Description
Test for in vitro qualitative detection and simultaneous differentiation of the new coronavirus (SARS-CoV-2 antigen), flu A virus and RSV antigen in samples collected through nasal swab.
It can be used as a reference for the diagnosis of coronavirus infectious disease (COVID-19) caused by SARS-CoV-2 detected in symptomatic individuals within 7 days from when symptoms appear. It can also be used as a reference during diagnosis of diseases caused by A/B or RSV influence.
This kit is suitable for individuals over 2 years of age. People between 2 and 14 years of age cannot test themselves. The collection and analysis of the sample with this kit must be carried out by adults or parents (aged between 18-60 years).
Persons between 14 and 17 years of age can use this kit for collecting and analyzing the sample by themselves, provided that they are under the supervision of adults or parents (with age between 18-60 years), the latter must ensure that the individual using the test understands well the requirements provided by the instructions of use and follow the procedure correctly.
For people over 75 years old, it is recommended that family members or caregivers carry out the collection and analysis of the sample.
The SARS-CoV-2 antigen & A/B & RSV influence is qualitatively detected in the samples collected by nasal buffers using the colloidal gold method. After adding the sample, the SARS-CoV-2 antigen (or A/B & RSV influence) in the test sample is combined with the anti-SARS-CoV-2 antibody (or A/B & RSV influence) marked with colloidal gold to form the Ab-Ag SARS-CoV-2 colloidal gold complex (or A/B & RSV influence). Through chromatography, the Ab-Ag SARS-CoV-2 colloidal gold complex (or A/B & RSV influence) spreads along the nitrocellulose membrane. Within the test line area, the Ab-Ag SARS-CoV-2 colloidal gold complex (or A/B & RSV influence) binds to the antibody enclosed within the test line area, showing a purple red line. The antibody marked with anti-SARS-CoV-2 colloidal gold (or A/B & RSV influence) spreads into the area of the quality control line and is captured by the anti-tope goat IgG to form the red lines. At the end of the reaction, the results can be interpreted by visual control.
For self-diagnosis.

Mode of use
Sample collection
Carefully extract the sterile nasal tampon from the package.
Avoid touching the cotton tip of the tampon. Insert the nasal tampon to a depth of about 2.5 cm in the nostril. Rotate the swab against the nasal walls 5 times to ensure that the sampling took place correctly. Repeat the procedure in the other nostril, using the same nasal swab, in order to carry out a sample withdrawal sufficient from both nostrils and make sure that the sampling takes place correctly.

How to perform the test
Use a disinfectant to disinfect your hands after washing them. Clean the tabletop on which the test will run.
Before testing, carefully read the instructions and wait for the kit and samples to reach the ambient temperature (20-25 °C) before use. The test must be performed at 20-25 °C. If the kit is removed from the refrigerator, let it return to room temperature (20-25 °C) 5 minutes before testing.
Avoid the cap of the extraction test and remove the inner blue cap. The purpose of the blue cap is to prevent the output of the product during transport. Insert the extraction test into the support hole provided with the kit or use a test door to keep the test tube vertically.
Insert the sample into the extraction tube, then break the swab stick and insert the bottom of the swab into the tube. Reboot the cap and close the extraction test. Press the pad 10 times against the wall of the tube, then wait 1 minute for the reaction of the sample. Unscrew the terminal on the top of the cap.
Each cockpit on the test box requires 2 drops (about 60 mcL) of the treated sample solution. The wells marked with a "S" under the respective words COVID-19, influence A/B or RSV are the wells where to deposit the sample. You can deposit the drops on all 3 wells at the same time to detect 3 different types of antigens, or you can deposit the drops in a single well to detect only one type of antigen. In each well it is possible to deposit only 2 drops of the solution of the treated sample. Adding an excessive or insufficient amount of the treated sample solution may invalidate the test results.
The test box must be kept at room temperature for 15 minutes to observe the results, but the results detected after 20 minutes will not be valid. If reading results takes place after 20 minutes, the results may be incorrect or invalid. While waiting, do not touch or move the test box.
Adopt security measures during the test to prevent the transmission of the infection. Once the result is read out and the test, place the components used in a plastic bag, seal the bag and put it in another plastic bag to throw it away. Use a disinfection for your hands.

Interpretation of results
- Positive to COVID-19 or RSV: two red lines appear. A line appears in the area of the test line (T) and a line appears in the control line area (C). The color intensity of the test line (T) varies on the basis of the antigens present in the sample. The result is always to be considered positive.

- Positive to influence A/B: if the line A and the control line (C), the individual is positive to influence A. If line B and control line appear (C), the individual is positive to influence B. If both line A and line B appear, and the control line (C), the individual is subject to both influence A and influence B. The color intensity of the test line (A and/or B) varies on the basis of the antigens present in the sample. The result is always to be considered positive.

- Negative: only one red line appears in the control line area (C). No line appears in the test line area (T, A/B).

- Not valid: the line does not appear in the control line area (C). The result is not valid. Use a new test kit and test again. If the new test again gives invalid results, stop using the kit and contact the local distributor.

Warnings
Only for in vitro diagnostic use.
Read all instructions for use before using the kit and follow them carefully. Otherwise, wrong results can occur.
Disposable kit: cannot be reused.
Do not ingest the product.
Avoid entering the extraction solution in contact with the eyes or with the skin.
Keep out the product from the reach of children.
Do not touch the reaction area on the test box.
Do not use the kit if the packaging is damaged or not well sealed.
All samples and components of the kit are potentially infectious. Dispose of all used components and samples according to local standards regarding the disposal of infectious health waste.
Make sure an adequate amount of the extraction solution is used: an excessive or insufficient amount of solution can cause incorrect results.
The final result must be read within 15 minutes of the test. Please do not read the result after 20 minutes.
Do not mix kit components from different batches to avoid wrong results.
Negative results may occur if the amount of antigen present in the sample is lower than the test detectability limit or if the sample is taken incorrectly.
Negative results do not exclude other possible virus infections that are not COVID-19, influenza virus or RSV virus.
The sampling, transport or improper packing can cause false negative results.
This is a qualitative test. To be sure that the individual is infected, you should contact a doctor who analyzes the results of the test along with other clinical and laboratory results and data.
A negative result to COVID-19 antigen, A/B or RSV influence, does not exclude COVID-19 infection, A/B or RSV influence and does not exempt the individual from the applicable norms for the containment of the spread of the disease.

Conservation
Store at a temperature between 2-30 °C, in a dry place and protected from light.
The test box must remain in the sealed envelope until use. Once the envelope is opened, the test must be performed within an hour.
Do not use the test kit after the expiration date shown on the package.
Validity of whole packaging: 18 months.

Format
The kit contains:
- test box;
- extraction solution;
- sterile nasal swab;
- test for sample treatment;
- leaflet.

Cod. MF-71-1