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

Instructions for 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 testing.
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 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 baseline. If insufficient fluid is collected, repeat the sample collection steps outlined above.
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.

Reading the results
Inform your doctor of the results and carefully follow 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 color intensity in the test line region (T) varies depending on the number of SARS-CoV- antigens 2 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. Positive samples must be confirmed. Immediately self-isolate as required by local regulations and contact your doctor or health care district as instructed by local authorities. The test will be verified by a confirmatory molecular test (PCR) and instructions on the following steps will be provided.

NEGATIVE: only one colored line appears