***Available For Immediate Dispatch***

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

Intended Use:

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

Kit Includes:

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

Warnings and Precautions:

• For in vitro diagnostic use only
• Do not use this test as the only guide to managing your illness. Please contact your State or Territory Coronavirus testing services to get a laboratory PCR test 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.
• Expiration Date: December 2023
• Only use the test once and only with the provided parts.
• Do not undertake testing in direct sunlight.
• Avoid contact with Extraction reagents. 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 of all parts of the used test kit into the waste bag, then discard the waste bag in the general waste.

Resources:

• For information on COVID-19 in your state or territory, click here
• To find out more about COVID-19, visit the Commonwealth Department of Health website here.
• Click here for a fact sheet explaining how to use COVID-19 home test kits and what to do when you get a result.
• Download the instructions for using this test kit here.

More Information:

• Box contains five individual tests.
• Usage instructions are included with the packaging.

More Questions:

Still unsure if this product is right for your intended use? Get in contact with one of our Clinical Professionals via the contact us page.