Professional saliva test for Covid 19 - 20 tests

Description
Single-use test intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid.
The test is for professional use only. It is a qualitative membrane-based immunoassay for the determination of SARS-CoV-2 antigens in human oral fluid specimens.
The test provides only a preliminary result, the final confirmation must be based on clinical diagnostic results.

Instructions for use
Before taking the test
Do not put anything in your mouth, including food, drinks, chewing gum, or tobacco products 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 keep your distance from others.
Gently spit the oral fluid into the funnel. Oral fluid (without bubbles) should reach the height indicated by the reference line.
If insufficient fluid is collected, repeat the sample collection steps.
Place the used funnel in the bio-safety 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: Running the test
Remove the test device from the sealed pouch and use within one hour. The best results are obtained if the test is performed immediately after opening the foil pouch.
Place the test cassette on a flat surface.
Turn the tube upside down 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 the results after 15 minutes. Do not interpret results after 20 minutes.
After completing the test, place all components of the test kit in the bio-safety bag and dispose of it according to local regulations.
Do not reuse any of the used kit components.
Wash your hands thoroughly after disposing of the test.

- POSITIVE: two colored lines appear. A 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 be infected with COVID-19.

- 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 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 your test result is negative.
In case of 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 suspected, repeat the test after 1-2 days, as coronavirus cannot be determined 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 of control line failure. Review the procedure and repeat the test with a new kit or contact your doctor or a COVID-19 diagnosis center.

Warnings
Read the information leaflet carefully before carrying out the test.
The test is disposable, do not reuse. Do not use after the expiry date.
Do not eat, drink or smoke in the area where you handle specimens or kits.
Do not drink the buffer solution in the kit. Handle the buffer solution with care and prevent it from coming into contact with skin and eyes. In case of contact, rinse immediately with plenty of running water.
Do not use the test if the packaging is damaged.
Wash your hands thoroughly before and after handling.
If the preliminary result is positive, inform your doctor of the result and carefully follow the local instructions/regulations for COVID cases.
Tests performed on children and teenagers must be carried out in the presence of adults.
The used test must be disposed of according to local regulations.
Failure to follow some steps of the test procedure may lead to 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 retest with a new testing device 1-2 days later or go to 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.

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

Bibliography
1. BACKINGER, CL and KINGSLEY, PA , Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, Rockville, MD, US Food and Drug Administration, Center for Devices and Radiological Health, HHS Pub. FDA 93-4258