ALLTEST
COVID-19 Antigen
Rapid Test (Oral Fluid)
Description
Single-use test intended to detect the novel 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 samples by symptomatic individuals suspected of being infected with the COVID-19 virus.
It is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 antigens in human oral fluid samples.
The test provides only a preliminary result; final confirmation must be based on clinical diagnostic results.
Directions for use
Before performing the test
Do not put anything in your mouth, including food, drinks, chewing gum or tobacco products, for at least 10 minutes before performing the test.
Wash your hands with soap and water for at least 20 seconds before the test. If soap and water are not available, use a hand sanitiser with at least 60% alcohol.
Step 1: Sample collection
Remove the funnel and the plastic tube from the pack and fit 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 oral fluid into the funnel. The oral fluid (without bubbles) should reach the height indicated by the reference line.
If the fluid collected is not sufficient, repeat the sample collection steps.
Place the used funnel in the biosafety bag.
Step 2: Sample preparation
Pull to open the buffer solution and pour all of it into the tube containing the oral fluid. Fit the cap onto the tube. Gently squeeze the tube 10-15 times to mix well.
Step 3: Performing the test
Remove the test device from the sealed pouch and use it within one hour. 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 add 2 drops of solution to the well (S) of the test device, 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, put all components of the test kit in 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 local instructions/regulations for COVID cases.
- POSITIVE: two coloured lines appear. One coloured line should appear in the control region (C) and another coloured line should appear in the test region (T). The colour intensity in the test line region (T) varies depending on the amount of antigen present in the sample. Therefore, any shade of colour in the test region (T) should be considered a positive result. A positive result means it is very likely that the person is infected with COVID-19.
Positive samples must be confirmed. Self-isolate immediately as required by local regulations and contact your doctor or local health service according to the instructions of the local authorities. The result will be checked with a confirmatory molecular test (PCR) and instructions on the next steps will be provided.
- NEGATIVE: only one coloured line appears in the control region (C). No coloured line appears in the test line region (T). It is unlikely that the person is infected with COVID-19. However, the test may give an incorrect result (false negative) in some people with COVID-19. This means you could have COVID-19 even if the test is negative.
If you have symptoms such as headache, migraine, fever, loss of taste and smell, contact the nearest healthcare facility according to the rules of the local authority.
You can repeat the test with a new kit. If in doubt, repeat the test after 1-2 days, as the coronavirus cannot be detected 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 reasons for control line failure. Review the procedure and repeat the test with a new kit, or contact your doctor or a COVID-19 testing centre.
Warnings
Read the package leaflet carefully before performing the test.
The test is intended for in vitro self-testing only.
The test is single-use; do not reuse. Do not use after the expiry date.
Do not eat, drink or smoke in the area where samples or kits are handled.
Do not drink the buffer solution in the kit. Handle the buffer solution with care and avoid 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 local instructions/regulations for COVID cases.
Tests on children and young people must be carried out in the presence of adults.
The used test must be disposed of according to local regulations.
Failure to follow certain steps of the test procedure may lead to incorrect results.
The results obtained with the test should be considered in addition to other clinical findings from other tests and laboratory evaluations.
If the test result is negative or non-reactive but clinical symptoms persist, this may be because the virus is not detectable in the early stage of infection. It is advisable to repeat the test with a new test device 1-2 days later or to 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 a temperature between 2 °C and 30 °C. Do not freeze.
Do not open the pack until you are ready to perform the test.
Shelf life in unopened packaging: 24 months.
Size
The kit contains:
- Test device;
- Sample collection device (funnel, tube and tube tip);
- Buffer solution;
- Package leaflet;
- Biosafety bag.
Code ICOV-802H
