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SARS-CoV-2 antigen rapid test (from oral fluid)

A test for in vitro qualitative detection of SARS-CoV-2 antigens from oral fluid (saliva). Intended for self-testing. Results are intended for clinical use but are not used as a primary method for diagnosing SARS-CoV-2 viral infection.

Technical advantages of the test:

  1. Results in 20 minutes
  2. 99% specificity
  3. Special saliva collection tools for user convenience
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A quick guide to performing this test:

  • The test will take 30 minutes to complete.
  • The location of testing is chosen according to the convenience of the user.
  • You will need to wash your hands (or use a sanitising fluid) before taking the test.
  • DO NOT smoke, eat, drink or chew gum 30 minutes before saliva collection.
  • You MUST rinse your mouth with tap water 30 minutes before saliva collection.
Procedure:
  1. Prepare a test tube with a saliva collection cap (see back of the test pack for instructions)
  2. Allow the saliva to accumulate while the sample is taken. You can do this by placing the tip of your tongue against your front teeth with your jaw closed. It is sufficient to fill the tube with saliva at 300 microlitres (µl) limit on the tube.
  3. Once the sample has been collected, place it on a paper holder (see top corner of the package) and remove the saliva collection cap.
  4. Add the extraction reagent to the tube containing the saliva and use it completely.
  5. To mix the sample, replace the dropper lid and squeeze the sides of the tube several times (without applying force for about 25-30 seconds). Try not to shake the tube to avoid spilling its contents!
  6. Use the SARS-CoV-2 antigen rapid test cassette in the foil bag to test the sample. Hold the test cassette on a flat surface and apply two drops of the sample using a test tube with a dropper cap.
  7. Read the result after 20 minutes.
  • POSITIVE: A coloured line appears in areas (C) and (T).
  • NEGATIVE: A coloured line appears in area (C).
  • INVALID: no colour line (C) or no other colour line appears in the area.

All used components of the kit are packaged in a biohazardous waste bag and handled according to local requirements.

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