Description
This kit is intended for in vitro self-diagnostic use for the qualitative determination of SARS-CoV-2 antigen in human specimens obtained from nasal swab.
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 onset of symptoms.
Children and minors must be supported by an adult to perform the test.

How to use
Wash and dry your hands thoroughly before testing. Read the instructions for use carefully before performing 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, rotate 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 muffled tip to the bottom of the tube at least 3 times. Before removing the swab from the tube, squeeze the tip by squeezing the flexible tube several times from the outside with your fingers. Close the tube with the special 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 to the well (S) of the reagent card.
Read the results after 15 minutes. The results read after 30 minutes are no longer valid.
After testing, seal all used components in the appropriate biowaste bag. Do not reuse.
Wash or disinfect your hands again.

Interpretation of the results:
- POSITIVE: two red bands appear in the reading window. A red or purple band appears in the control zone (C) and the other near the test zone (T), thus indicating a positive test and a suspected COVID-19 infection.

- NEGATIVE: in the reading window only one red-violet band is visible in the control zone (C), thus indicating the absence of the SARS-CoV-2 virus in the analyzed sample or that the virus concentration is below the detection limit of the kit.

- INVALID: no red-violet 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.

Warnings
This kit is for in vitro diagnostic use only. Please read the instructions carefully before performing the test.
Use only the components provided in the kit, do not substitute the kit material.
Use only undamaged components.
Follow the instructions for use strictly and do not mix components from different lots.
Never drink the buffer solution. If ingested, contact your doctor immediately.
The kit provides a qualitative result only, it is unable to quantify the concentration of the SARS-CoV-2 antigen in the sample.
The test result cannot be used as the sole confirmation of the diagnosis. Symptoms, medical history, other laboratory tests and patient information should be carefully considered prior to clinical management.
Children and minors must be supported by an adult.
The test cannot be used with non-human samples.

storage
Store at a temperature ranging from 4 ° C to 30 ° C.
Validity for intact packaging: 12 months.

Format
The kit contains:
- SARS-CoV-2 antigen test card
- extraction tube with buffer
- disposable sterile swab
- biohazard waste bag
- Instructions for Use

Bibliography
1. Wu C, Liu Y, Yang Y, Zhang P, Zhong W, Wang Y, et al. (February 2020). "Analysis of therapeutic targets for SARS-CoV-2 and discovery of potential drugs by computational methods". Acta Pharmaceutica Sinica B. doi: 10.1016.

Cod.HGCG134S0120