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HIV self-tests available in Australia

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One HIV self-test is approved for use in Australia, the Atomo HIV Self Test. Conditions which placed limitations on the supply of this self-test changed on 22 October 2021 to improve the accessibility of HIV testing. The limitations on its supply were eased following further studies demonstrating the preferences, acceptability and significantly improved usability of this HIV self-test.

It is now easier for Atomo to supply their HIV Self Test through online purchases, over-the-counter sales in pharmacies and to other relevant businesses, organisations and institutions that work with HIV at-risk communities including gay, bisexual, and other men who have sex with men (GBM). The advertising permission for HIV self-tests was also updated to permit broader use of prohibited and restricted representations in marketing material associated with HIV self-testing.

Pharmacies and other organisations that supply the Atomo HIV Self Test must have information available to ensure individuals can perform the test correctly and interpret the test result accurately. Every test comes with information about how to access support services, by phone or in person.

The following conditions are imposed on HIV self-tests included in the Australian Register of Therapeutic Goods (ARTG)

Supply

  1. The person in relation to whom the HIV self-test (the device) is included in the Australian Register of Therapeutic Goods (the sponsor) must ensure that the device is only supplied to one or more of the following:
    1. a business, organisation or institution (including a pharmacy) that employs or engages individuals who have received appropriate training (in any form) in relation to the correct use and performance of the device, and the interpretation of the test result;
    2. a person directly through the website of the sponsor or a pharmacy mentioned in paragraph (a).

Customer support services

  1. The sponsor must publish on its website a simple, clear and effective instructional video, demonstrating the correct use and performance of the device, and the interpretation of the test result.
  2. The sponsor must:
    1. provide information about relevant support services and confirmatory testing available in each state and territory with the supply of each device; and
    2. publish the information mentioned in paragraph (a) on its website.
  3. The sponsor must take steps to ensure that a business, organisation or institution (including a pharmacy) mentioned in condition (1)(a) has access to, and encourages the dissemination of, the following by any means:
    1. information about the correct use and performance of the device, and the interpretation of the test result, consistent with the information provided in the instructional video mentioned in condition (2); and
    2. information about the support services and confirmatory testing mentioned in condition (3).
  4. The sponsor must provide a telephone helpline that:
    1. provides customer support about the correct use and performance of the device, and the interpretation of the test result; and
    2. operates (as a minimum) between 9 am and 7 pm (AEST), or 9 am and 8 pm (AEDT), 7 days per week.
  5. The sponsor must ensure that the operators providing customer support services mentioned in condition (5) have received training in the delivery and administration of HIV testing, in accordance with the requirements of the National HIV testing policy (which may be accessed via the ASHM website at https://www.ashm.org.au).

Post market surveillance reports

  1. The sponsor must provide a post market surveillance report, containing the following information, to the Therapeutic Goods Administration (at the email address postmarketdevices@health.gov.au) for each reporting period specified in condition (8), before 1 October after that reporting period:
    1. the numbers of tests sold both in Australia and overseas;
    2. any adverse events, including numbers of any reported false positive or false negative results, both in Australia and overseas;
    3. reported problems, issues or complaints associated with the use or interpretation of the device, both in Australia and overseas.
  2. Each of the following is a reporting period:
    1. the period beginning on the day when this condition is imposed, and ending at the end of the next 30 June;
    2. each of the next five financial years.

Record keeping

  1. The sponsor must maintain records that demonstrate that the sponsor has complied with each of the conditions mentioned above (relating to supply, customer support services and post market surveillance reports) and provide those records to the Secretary on request.

HIV tests in Australia are in vitro diagnostic (IVD) medical devices. They must be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia. There is a strong emphasis on ensuring that information provided in the instructions for use (IFU) of an HIV self-test includes clear, easy-to-follow steps so the user knows how to perform the test and interpret the results correctly. Detailed information on how to contact support services must also be provided. Guidance produced by the TGA explains the expectations of manufacturers and sponsors of HIV tests to meet clinical performance requirements and have risk mitigation strategies in place.

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