This kit is intended for in vitro self-diagnostic use for the qualitative determination of SARS-CoV-2 antigen in human nasal swab specimens.
The test can be used for rapid detection of SARS-CoV-2 antigen from individuals suspected of being infected with COVID-19 within the first 7 days of symptom onset.
Children and minors must be supported by an adult to carry out the test.
Wash and dry your hands thoroughly before testing. Read the instructions for use carefully before carrying out the test.
Remove the swab from the package trying not to touch the padded tip with your hands. Gently insert the swab 1.5 cm into the nostril until resistance is felt. With moderate pressure, roll the swab 4-6 times in the nostril for at least 15 seconds. Repeat the procedure with the same swab in the other nostril as well.
After sampling, remove the purple cap from the tube and immerse the swab in it. Keep the swab immersed in the buffer solution for at least 15 seconds, rotating it several times and pressing the cushioned tip towards the bottom of the tube at least 3 times. Before removing the swab from the tube, squeeze the tip by squeezing the flexible tube from the outside several times with your fingers. Close the tube with the appropriate purple cap.
Open the package and place the test card on a flat surface. Remove the transparent cap and add 4 drops of the compound into the well (S) of the test card.
Read results after 15 minutes. Results read after 30 minutes are no longer valid.
After performing the test, seal all used components in the appropriate biological waste bag. Do not reuse.
Wash or disinfect your hands again.
- POSITIVE: two red bands appear in the reading window. One red or purple band appears in the control region (C) and the other near the test region (T), thus indicating a positive test and suspected COVID-19 infection.
- NEGATIVE: only one red-purple band is visible in the control region (C) in the reading window, thus indicating the absence of SARS-CoV-2 virus in the analyzed sample or that the virus concentration is below the limit of detection of the kit.
- INVALID: no red-purple lines appear in the reading window. The test is therefore invalid. It is recommended to review the procedure and repeat the test with a new kit.
This kit is for in vitro diagnostic use only. Please read the instructions carefully before testing.
Use only the components supplied in the kit, do not substitute the material in the kit.
Only use undamaged components.
Strictly follow the instructions for use and do not mix components from different lots.
Never drink the buffer solution. If swallowed, contact your doctor immediately.
The kit provides only a qualitative result, it is not able to quantify the concentration of the SARS-CoV-2 antigen in the sample.
The test result cannot be used as the sole element in confirming the diagnosis. Symptoms, medical history, other laboratory tests and patient information should be carefully considered before clinical management.
Children and minors must be supported by an adult.
The test cannot be used with non-human samples.
Store at a temperature ranging from 4°C to 30°C.
Validity with intact packaging: 12 months.
The kit contains:
- SARS-CoV-2 antigen test card
- extraction tube with buffer
- disposable sterile swab
- biohazard waste bag
- Instructions for Use
FOR SELF-TEST USE ONLY, NOT ELIGIBLE FOR GREENPASS ISSUANCE.