The TGA is reviewing all COVID-19-specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-tests, included in the Australian Register of Therapeutic Goods (ARTG). The purpose of the review is to determine if tests have been impacted by the current known variants of SARS-CoV-2, with ongoing activity to assess their ability to detect emerging variants. Show In addition, the post-market review includes laboratory testing of all point of care (PoCT) and self-test RATs included in the ARTG to validate their performance in detecting the Delta and Omicron variants (and other emerging variants of concern). A variant of the virus arises from mutations in the SARS-CoV-2 virus of the genome and may alter the structure of the expressed viral protein. As a result, test kits may no longer be able to sensitively detect the virus, leading to false negative results. Manufacturers of these kinds of tests have provided the TGA with study data to validate the performance of their test kits, including recombinant protein studies, live virus studies, inactivated virus studies, and clinical studies. Note: Manufacturers are required to undertake proactive monitoring to ensure their tests are not impacted by the variants of the virus. TGA testing of RATsAs each Variant of Concern (VoC) emerges, the manufacturer is expected to undertake an analysis, in line with their risk management plans, to verify that their tests continue to perform as intended, and that any adverse impacts are identified and communicated to users and regulatory authorities. As an additional measure, the TGA has commissioned the Peter Doherty Institute for Infection and Immunity (the Doherty Institute), in collaboration with the National (Serology) Reference Laboratory (NRL), an operating division of St Vincent's Institute of Medical Research, to undertake laboratory testing. This is to verify the manufacturer's claims regarding the analytical sensitivity (Limit of Detection - the lowest concentration at which an analyte can be detected (LoD)) for SARS-CoV-2 (wild-type - original SARS-CoV-2 strain) and the Delta and Omicron variants, with scope to expand testing for additional VoCs as they arise. In order to demonstrate compliance with the Essential Principles, the test kits must meet the sensitivity requirements as set out in the World Health Organisation (WHO) guidelines. The TGA has published guidance COVID-19 Rapid antigen self-tests - Performance on requirements and risk mitigation strategies outlining the expectation that all test kits included in the ARTG meet this requirement. The review is on-going and information about the performance of each RAT against the variants will be published on this webpage as it becomes available. Testing detailsThe WHO has published guidance about the minimum sensitivity requirements, where the LoD of all RATs must be no higher than 100 to 1,000 TCID50/mL (tissue culture infectious dose - TCID). The TCID50/mL is a measure used to quantify and assess viral levels, which allows the sensitivity of a kit to be evaluated. The TGA, in conjunction with the Doherty Institute and the NRL, has developed a protocol to assess the performance of RATs against the Delta and Omicron variants when compared to the sensitivity of the kit to the original strain of the SARS-CoV-2 virus. The Doherty Institute and the NRL will report the LoD for each of the kits, in units of TCID50/mL and viral copies/mL. All sponsors of RATs in the ARTG (both point-of-care and self-tests) have sent samples to the TGA for testing. If safety and performance concerns or non-compliance issues are identified through the post-market review processes, the TGA may undertake further regulatory action. This may include suspending or removing the devices from supply in Australia. TimeframesThe TGA, with the Doherty Institute and the NRL, are working as quickly as possible to undertake the testing to ensure the TGA can provide the most up to date information about the test kits' performance. Review statusResults from the TGA validation process are being released in the table below, as testing progresses. This public release of results occurs after the normal regulatory procedures of notifications to the sponsors of their results. Not all RATs have been assessed to date; the web page will be updated regularly as testing continues. Test results released below are current as of 29 July 2022. As of 29 July 2022, the manufacturers of the following test kits have provided analytical and clinical evidence, to support their performance with the variants specified below. The analytical evidence provided can be any combination of recombinant protein studies, inactivated virus studies, and live virus studies. Evidence provided by clinical studies is identified separately. Please note, the table below includes results from the Doherty Institute and NRL testing, and the manufacturer's data. Assessed RATs included in the ARTGThe TGA carefully reviewed the data submitted by manufacturers at the time of their application for inclusion in the ARTG. As a condition of inclusion, the TGA has required all manufacturers to continue providing data after approval, to demonstrate performance against variants of concern, and to show that they continue to meet safety and performance requirements. The data provided by manufacturers has included recombinant protein studies, inactivated virus studies, live virus studies, and clinical studies. Recombinant protein studies are considered to be acceptable preliminary evidence to support the performance and are considered initially acceptable evidence for variants of interest. However, to demonstrate performance for variants of concern such as delta and omicron, additional studies including inactivated or live virus studies, and clinical studies are required. The TGA is following up with all sponsors where only recombinant protein studies have been provided. The TGA has also undertaken additional validation testing to confirm the manufacturers' analysis. This involved third-party laboratory testing, where the TGA staff have worked alongside the Doherty Institute and the NRL. The table below will be updated with the results as they become available. The results of the LoD testing are presented as either:
As part of this testing, the RATs were also assessed for compliance with labelling requirements, and any potential design and quality defects were also identified. Any non-conformances identified are specified below under 'Device quality'. The test results have been certified by a responsible analyst under the Therapeutic Goods Regulations 1990. The TGA validation results do not replace the manufacturer's obligations to provide the TGA with their own evidence. In the table of results below, the TGA has also included the manufacturer's studies, as these have previously been published on our website. Where a test is identified as not performing as intended, or has a decrease in sensitivity, with a particular variant of concern, the TGA will specify this below. If the results are 'non-compliant', the TGA will investigate further to determine whether the deficiencies are related to an impact due to a variant, overall performance issue, or a batch-related issue. This result may suggest reduced sensitivity or inability to pick up positive results for patients in earlier stages of their infectious period for a particular variant, and not that the test is completely ineffective. If there are no results displayed with a particular variant of concern, the validation testing has not been completed. Note about symbols used in the table* Variants that have only been tested with recombinant protein studies. † Where multiple RATs are included under the one (1) ARTG number and have the same product composition, they have only been assessed once in the TGA testing. For example, if a product has a self-test and POCT version, only one was tested.
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