Covid-19 - rapid antigen test (oral fluid)

Product Description

Covid-19 Rapid Test.

Features

JusCheck COVID-19 Rapid Antigen Test (Oral Fluid) is a 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 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.

How to use

Before testing
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 water and soap 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 plastic tube from the packaging and 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 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: Sample Preparation
  Place the tube in the plastic holder.
  Pull to open the buffer solution and pour the entire solution into the tube with the oral fluid. Replace 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 cassette on a flat surface.
  Invert the tube and dispense 2 drops of solution into the well (S) of the test device and then start the timer. Do not move the test cassette during 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 test.

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 colored line should appear in the test region (T).
  A positive result means that the person is very likely to have COVID-19. Positive samples must be confirmed. Immediately self-isolate as required by local regulations and contact your healthcare provider or district health care provider as directed by local authorities.
  The test will be verified by a confirmatory molecular (PCR) test and instructions on the next steps will be provided.
  *NOTE: 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.
• NEGATIVE: Only one colored line appears in the control region (C). No colored line appears in the test line region (T).
  It is unlikely that the person has been infected with COVID-19. However, it is possible that this test may give an incorrect result (false negative) in some people with COVID-19. This is because the test may not give a false negative result. This means that you may have contracted COVID-19 even if the test was negative.
  If you experience symptoms such as headache, migraine, fever, loss of taste and smell, contact the nearest healthcare provider according to the rules of the local authority. You can also repeat the test with a new kit.
  If you suspect you have COVID-19, 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 procedure are the most common causes. probable causes of the missing control line.
  Review the procedure and repeat the test with a new kit or contact your healthcare provider 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 provided 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 healthcare provider and carefully follow local instructions/regulations for COVID cases.
Testing 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 certain steps in the test procedure may result in incorrect results.
The results obtained with the test must be considered in addition to other clinical results from other tests and laboratory evaluations.
If the test result is negative or nonreactive 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 You are not ready to perform the test.
Shelf life with intact packaging: 24 months.

Format

The kit contains:

• Test device;
• Sample collection device (funnel, tube and tube tip);
• Buffer solution;
• Instruction leaflet;
• Biosafety bags.