Single-use test intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in human oral fluid.
Indications
The test is intended for home use, with self-collection of oral fluid samples from symptomatic individuals suspected of being infected with the COVID-19 virus.
The test provides only a preliminary result; final confirmation must be based on clinical diagnostic results.
Directions for use and Dosage
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 testing. If soap and water are not available, use a hand sanitizer with at least 60% alcohol.
- Step 1 - Specimen Collection: Remove the funnel and plastic tube from the packaging and insert the funnel into the tube.
Cough deeply 3-5 times.
Wear a face mask or cover your mouth and nose with a cloth while coughing and maintain 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 the fluid collected is not sufficient, repeat the sample collection steps.
Insert the used funnel into the biosafety bag. - Step 2 - Specimen Preparation: Pull open the buffer solution and pour all of the solution into the tube with the oral fluid. Place the cap on 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.
Invert the tube and add 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 the results after 20 minutes.
After completing the test, place all test kit components in the biosafety bag and dispose of it according to local regulations.
Do not reuse any used kit components.
Wash your hands thoroughly after disposing of the tests.
Reading the Results: Inform your healthcare provider of the results and carefully follow local instructions/regulations for COVID cases.
Positive: Two colored lines appear. One colored line should appear in the control region (C) and another should appear in the test region (T).
The intensity of the color in the test line region (T) varies depending on the number of SARS-CoV-2 antigens 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 infected with COVID-19.
Positive samples must be confirmed.
Immediately self-isolate as required by local regulations.
The test will be verified by a confirmatory molecular test (PCR) and instructions on the next steps will be provided.
Negative: Only one colored line appears in the control line region (C).
No colored line appears in the test line region (T).
The person is unlikely to have COVID-19.
However, this test may give an incorrect result (a false negative) in some people with COVID-19.
This means that you may have COVID-19 even if the test was negative.
If you experience symptoms such as headache, migraine, fever, loss of taste or smell, contact your nearest health authority. nearest healthcare provider according to the rules of the local authority.
Additionally, you can repeat the test with a new kit.
If you suspect the virus, repeat the test after 1-2 days, as the coronavirus cannot be detected at all stages of infection.
Even with a negative result, social distancing and hygiene rules must continue to be observed.
Invalid: The control line does not appear.
Insufficient sample volume or incorrect testing procedure are the most likely causes of the missing control line.
Review the procedure and repeat the test with a new kit or contact your doctor or a COVID-19 testing center.
Warnings
Read the package insert carefully before performing the test.
The test is intended for in vitro self-diagnosis only.
The test is for single use only; do not reuse. Do not use after the expiration 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 package is damaged.
Wash your hands thoroughly before and after handling.
If the preliminary result is positive, inform your healthcare provider and carefully follow local instructions/regulations for COVID cases.
Tests performed on children and adolescents must be performed in the presence of adults.
The used test must be disposed of according to local regulations.
Failure to follow some steps of the testing procedure may result in serious injury. generate incorrect results.
The results obtained with the test must be considered in addition to other clinical test results and laboratory evaluations.
If the test result is negative or non-reactive but clinical symptoms persist, it is because the virus may not be detectable in the early stages of infection.
It is recommended to repeat the test with a new test 1-2 days later or 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.
Storage
Store the test at temperatures between 2-30°C.
Do not freeze.
Do not open the package until the test is complete. You are not ready to perform the test.
Shelf life with intact packaging: 24 months.
Format
The kit contains:
1 test device;
1 sample collection device;
1 buffer solution;
1 information leaflet;
1 biosafety bag.
Product Code:FRCM162203
Richiedi info sul prodotto
