Clungene – COVID 19 Rapid Antigen Test – Nasal Swab (For Self-testing)
- Available in Boxes of 5 Tests and 10 Boxes of 5 Tests (50 Test Bulk Discount)
- Nasal Swab
- DIY Rapid Antigen Self Test (Clungene)
- TGA Approved
- Very High Clinical Sensitivity
- Evidence of Performance Against Alpha, Beta, Gamma, Delta and Omicron Variants
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 screening test result for the SARS-CoV-2 virus. It is intended to be used in the home or similar environment by a lay person. Confirmation of positive results is required by contacting your State or Territory Coronavirus testing services to get a laboratory PCR test. A negative result does not mean a person does not have COVID-19. If you have symptoms, you should have a laboratory PCR test and follow medical advice.
Use this test:
✓ If you have COVID-like symptoms including headache, fever, a cough, sore throat, loss of sense of
smell or taste, shortness of breath, etc.
✓ If you are concerned that you have been exposed to COVID-19.
Do not use this test:
X If you are prone to nosebleeds.
How does the CLUNGENE COVID-19 Antigen Rapid Test work?
The CLUNGENE COVID-19 Antigen Rapid Test is a type of test called an antigen test. When you have COVID-19, the SARS-CoV-2 virus (the virus that causes COVID-19) can be present in your nasal secretions. The CLUNGENE COVID-19 Antigen Rapid Test can detect small parts of SARS-CoV-2 virus in your nasal secretions. These small parts of the SARS-CoV-2 virus are known as proteins or antigens.
Will this test hurt?
No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a doctor.
What are the potential benefits and risks of this test?
Potential risks include:
– Possible discomfort during sample collection.
– Possible incorrect test results (see Limitations section).
Potential benefits include:
– The results, along with other information, can help your doctor make informed recommendations about your treatment/care.
– The results of this test may help limit the spread of COVID-19 to your family and others in your community.
What is the difference between a COVID-19 antigen, molecular, and antibody test?
There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus, but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection. Antibody tests are not suitable to diagnose an active COVID-19 infection.
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.
Limit of Detection (Analytical Sensitivity)
The COVID-19 Antigen Rapid Test can detect SARS-CoV-2 virus as low as 570 TCID50/mL.