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

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

How to use
Before taking the test
Do not put anything in your mouth, including food, drinks, chewing gum, or tobacco products, for at least 10 minutes before taking the test.
Wash your hands with soap and water for at least 20 seconds before testing. 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 bystanders.
Gently spit the oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line.
If the fluid collected is not sufficient, repeat the steps for sample collection.
Insert the used funnel into the biosafety bag.

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

Step 3: Running 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 pour 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 results after 15 minutes. Do not interpret results after 20 minutes.
After completing the test, place all components of the test kit into the bio-safety bag and dispose of it according to local regulations.
Do not reuse any used kit components.
Wash your hands thoroughly after disposing of the test.

Reading the results
Please inform your healthcare provider 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 intensity of the color in the test line region (T) varies depending on the number of antigens present in the sample. Therefore, the presence of 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 have COVID-19.
Positive samples must be confirmed. Immediately self-isolate as per local regulations and contact your GP or district health care provider as instructed by local authorities. The test will be verified by a confirmatory molecular (PCR) test and instructions on the next steps will be provided.

- NEGATIVE: Only one colored line appears in the control region (C). No colored lines appear in the test line region (T). It is unlikely that the person has COVID-19. However, it is possible that the test may give an incorrect result (false negative) in some people with COVID-19. This means that you may have COVID-19 even if the test was negative.
If you experience symptoms such as headache, migraine, fever, loss of taste and smell, contact the nearest health care point, according to the rules of the local authority.
You can repeat the test with a new kit. If you suspect, repeat the test after 1-2 days, as coronavirus cannot be detected at all stages of infection.
Even with a negative result, 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 for the control line not appearing. Review the procedure and repeat the test with a new kit or contact your healthcare provider or a COVID-19 testing center.

Warnings
Read the package leaflet carefully before performing the test.
The test is intended for in vitro self-diagnosis only.
The test is for single use only, do not reuse. Do not use after the expiration date.
Do not eat, drink, or smoke in the area where specimens or kits are handled.
Do not drink the buffer solution in the kit. Handle the buffer solution with care 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 follow certain steps in the test procedure may result in incorrect results.
The results obtained with the test should 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 with non-SARS-CoV-2 virus strains or other interfering factors.

Conservation
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:
- Testing device;
- Sample collection device (funnel, tube and tube tip);
- Buffer solution;
- Package leaflet;
- Bio-safety bag.

Code ICOV-802H