Rapid Covid-19 Self-Diagnostic Saliva Antigen Test Qualitative Determination of Sars-CoV-2 Antigens in Saliva Samples by Immunochromatography Sofarmapiu' Sofarmapiu'

Description
Single-use test intended to detect the novel SARS-CoV-2 coronavirus that causes COVID-19 in human oral fluid.
The test is designed for home use with self-collection of oral fluid samples from symptomatic individuals suspected of having been infected with the COVID-19 virus.
It is a qualitative membrane-based immunoassay for the determination of SARS-CoV-2 antigens in human oral fluid samples.
The test only provides a preliminary result; final confirmation must be based on clinical diagnostic results.

How to use
Before performing the test
Do not put anything in your mouth, including food, drinks, chewing gum or tobacco products for at least 10 minutes before performing the test.
Wash your hands with soap and water for at least 20 seconds before the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.

Step 1: Sample Collection
Remove the funnel and plastic tube from the package, insert the funnel onto the tube.
Cough deeply 3-5 times. Wear a face mask or cover your mouth and nose with a cloth while coughing and maintain distance from others.
Gently spit oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line.
If the collected fluid is insufficient, repeat the sample collection steps.
Place the used funnel in the biohazard bag.

Step 2: Sample Preparation
Pull to open the buffer solution and pour all the solution into the tube with the oral fluid. Insert the cap onto the tube. Gently squeeze the tube 10-15 times to mix well.

Step 3: Performing the test
Remove the test device from the sealed pouch and use it within one hour. Best results are obtained if the test is performed immediately after opening the foil pouch.
Place the test cassette on a flat surface.
Invert the tube and dispense 2 drops of solution into the well (S) of the test device and then start the timer.
Do not move the test cassette while performing the test.

Step 4:
Read the results after 15 minutes. Do not interpret the results after 20 minutes.
After completing the test, place all test kit components in the biohazard bag and dispose of them according to local regulations.
Do not reuse any of the used kit components.
Wash your hands thoroughly after disposing of the test.

Reading the results
Inform your doctor of the results and carefully follow local instructions/regulations for COVID cases.

- POSITIVE: two colored lines appear. One colored line should appear in the control region (C) and another colored line should appear in the test region (T). The color intensity in the test line region (T) will vary depending on the number of antigens present in the sample. Therefore, any shade of color in the test region (T) should be interpreted as a positive result. A positive result means that the person is very likely to be infected with COVID-19.
Positive samples must be confirmed. Immediately self-isolate, as prescribed by local regulations, and contact your doctor or healthcare district according to local authority instructions. The test will be verified by a confirmatory molecular test (PCR) and instructions on the next steps will be provided.

- NEGATIVE: only one colored line appears in the control region (C). No colored line appears in the test line region (T). It is unlikely that the person is infected with COVID-19. However, it is possible for the test to give an incorrect result (false negative) in some people with COVID-19. This means that you may have contracted COVID-19 even if the test result was negative.
In case of symptoms such as headache, migraine, fever, loss of taste and smell, contact the nearest healthcare facility, according to local authority rules.
You can repeat the test with a new kit. If in doubt, repeat the test after 1-2 days, as the coronavirus cannot be determined in all stages of infection.
Even with a negative result, social distancing and hygiene rules must continue to be observed.

- INVALID: the control line does not appear. Insufficient sample volume or incorrect procedure are the most likely causes of the control line not appearing. Review the procedure and repeat the test with a new kit or contact your doctor or a COVID-19 diagnostic center.

Warnings
Read the leaflet carefully before performing the test.
The test is for in vitro self-diagnosis only.
The test is for single use, do not reuse. Do not use after the expiration date.
Do not eat, drink or smoke in the area where samples or kits are handled.
Do not drink the buffer solution in the kit. Handle the buffer solution carefully and avoid contact with skin and eyes. In case of contact, rinse immediately with plenty of running water.
Do not use the test if the package is damaged.
Wash hands thoroughly before and after handling.
If the preliminary result is positive, inform your doctor of the result and carefully follow local instructions/regulations for COVID cases.
Tests performed on children and adolescents must be carried out in the presence of adults.
The used test must be disposed of according to local regulations.
Failure to observe some steps of the test procedure may generate incorrect results.
The results obtained with the test must be considered in addition to other clinical results from other tests and laboratory evaluations.
If the test result is negative or non-reactive but clinical symptoms persist, it is because the virus may not be detectable in the early stage of infection. It is recommended to repeat the test with a new test device 1-2 days later or go to the hospital to rule out infection.
Positive COVID-19 results may be due to infection by non-SARS-CoV-2 virus strains or other interfering factors.

Storage
Store at temperatures between 2 °C and 30 °C. Do not freeze.
Do not open the package until you are ready to perform the test.
Validity with intact packaging: 24 months.

Format
The kit contains:
- Test device;
- Sample collection device (funnel, tube and tube tip);
- Buffer solution;
- Leaflet;
- Biohazard bag.

Cod. ICOV-802H