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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 two separate test strips, where detection of the SARS-COV-2 and Influenza A+B 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.

Interpretation of results

  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 both sample wells on the test cassette. Results are read after 15 minutes.

Easy to use

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.

Clinical Performance

The clinical performance of CLUNGENE COVID-19 Antigen Rapid Test for self-testing was evaluated in a prospective study in Greece between June 2021 and July 2021. A total of 578 laypersons (of which, 122 within 7 days post symptom onset) were sequentially enrolled. No additional training or instructions were provided. Self-sampling with nasal swabs and self-testing were conducted by participants using the COVID-19 Antigen Rapid Test. For comparison, to each of the participants, an RT-PCR testing was performed by professional sampling with nasopharyngeal swab. The COVID-19 Antigen Rapid Test showed a sensitivity of 95.1% (95% confidence interval: 89.7%-97.7%, N=122) and a specificity of 100% (95% confidence interval: 99.2%-100%, N=456) compared to RT-PCR.

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Shelf life and Storage conditions

The Clungene Covid-19 Antigen Rapid Self Test offers two years shelf life from date of manufacturing.
Storage temperature 4ºC – 30ºC.

Warnings and Precautions

  1. For in vitro diagnostic use only.
  2. Do not use this test as the only guide to manage your illness. Please contact your State or Territory
  3. Coronavirus testing services to get a laboratory PCR test if your symptoms are persisting or worsening, or if you are concerned at any time.
  4. The test is less reliable in the later phase of infection and in asymptomatic individuals.
  5. Negative results may occur if testing is not performed within the first 7 days of symptom onset.
  6. If the test is to be used on a person under 15 years of age, the test must be undertaken by an adult.
  7. Keep out of reach of children to reduce the risk of accidentally drinking the extraction reagent or swallowing small parts.
  8. Do not use this product after the expiration date.
  9. Only use the test once and only with the provided parts.
  10. Do not undertake testing in direct sunlight.
  11. Avoid contact with Extraction Reagent. If the extraction reagent is accidentally exposed to a person’s skin or eye, rinse with plenty of running water immediately. If irritation persists, seek medical assistance.
  12. This test involves taking a sample from deep inside your nose. When doing the test, pay particular attention to the instructions on how to swab your nose. Incorrect swabbing may lead to an inaccurate test result.
  13. The test cassette should remain in the sealed pouch until use.
  14. Wash hands thoroughly before and after testing.
  15. Dispose all parts of the used test kit into the waste bag, then discard the waste bag in the general waste.