Description
Single-phase immunochromatic in vitro test. It was designed for the rapid qualitative detection of SARS-CoV-2 virus antigens on anterior nasal swab samples (front of the nose) of subjects with suspected COVID-19 infection within the first seven days of the appearance of symptoms.
The quick test for SARS-CoV-2 antigen should not be used as the sole basis for diagnosis or to exclude SARS-CoV-2 infection.
Children under 14 years must be assisted by an adult.

Mode of use
Preparation
Prepare a flat, clean and dry surface.
Check the packaging content. Make sure nothing is damaged or broken.
Take the timer. Blow your nose several times before taking the sample. Wash your hands.

Procedure
Open the extraction solution. Open it away from the face and make sure you don't pour the liquid. Pour the entire content of the extraction solution into the extraction test. Avoid contact between the two containers.
The buffer is in the sealed package. Locate the soft tip in fabric. Open the box of the pad and carefully remove the pad. Try not to touch with your hands the soft tip in fabric. Carefully insert the tampon into a nostril. The tip of the pad must be inserted not less than 2.5 cm deep from the edge of the nostril. Rotate the swab along the mucosa inside the nostril to ensure the withdrawal of both mucus and cells. Rotate the tampon 3-4 times. Leave the tampon in the nostril for a few seconds. Repeat the procedure with the same swab in the other nostril.
This operation may be unpleasant. Do not insert the tampon deeper if you feel a strong resistance or pain.
Insert the swab with the sample into the extraction test. Now rotate the pad from three to five (3-5) times. Leave the buffer in the extraction pad for 1 minute. Press the extraction test with your fingers trying to remove the solution from the buffer as best you can, while pulling out and throwing the pad itself. Place the cap with the dropper on the extraction test.
Before testing, leave the kit components at room temperature. Open the bag and remove the test box. Place the test box on a flat and straight surface. After opening, the test box must be used immediately.
Rotate the extraction test and pour 3 drops (75 mcL) of the sample on the well (S) gently pressing the extraction test. Avoid forming air bubbles in the well (S).
The result is displayed after 15-20 minutes. Caution: after more than 20 minutes the result can be wrong.
The product used can be disposed of with normal household waste in accordance with the applicable local rules.

Interpretation of results
- POSITIVE: If within 15-20 minutes two colored lines appear, a line in the control area (C) and a line in the test area (T), the test is valid and positive. The result is to be considered positive, no matter how small the colored line is in the test area (T). A positive result does not exclude co-infection with other pathogenic agents.
- NEGATIVE: If within 15-20 minutes a colored line appears in the control area (C) but no colored line in the test area (T), the test is valid and negative. A negative result does not exclude a viral infection from SARS-CoV-2 and should be confirmed by molecular diagnostics if COVID-19 is suspected.
- NOT VALIDO: If within 15-20 minutes no colored line appears in the control area (C), the test is not valid. Repeat the test with a new test box.

Warnings
Read the instructions carefully.
Do not use the product if the envelope is damaged or the seal is broken.
The product must be used at room temperature (from 15°C to 30°C). If the product has been stored in a colder environment (temperature less than 15°C), leave it at a normal ambient temperature for 30 minutes before use.
Treat all samples as potentially infectious.
The collection, preservation and transport of samples conducted in an unsuitable or uninterested manner can lead to imprecise test results.
Use the pads provided in the package to ensure optimal test performance.
The correct sampling is of fundamental importance for the test. Make sure to collect enough sample material to analyze (s nasal excretions) with the swab, especially for the nasal sample withdrawal at the front.
Blow your nose several times before taking the sample.
Samples must be examined as soon as possible after the withdrawal.
Introduce sample drops to be analyzed only in the well (S).
Too many or too few drops of the extraction solution can make the test result invalid or incorrect.
Children under 14 years must be assisted by an adult.
The test must be used exclusively for qualitative detection of SARS-CoV-2 virus antigens in front nasal swab samples (front of the nose). The exact concentration of SARS-CoV-2 virus antigens cannot be determined by this test.
It is essential to carry out a correct sampling. Failure to comply with the procedure can lead to inaccurate test results. Taking, preserving and freezing and unsuitable defrosting of the sample can lead to inaccurate test results.
If the viral load of the sample is lower than the test detectability limit, the test can give a negative result.
As with all diagnostic tests, a final clinical diagnosis should not be based on the result of a single test, but should be formulated by the doctor following the evaluation of all clinical and laboratory results.
Regardless of SARS-CoV-2, a negative result does not exclude viral infection and should be confirmed by molecular diagnostics if it is suspected of COVID-19.
A positive result does not exclude co-infection with other pathogenic agents.
The quick test for the SARS-CoV-2 antigen can detect both the presence of vital and non-life material of SARS-CoV-2. The quick test performance for the SARS-CoV-2 antigen depends on the viral charge and may not be related to other diagnostic methods performed on the same sample.
Users should test the samples as quickly as possible after picking and in any case within two hours of the sample.
The sensitivity of nasal or oropharynx buffers may be lower than that of nasopharynx buffers. The method of nasopharynx buffer must be performed by healthcare professionals.
Monoclonal antibodies that have undergone slight changes in amino acids in the target epitopic region, may fail to detect or detect with less sensitivity the SARS-CoV-2 virus.
The amount of antigen in a sample can decrease with the increased duration of the disease. Samples taken after the 5th- 7th day of disease are more likely to be negative than a RT-PCR test.
The kit has been verified with the supplied tampons. Using other tampons can lead to negative fake results.
The validity of the quick test for the SARS-CoV-2 antigen was not proven for the identification/confirmation of tissue crop blocks and should not be used in this function.
The cross-reactivity of the test box has been evaluated by testing viruses and other microorganisms. The definitive concentrations of viruses and other microorganisms are documented in the study of Cross-Reactivity. The viruses and other microorganisms listed there, except for the human coronavirus of SARS, have no influence on the test results of the test box. The positive results of the test do not exclude packaging with other pathogenic agents. Positive results can occur in case of SARS-CoV-2 infection.

Conservation
Store the test at a temperature between 4 and 30°C in the original sealed envelope. Don't freeze.
Do not use the product after the expiry date.
Validity of whole packaging: 18 months.

Format
Kit of 5 pieces and 20 pieces. Contains:
- Test box for SARS-CoV-2 antigen
- Sterile leg
- Extraction test
- Extraction solution
- Instructions for use
- Door test tubes

Cod.
831 (5 pieces)
832 (20 pieces)