Product Information
Intended Use
The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swabs from individuals suspected of being infected with COVID-19 within the first 7 days of symptom onset. This test is intended for self-use by persons aged 15 years or above and also for an adult testing another person under 15 years of age. Individuals over 65 years of age should consider to seek assistance in performing the test.
The test is an aid for diagnosis of COVID-19 and only provides a presumptive test result for the SARS-CoV-2 virus. It is intended to be used in the home or similar environment by a lay person.
A negative result does not mean a person does not have COVID-19. If you have positive result and/or have symptoms, you should follow the guidance from your local State or Territory Health Department for guidance on confirmation testing, and if unwell seek medical assistance.
Clungene COVID-19 Antigen Rapid Testing Kit Contents
| Components | 1 Pack | 2 Pack | 5 Pack | 20 Pack |
|---|---|---|---|---|
| 1. Test Cassette | 1x | 2x | 5x | 20x |
| 2. Extraction Reagent Tube | 1x | 2x | 5x | 20x |
| 3. Swab | 1x | 2x | 5x | 20x |
| 4. Waste Bag | 1x | 2x | 5x | 20x |
| 5. Instructions for Use | 1x | 1x | 1x | 4x |
| 6. Work Station | / | / | / | 1x |
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. If the C-line does not appear, you need to retest with a new test cassette and contact the sponsor.
T is a Test line indicating the presence of the SARS-CoV-2 virus. A positive test result indicates that you are likely to carry the COVID-19 disease, and should follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if necessary, and if unwell seek medical assistance. If no T-line appears, the test should be interpreted as negative.
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.
Shelf Life & Storage Conditions
The LOT and the expiration date are printed on the foil packaging and box of the Clungene COVID-19 Antigen Rapid Self Test.
Store as packaged in the sealed pouch between 4ºC – 30ºC.
Warnings and Precautions
- For in vitro diagnostic use only.
- Do not use this test as the only guide to manage your illness. Please follow the guidance from your local State or Territory Health Department for guidance on confirmation testing if your symptoms are persisting or worsening, or if you are concerned at any time.
- The test is less reliable in the later phase of infection and in asymptomatic individuals.
- Negative results may occur if testing is not performed within the first 7 days of symptom onset.
- If the test is to be used on a person under 15 years of age, the test must be undertaken by an adult.
- Keep out of reach of children to reduce the risk of accidentally drinking the extraction reagent or swallowing small parts.
- Do not use this product after the expiration date.
- Only use the test once and only with the provided parts.
- Do not undertake testing in direct sunlight.
- 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.
- 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.
- The test cassette should remain in the sealed pouch until use.
- Wash hands thoroughly before and after testing.
- Dispose all parts of the used test kit into the waste bag, then discard the waste bag in the general waste.
- The test cannot differentiate SARS-CoV from SARS-CoV-2.
The Clungene COVID-19 Antigen Rapid Test is listed in the ARTG
The Clungene COVID-19 Antigen Rapid Test is listed as a Class 3 IVD in the Australian Register of Therapeutic Goods (ARTG).
Resources
For state and territory COVID information visit the relevant local state and territory health departments.
For other relevant information about COVID-19 visit the Commonwealth Department of Health website.
Download the Consumer Fact Sheet. This fact sheet explains what COVID-19 home use tests are (also known as COVID-19 rapid antigen self-tests), how they can be used at home and what to do when you get a result.