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Post market review of COVID-19 point-of-care tests

Information on our post-market review of all approved COVID-19 tests and post-market evaluation of all approved serology-based COVID-19 point-of-care tests.

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The TGA post market review of all serology-based COVID-19 point-of-care tests included in the ARTG to verify their performance is now complete.

The TGA contacted all sponsors of serology-based COVID-19 point-of-care tests included in the ARTG to request information on the performance the devices; the device instructions for use and distribution; and samples of the devices for testing. The performance of the samples provided was evaluated by the Doherty Institute and the results were published on the Department of Health website for each sponsor. The list below provides the link to the results and any regulatory or other action taken.

Although this component of the review is complete, the TGA is continuing the post-market review against the COVID-19 variants.

In response to the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) is currently undertaking an expedited approval process for inclusion of COVID-19 tests on the Australian Register of Therapeutic Goods (ARTG). Inclusion on the ARTG is based on certified manufacturer’s evidence and studies provided at the time of application. Supply of test kits can only occur under certain conditions, including that further information must be provided to the TGA to support the performance of these devices.

The TGA maintains a list of the sponsors (the person or company legally responsible for the product) of COVID-19 tests, including point-of-care tests, that are currently available and included on the ARTG. COVID-19 point-of-care tests included on the ARTG can only be supplied to, and are intended for use by, healthcare professionals. The majority are serology-based tests, which rely on the detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) (antibodies to COVID-19).

Accurate identification of a COVID-19 infection based on serology results, particularly those obtained from rapid tests used at the point-of-care, requires an understanding of the antibody response profile. There is a high likelihood of obtaining a false negative result if testing is performed in the early stages of infection, before an individual has developed antibodies. There is also evidence that some individuals may not develop antibodies to COVID-19. Therefore, an additional condition has been imposed on serology-based COVID-19 point-of-care tests to ensure that they are only supplied to, and used by, specified health professionals (e.g. medical practitioners) who can provide appropriate advice and treatment if required. For further information, see Legal supply of COVID-19 test kits.

The TGA is now reviewing all serology-based COVID-19 point-of-care tests included on the ARTG to verify their ability to detect antibodies to COVID-19, taking into consideration the timeframes for an individual to develop detectable levels of antibody.

The Peter Doherty Institute for Infection and Immunity (the Doherty Institute) has been engaged by the Department of Health to assist with the post-market validation of these tests to inform their best use. Other evaluations undertaken by Australian laboratories, or evaluations performed on behalf of other international regulators, may be taken into consideration by the TGA.

The TGA has contacted all sponsors of serology-based COVID-19 point-of-care tests currently included on the ARTG to request they provide further information about the devices, their distribution, and samples of these devices for evaluation.

Once the Doherty Institute validations are completed, the following list will show any regulatory or other action taken.

We anticipate that following the review of the devices included on the ARTG there will be a clearer understanding of the role these tests may play in the management of COVID-19.

Post market review results and actions taken

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