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In Australia, all COVID-19 testing kits must be approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied. The TGA has approved 32 different tests for use in Australia. These tests are required to comply with the essential principles for safety and performance, as set out in the Therapeutic Goods (Medical Devices) Regulations 2002. For example, instructions for use must be written in a way that all consumers can understand. All approved tests are listed on the COVID-19 test kit page, with approved self-tests and point-of-care tests separated.
| Characteristics | Values |
|---|---|
| Test kit approval body | Therapeutic Goods Administration (TGA) |
| Register of approved tests | Australian Register of Therapeutic Goods (ARTG) |
| Sensitivity requirement | At least 80% |
| Packaging and labelling | Must comply with TGA-approved versions |
| Instructions for use | Must be written in a way that all consumers can understand |
| Number of approved tests | 32 |
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What You'll Learn
- TGA approval and ARTG inclusion are mandatory for legal RAT sales in Australia
- RAT tests are not as sensitive as PCR tests, so negative results may be false
- RAT tests are best used to confirm COVID-19 when symptomatic
- Approved RAT kits must meet criteria for usability, instructions, and performance
- Price gouging on RATs is illegal in Australia
TGA approval and ARTG inclusion are mandatory for legal RAT sales in Australia
In Australia, all COVID-19 test kits must be approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied and sold in the country. The TGA approval process ensures that all rapid antigen tests (RATs) meet specific criteria for safety and performance, and effectiveness.
The TGA has strict requirements for RATs to ensure their accuracy and reliability. For instance, all approved RATs must have a sensitivity of at least 80%. This means that while a positive result on a RAT is highly indicative of a COVID-19 infection, a negative result does not rule it out completely. To increase the confidence in a negative result, individuals are advised to perform multiple RATs over a period of time.
The ARTG maintains a list of all approved COVID-19 test kits, including both point-of-care tests and self-tests. Point-of-care tests are conducted outside of a laboratory setting by trained health practitioners or staff, while self-tests are designed for home use. It is important to note that some RATs included in the ARTG are specifically approved for point-of-care use only and are not intended for home testing.
To ensure compliance with TGA regulations, RAT manufacturers and sponsors must adhere to specific guidelines. Any changes to the packaging or labelling of medical devices must be approved by the TGA, and instructions for use must be provided with the tests. These instructions should be written in a clear and understandable manner for consumers. Failure to comply with these requirements may result in legal consequences.
In summary, TGA approval and ARTG inclusion are crucial steps in ensuring the safety and efficacy of RATs available in Australia. By mandating these regulatory processes, the Australian government aims to protect public health and provide reliable testing options for its citizens.
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RAT tests are not as sensitive as PCR tests, so negative results may be false
In Australia, all COVID-19 test kits must be approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in the country. The TGA has published instructions for use that must be supplied with COVID-19 rapid antigen self-tests that are approved in Australia.
Rapid antigen tests (RATs) are less sensitive than PCR tests and require more viruses to detect an infection. This means that RATs are more likely to produce false-negative results, especially during the early stages of infection. For example, 1 in 4 tests on people symptomatic for COVID-19 return a false negative, and it can take 3-4 days after symptoms start for a RAT to be positive. In contrast, studies suggest that the sensitivity of PCR tests, or the rate at which they correctly identify those with the virus, may be somewhere between 85% and 98%, with a recent study estimating around 95%.
Due to the lower sensitivity of RATs, confirmatory testing with more sensitive methods, such as PCR tests, may be necessary in symptomatic cases. This is especially important if you are living, working, or entering high-risk settings such as those with vulnerable populations, age care, and healthcare. If your RAT results are negative but you are experiencing symptoms, you can request a PCR test from your GP.
To reduce the risk of an infection being missed, or a false negative, it is recommended to perform repeat RAT testing over consecutive days. An infected person will test positive on a PCR test one to two days before a RAT. RATs accurately detected around 81% of positive cases in earlier variants such as Delta, but estimates for Omicron are lower and less consistent between studies. Results vary depending on the stage of infection, degree of symptoms, and the individual kit used, among other factors.
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RAT tests are best used to confirm COVID-19 when symptomatic
Rapid Antigen Tests (RATs) are an important tool in the fight against COVID-19, especially as we navigate an eighth wave of infections in Australia. While RATs are less sensitive than PCR tests, they offer the advantage of at-home testing and rapid results. The primary use of RATs is to confirm a COVID-19 infection when symptomatic, helping individuals take prompt action to prevent further spread.
When an individual experiences respiratory symptoms indicative of COVID-19, such as a cough, fever, or sore throat, a RAT can provide a quick and convenient means of verification. If the RAT result is positive, it is highly likely that the individual has COVID-19, and they should immediately begin self-isolation to reduce the risk of transmission. Additionally, seeking antiviral medications is advisable if they meet the eligibility criteria. Oral antiviral medicines, such as Lagevrio® and Paxlovid®, are available on the Pharmaceutical Benefits Scheme (PBS) in Australia and are subsidised for those with a Medicare card. These antivirals work best when taken as soon as possible, preferably within 5 days of the onset of symptoms.
However, it is important to note that a negative RAT result does not rule out COVID-19 infection. To increase confidence in a negative result, it is recommended to perform multiple RATs at regular intervals. For instance, if an individual is symptomatic and tests negative, they should retest after 48 hours and, if necessary, a third time after another 48 hours. This serial testing approach enhances the reliability of the results and helps individuals make informed decisions about their health and interactions with others.
In Australia, the Therapeutic Goods Administration (TGA) is responsible for approving COVID-19 RATs. To be legally supplied in the country, all testing kits must be included in the Australian Register of Therapeutic Goods (ARTG) and meet specific criteria. These criteria include providing understandable instructions for use, successful usability testing, and satisfactory performance against variants like Delta and Omicron. As of 2024, 32 different RATs have been approved for use in Australia, ensuring broad access to testing and helping to curb the spread of COVID-19.
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Approved RAT kits must meet criteria for usability, instructions, and performance
In Australia, all COVID-19 testing kits must be approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in the country. Approved RAT kits must meet specific criteria for usability, instructions, and performance.
Firstly, RAT kits must undergo successful usability testing. This involves assessing whether the instructions for use are written in a clear and understandable manner for all consumers. The instructions must also be supplied with the devices and comply with the TGA-approved versions. The absence of appropriate instructions for use may result in legal repercussions for the supplier.
Secondly, RAT kits must meet performance standards. All RATs approved by the TGA must have a sensitivity of at least 80%. Additionally, the tests should perform satisfactorily against variants such as Delta and Omicron.
The TGA provides a COVID-19 test kit page where all approved RAT kits for point-of-care testing and self-testing are listed. This allows consumers to verify the approval status of the RAT kits they purchase and ensures compliance with the essential principles for safety and performance as outlined in the Therapeutic Goods (Medical Devices) Regulations 2002.
It is important to note that price gouging on RATs has been an issue in Australia during surges in Omicron cases, with prices marked up by more than 20%. Consumers are advised to compare prices between providers and only purchase from reputable Australian providers, especially when buying online, to avoid price gouging and unapproved tests.
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Price gouging on RATs is illegal in Australia
The Australian Federal Police (AFP) has confirmed that price gouging on rapid antigen tests (RATs) is illegal in Australia. The AFP has launched investigations in Queensland and New South Wales following referrals from the Australian Competition and Consumer Commission (ACCC). The ACCC has received hundreds of reports of price gouging, with pharmacies being the worst offenders, making up 47% of the reports, followed by convenience stores, tobacconists, and supermarkets.
Under Australian law, price gouging occurs when an individual or business buys a RAT kit from a retailer and resells it for more than 20% of the purchase price. This practice is illegal, and those found guilty may face jail time of up to five years and fines of up to AUD 66,000. The AFP has established a dedicated team to investigate these cases and protect the public from unlawful greed.
All COVID-19 test kits sold in Australia must be approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG). The TGA has published instructions for the use of RATs, and suppliers are required to provide these instructions with the test kits. The instructions must be written in a way that all consumers can understand.
The cost of RATs can vary, with 2-packs retailing for around $20–$45, and 5 and 10-pack options also available. When purchasing wholesale, the price is typically $8 to $15 per pack, but individual purchases may be more expensive. It is important to compare prices between providers to ensure you are not paying too much and to only buy from reputable Australian providers, especially when buying online.
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Frequently asked questions
All COVID-19 testing kits require approval from the Therapeutic Goods Administration (TGA) and inclusion in the Australian Register of Therapeutic Goods (ARTG) to be legally supplied in Australia. Approved kits must meet the following criteria: instructions for use are written in a way that all consumers can understand, usability testing has been successful, and self-tests perform satisfactorily against variants such as Delta and Omicron. All RATs approved by Australia’s Therapeutic Goods Administration must have a sensitivity of at least 80%.
All tests sold in Australia must be approved by the TGA. The TGA publishes a list of all COVID-19 test kits approved for inclusion in the Australian Register of Therapeutic Goods (ARTG) on its COVID-19 test kit page.
If you have any concerns about how COVID-19 rapid antigen self-tests are being sold in retail outlets, you can report a perceived breach or questionable practice to the TGA.
If you record a positive result on a rapid antigen test, you are encouraged to contact your GP for the next steps. A positive test should prompt you to isolate, and if you’re eligible, to seek antivirals.
There are a few situations where determining your COVID status is important to inform your actions, particularly during an uptick in infections. Testing is especially important if you have respiratory symptoms and are infectious, if you've come into contact with someone with COVID, or before attending large social gatherings.
