ALLTEST COVID-19 ANTIGEN RAPID SELFTEST

Rapid test for COVID-19 antigen (oral fluid) for self-test

The COVID-19 Antigen Rapid Test Cassette (Oral Fluid) is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid. This test is intended for home use with self-collected oral fluid samples from symptomatic individuals suspected of being infected with COVID-19. The test provides only preliminary results, final confirmation should be based on clinical diagnostic results. The COVID-19 Antigen Rapid Test Cassette (Oral Fluid) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human oral fluid samples.
The test device contains antibodies to SARS-CoV-2.

How to use

Remove the funnel and the plastic tube, mount the funnel on the tube.
Cough deeply 3-5 times. Wear a face mask or cover your mouth and nose with a tissue when coughing and keep your distance from other people.
Gently spit the oral fluid into the funnel. Oral fluid (without bubbles) should just reach the height of the scale line. If there is not enough oral fluid collected, repeat the sample collection steps. Place the used funnel in the biological safety bag.
Tear off to open the swab and add the entire swab to the oral fluid tube. Mount the tip of the tube on the tube. Gently squeeze the tube 10-15 times to mix well.
Remove the test device from the sealed foil 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 and level surface. Invert the tube and add 2 drops of solution to the sample well (S) of the test device, then start the timer. Do not move the test cassette during test development.
Read the result after 15 minutes. Do not interpret the result after 20 minutes. Once the test is complete, place all test kit components in a biological safety bag and dispose of according to local regulations. Do not reuse used kit components. Wash your hands thoroughly after disposing of the test.
- Interpretation of the results:
POSITIVE: two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).
NEGATIVE: A colored line appears in the control region (C). No apparent colored lines appear in the test line region (T).
INVALID: The control line is not displayed. Insufficient sample volume or incorrect procedure are the most likely reasons for the absence of the control line. Review the procedure and retest with a new test or contact your doctor or a COVID-19 testing center.
Note: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 antigen present in the sample. Hence any shade of color in the test region (T) should be considered positive.

Warnings

Before testing, do not put anything in your mouth, including food, drinks, chewing gum, or tobacco products for at least 10 minutes prior to harvest. Wash your hands with soap and water for at least 20 seconds before and after the test. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
Failure to follow the test steps can give inaccurate results.
The COVID-19 Antigen Rapid Test Cassette (Oral Fluid) is for in vitro diagnostic use only.
The results obtained with the test should be considered in conjunction with other clinical results from other laboratory tests and evaluations.
If the test result is negative or non-reactive and clinical symptoms persist, it is recommended to retest with a new test 1-2 days later or to go to the hospital to rule out an infection.
Positive COVID-19 results may be due to infection with non-SARS-CoV-2 coronavirus strains or other interfering factors.
Read the entire package insert before performing the test.
For in vitro self-test for diagnostic use only.
The test is for one time only, do not reuse the test. 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 swab in the kit. Handle the swab carefully and prevent it from coming into contact with the skin or eyes, in case of contact, rinse immediately with plenty of running water.
Do not use the test if the pouch is damaged.
Wash hands thoroughly after handling.
If the result is preliminarily positive, share the test result with your doctor and carefully follow your local COVID guidelines / requirements.
The child and youth test should be used in the presence of an adult.
The used test must be disposed of according to local regulations.
Do not open the pouch until ready to use. Do not freeze.

storage

Store the test at 2 ° C -30 ° C.
Validity for intact packaging: 16 months.

Format

1 kit consisting of:
- test device;
- collection device (funnel, tube and tube tip);
- buffer;
- Biological safety fellowship;
- package leaflet.

Cod. ICOV-802H