A rapid antigen test sitting on a dining table next to cutlery

A rapid antigen test is a quick and simple way to assist NSW Health in identifying COVID-19 in those who don't have any symptoms.The Therapeutic Goods Administration has announced it will make a new regulation to allow companies to legally supply their self-tests for use at home in Australia from 1 November 2021.

Information derived from NSW Government Website

What is a Rapid Antigen Test?

Rapid antigen testing involves a small nasal swab that is placed into a chemical solution The result displays within 10 to 15 minutes.  It exists to help health services in finding COVID-19 in those who might not necessarily have any symptoms. 

Accuracy of Rapid Antigen Tests

It is important to remeber that Rapid antigen tests will detect most cases of COVID-19 but are not as accurate as the standard Covid-19 test. If you develop physical symptoms or are identified as a close or casual contact of someone who has COVID-19, you must get tested at a clinic and self-isolate. Do not use a Rapid Antigen Test in this instance.

Therapeutic Goods Administation Regulations 

To make sure there remains a safe use of rapid antigen self-tests, the Therapeutic Goods Administration (TGA) has announced it will make a new regulation to allow companies to legally supply their self-tests for use at home in Australia from 1 November 2021.

Individual tests will require TGA approval and must be included on the Australian Register of Therapeutic Goods (ARTG) as for all other testing kits. The TGA continues to work with suppliers and manufacturers of self-tests to ensure:

  • instructions for use are written in a way that all consumers can understand
  • usability testing has been successful
  • self-tests perform satisfactorily against variants such as Delta.

An important step in implementing the use of these tests at home includes enabling any consumer who has a positive rapid antigen test result to immediately have a confirmatory test at a state run COVID-19 testing clinic.

Under current arrangements, the Therapeutic Goods Administration conditions of supply require rapid antigen tests to be used under the supervision of a health practitioner who has been trained in the correct use of the device and interpretation of results. 

Trained staff can perform the test if they are supervised by a health practitioner, either in person or via video. 

 

The tests will be sold in pharmacies, supermarkets, including Coles and Woolworths, and other retailers both in-store and online.

What to do with a Positive Rapid Antigen Test

If you get a positive rapid antigen test result, you must:

  • immediately get a standard COVID-19 test at a specified NSW testing clinic to confirm the result of your screening test
  • isolate until you get a negative result from NSW Health.

Do you have Symptoms?

According to the NSW Government Website, Rapid antigen testing is not appropriate if you have any symptoms of COVID-19. You must get a standard COVID-19 test at a COVID-19 testing clinic in NSW and isolate, including from your household members, until you receive a negative result.

The only way to rule out COVID-19 is to have a standard test, even if you have only mild symptoms.

More Information

Therapuetic Goods Administration

Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 
Phone: 1800 141 144 

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