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Clungene Covid-19 Antigen Rapid Test 5 Tests

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Clungene Covid-19 Antigen Rapid Test 5 Tests

Rapid Antigen Test provides COVID-19 screening results in 15 – 20 minutes.

The Clungene Covid-19 Antigen Rapid Test is a SARS-COV-2 immunoassay screening device for the qualitative detection  of a nucleocapsid protein, an antigen, which form part of the SARS-CoV-2 virus.

The main benefit of this Device is to find out whether a person carries the SARS-CoV-2 virus during onset of COVID-19. Recommended use is to test persons with COVID-19 symptoms.

Any person who has a positive rapid antigen test result should immediately have a confirmatory PCR test at a COVID-19 testing centre.

Intended use:

The Clungene COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab or nasal swab from individuals who are suspected of COVID-19 within the first seven days of symptoms.

Each Clungene COVID-19 Antigen Rapid Testing Kit includes:

  • Test Cassette, which holds the test strip where detection of the SARS-COV-2 nucleocapsid antigen take place.
  • Extraction Reagent Tube.
  • Collection swab
  • Waste bag
  • IFU/Product insert

The Clungene COVID-19 Antigen Testing Kit is listed with the TGA – ARTG Identifier 333341.

The Clungene COVID-19 Antigen Rapid Screen Test is listed as and IVD Class 3 in the Australian Register of Therapeutic Goods, ARTG.

APAC Security is registered as the sponsor of the testing kit.

Easy to use

  1. Sampling – The entire tip of the swab, app 2.5 cm, is inserted into the left nostril, where it is firmly brushed against the inside of the nostril in a circular motion 5 times or more. With the same swab, carry out the same procedure in the right nostril.
  2. Extraction – After sampling the swab is inserted into a tube containing an extraction solution, where it is left for a minute.
  3. Analysis – Three droplets of the extraction solution, now containing the sample, is added to a sample well on the test cassette. Results are read after 15 minutes.

Interpretation of results

Results are read from the window of the Test Cassette, which is marked from top to bottom with
C and T;

C is a control line, which must always be present at the time of analysis. No C-line means that the test is invalid and a new test should be performed.

T is a Test line indicating the presence of the SARS-CoV-2 virus. A line should be read as a presumptive positive test, indicating that the test person is likely to carry the COVID-19 disease. No line should be interpreted as a negative test.

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