TGA Approved, 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.
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.
▪ Listed with Australian Register of Therapeutic Goods (ARTG)
▪ For Self-testing
▪ Very High Sensitivity
▪ Get Results at 15-20 Minutes
▪ Pack of 5 (1 Pack = 5 Tests)
Each Kit Includes
▪ Test Cassette
▪ Extraction Reagent Tube
▪ Sterile Swab
▪ Waste Bag
▪ Instructions for Use
Warnings and Precautions
▪ For in vitro diagnostic use only
▪ Do not use this test as the only guide to manage 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
▪ 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
• Negative test results do not exclude infection with COVID-19 (so face masks, social distancing and good hygiene practice must be maintained)
• Positive test results or symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.
It is designed as a self test for patients. For best performance, it is recommended this test be used within 7 days post-onset of symptoms.
Storage and stability
Store the kit at 2 30 °C / 36 86 °F and protect from direct sunlight. The expiry date of the materials is indicated on the external packaging.
Do not freeze the kit.
Therapeutic Goods AdministrationCOVID-19 rapid antigen self-tests that are approved in Australia
The TGA has approved this COVID-19 self-tests (home use tests) for supply in Australia from 7th January 2022:
Name of self-test: Clungene Covid-19 Antigen Rapid Test for self-testing
Sample Type: Nasal swab
Australian Sponsor (Supplier): APAC Security Pty Ltd
Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)
Clinical Sensitivity: Very High Sensitivity (Highest Rating from TGA)
Date Approved: 7th January 2022