The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published guidance dedicated to in vitro diagnostic (IVD) self-tests intended to be used for diagnosing seasonal influenza. The document outlines the expected clinical performance requirements and also the approach to be applied by the medical device manufacturers in order to mitigate the risks associated with such products. 

Regulatory Background

As mentioned, the document highlights the main regulatory requirements IVD self-tests should meet in terms of clinical sensitivity and specificity, as well as measures to be taken by the manufacturers for the reduction of risks arising when such tests are being used for their intended purpose. In particular, the guidance emphasizes the most important risks and highlights the regulatory requirements the medical devices in question should meet in order to be eligible for inclusion in the Australian Register of Therapeutic Goods (ARTG), the country’s national register of medical devices, and other healthcare products. Inclusion in ARTG is a mandatory condition for a medical device to be allowed for marketing and use in Australia. 

The authority also mentions that issues related to the analytical performance studies or product stability studies fall outside the scope of the present guidance. The TGA provides references to the separate guidance documents addressing the aspects outlined above. 

According to the document, the regulatory requirements for in vitro diagnostic self-tests are based on the following regulations:

– The Therapeutic Goods Act 1989,

– The Therapeutic Goods (Excluded Purposes) Specification 2020, and 

– The Legislative Instruments Act 2003.

The TGA provides a brief overview of the regulatory development process and describes interconnections existing between the aforementioned regulations. For instance, the TGA states that any tests allowed under the Excluded Purposes Specification 2020 can only be supplied following evaluation of individual products by the TGA to ensure appropriate clinical performance requirements are met, and risk mitigations are in place. 

The scope of the present TGA guidance covers only the in vitro diagnostic self-tests intended to identify seasonal influenza, while the ones intended to be used in the context of novel or emerging influenza fall outside the scope of the aspects addressed in the document. In particular, the guidance describes the approach to be applied with regard to IVD self-tests intended to be used to identify seasonal influenza (the flu), a viral infection widespread in winter. The TGA emphasizes that the seasonal viruses are similar, which makes it possible to apply a similar approach to the medical devices intended to be used in such context. The guidance also contains general information and statistics on seasonal influenza, the way it spreads, affected population groups, and approaches to be applied to mitigate the risks associated thereto. 

A special regulatory framework for seasonal influenza self-tests has been introduced by the virtue of the Excluded Purposes Specification 2020 effective from October 2020. According to the regulation,  legal supply of influenza self-tests may improve access for testing among priority populations, and allow self-test kits to be safety and legally distributed in Australia. The regulating authority also emphasizes the importance of ensuring and expanding the availability of self-test kits for public health in general. 

Regulatory Requirements on Clinical Performance and Risk Mitigation

According to the present TGA guidance, any and all self-tests intended to be marketed and used in Australia should comply with applicable regulatory requirements in terms of clinical performance when used for the intended purpose. The particular regulatory requirements to be applied depend on the class of the in vitro diagnostic medical device in question under the risk-based classification. The TGA states that the following aspects should be considered: 

  • The intended purpose of the test;
  • The format of the test;
  • The environmental conditions under which the test would be conducted by a lay person; and
  • The specimens type. 

The authority also mentions that in the case of in vitro diagnostic devices, the question is always in establishing the proper balance between the accuracy of the results the test provides and the ease of use by persons having no special qualifications or knowledge. 

According to the document, the appropriate Essential Principles should also be applied, namely:

  • Each medical device should be developed in a way ensuring it operates as intended by the manufacturer and in accordance with the specific purpose of being used by lay person. In particular, the manufacturer shall duly implement measures to mitigate to the lowest extent possible the impact of the variations in the use of the self-test device.
  • The instructions for use, as well as the labeling placed on the device and its packaging, should contain information provided in a clear and understandable way in accordance with the knowledge of the potential users. 
  • The design of the device should incorporate elements intended to reduce the errors resulting from the incorrect use of the device or interpretation of the results provided. 

Thus, when determining the eligibility of the medical device in question for inclusion in the ARTG, the regulating authority would consider the points above, as well as compliance of the device with other Essential Principles and regulatory requirements applicable thereto due to its class and intended purpose. 

Clinical Requirements

The present TGA guidance also describes in detail the clinical requirements to be applied for the seasonal influenza self-tests. The applicable regulatory requirements are based on the presumption that such tests are intended to be used in a home or other non-clinical environments by persons having no special knowledge or qualifications. This also impacts the way the test results should be interpreted and the actions to be taken in this regard. In particular, the TGA states that the positive result provided by the self-test should be subject to additional confirmation by laboratory tests that provide more accuracy. At the same time, should the initial test result be negative, while the person still faces the appropriate symptoms, it is necessary to contact healthcare professionals. 

Influenza self-tests described in the present TGA guidance are mostly antigen tests since the antibody detection approach should not be applied due to its specific feature – it provides accurate results only on a certain point and could be used only as a source of retrospective information. 

The document also outlines the particular clinical requirements the self-tests should meet in order to comply with the applicable regulatory requirements, namely:

  • Overall clinical sensitivity of at least 85%, and
  • Overall clinical specificity of at least 95% for the detection of influenza infection. 

In Summary, the present TGA guidance highlights the main aspects to be considered by the manufacturers of the in vitro diagnostic self-test medical devices intended to be used in the context of seasonal influenza. The document describes the applicable regulatory requirements and the approach to be applied when applying for inclusion in the Australian Register of Therapeutic Goods in order for the self-tests to be allowed for marketing and use in Australia. 

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