instructions

  1. Allow the kit components to reach room temperature. Wash your hands and dry them well.
  2. Check the expiry date on the box or sealed foil pouch. Check that the contents of the test kit have not been used before (these disposable materials cannot be reused). Do not open the foil pouch until you are ready to use it.
  3. Peel off the foil wrap of the sample tube and place it in the test tube rack.
  4. Sample collection: open the sterile swab package according to the opening instructions. Do not touch the soft tip of the swab, pull it out holding only the plastic handle.
  5. Insert the swab into the nasal cavity (up to 2.5 cm deep). Try to collect all nasal secretions. Carefully rotate the swab in a circle against the inside of the nasal cavity at least 5 times. Repeat the procedure in the other nasal cavity using the same swab.
  6. After the sample has been taken, place the soft tip of the swab in the sample preparation tube containing the extraction buffer and swirl the swab near the inner wall of the tube 10 times.
  7. Squeeze the tube 5 times at the tip of the swab to allow the sample to be released into the buffer solution in the tube. Raise the swab above the buffer solution, squeeze the outer walls of the tube and squeeze the swab repeatedly to ensure that as much of the test solution as possible remains in the tube.
  8. Dispose of the tampon in a bio-waste bag. Place the dropper on the tube.
  9. The cartridge has two sample wells. Add 4 drops (approximately 100 μL) to each. Evaluate the results after 15 minutes. Do not evaluate the results after 20 minutes. Note: If an air bubble has formed during the drip, add another drop of sample to the well.
  10. Dispose of all used components in a bio-waste bag and close it tightly.

Results

Negative result:

If only quality control line C is visible and the test line is not visible, the sample is free of SARS-CoV-2, influenza A, influenza B, ADV, RSV antigens, or the concentration of these antigens is below the limit of detection, resulting in a negative result.

 

Positive result:

  • SARS-CoV-2 positive result: if the control line and the SARS-CoV-2 line (nCoV) appear at the same time, this means that the SARS-CoV-2 antigen has been detected and the result is positive.
  • Influenza A positive result: if the control line and the Influenza A test line (Flu A) appear at the same time, it means that the sample has detected the Influenza A antigen and the Influenza A result is positive.
  • Influenza B positive result: if the control line and the Influenza B test line (Flu B) appear at the same time, it means that the sample has detected the Influenza B antigen and is Flu B positive.
  • ADV positive result: if the control line and the adenovirus line (ADV) appear at the same time, it means that the ADV antigen has been detected in the sample and the adenovirus result is positive.
  • RSV positive result: if the reference line and the respiratory syncytial virus (RSV) line appear at the same time, it means that the sample is positive for respiratory syncytial virus antigen and RSV.

If quality control line C and more red lines appear, the sample contains one or more pathogens.

 

Invalid result:

If the reference line does not appear, the result is invalid and a new test must be performed.

Instruction leaflet

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