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 samples.
The test provides only a preliminary result, the final confirmation must be based on clinical diagnostic results.

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

Step 1: Sample Collection
Remove the funnel and plastic tube from the packaging, 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 bystanders.
Gently spit the oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line.
If there is not enough fluid collected, repeat the steps for sample collection.
Insert the used funnel into the bio-security 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 compress the tube 10-15 times to mix well.

Step 3: Test Execution
Remove the test device from the sealed pouch and use it 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 the test is running.

Step 4:
Read the results after 15 minutes. Do not interpret the 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 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 zone (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) must be interpreted as a positive result. A positive result means that it is very likely that the person is 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 the test gave a negative result.
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 the coronavirus cannot be determined at all stages of infection.
Even with a negative result, the rules of distancing and hygiene 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 retest with a new kit or contact your healthcare provider or a center for COVID-19 diagnosis.

Warnings
Read the package leaflet carefully before taking the test.
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 you are handling specimens or kits.
Do not drink the buffer solution in the kit. Handle the buffer solution with care and avoid it 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 healthcare provider of the result and carefully follow local COVID case instructions/regulations.
Tests performed on children and young people must be carried out in the presence of adults.
The used test should be disposed of according to local regulations.
Failure to follow certain steps of the test procedure may result in incorrect results.
The results obtained with the test should be considered in addition to other clinical results of other laboratory tests and evaluations.
If the test result is negative or unresponsive but clinical symptoms persist, it is because the virus may not be detectable at the early stage of infection. It is recommended to retest with a new test device 1-2 days later or to 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.

Preservation
Store at temperatures between 2 °C and 30 °C. Do not freeze.
Do not open the package until you are ready to test.
Shelf life in unopened packaging: 24 months.

Bibliography
1. BACKINGER, C.L. and KINGSLEY, P.A., Recommendations for Developing User Instruction Manuals for Medical Devices Used in Home Health Care, Rockville, MD, U.S. Food and Drug Administration, Center for Devices and Radiological Health, HHS Pub. FDA 93-4258