Description
Single use test intended to detect the novel coronavirus SARS-CoV-2 which causes COVID-19 in human oral fluid.
The test is designed for home use with self-collection of oral fluid samples. The test is intended for use in symptomatic individuals who meet the case definition for COVID-19 as well as asymptomatic individuals, limited to contacts of confirmed or probable cases of COVID-19 and healthcare workers at risk.
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.

How to use
Before testing
Do not put anything into your mouth, including food, drink, 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 the plastic tube from the package, insert the funnel on 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-safety bag.

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

Step 3: Running the test
Remove test device from 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 results after 15 minutes. Do not interpret results after 20 minutes.
After completing the test, place all components of the test kit into the biosafety 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.

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

- 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 color tinge in the test region (T) should be interpreted as a positive result. A positive result means that it is very likely that the person has COVID-19.
Positive samples must be confirmed. Self-isolate immediately, as required by local regulations, and contact your treating physician or district health care as instructed by local authorities. The test yes