The purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s (TGA) expectations concerning performance requirements (i.e. analytical and clinical sensitivity and specificity) and risk mitigation for in vitro diagnostic medical devices (IVDs) intended to be used as seasonal influenza rapid antigen tests.
For manufacturers and sponsors of combination rapid antigen tests that are intended to detect multiple respiratory targets such as influenza A, influenza B, SARS-CoV-2 and/or respiratory syncytial virus (RSV) in a rapid antigen test format (combination RATs) both at the point-of-care (POC) and for self-testing, the influenza-specific requirements outlined in this document are applicable to the device and should be considered in conjunction with the SARS-CoV-2-specific performance requirements and risk mitigation strategies relevant to COVID-19 rapid antigen tests.
This document details key risks that must be mitigated and identifies conditions that may be imposed on these self-test kits if they are included in the Australian Register of Therapeutic Goods (ARTG). Additional risks and mitigation strategies, including conditions of inclusion may apply to individual devices on a case-by-case basis.
- Notification form
- Regulatory background on self-tests to detect seasonal influenza
- Public health context
- Regulatory requirements for rapid antigen self tests to detect seasonal influenza
- Performance characteristics and risk mitigation strategies for IVD self-testing
- Analytical requirements
- Clinical requirements
- Usability studies
- User comprehension
- Inter-reader variability
- Invalid test rate
- User sensitivity/specificity studies
- Additional risk mitigation strategies for self-tests
- Requirements for the instructions for use (IFU)
- Associated software and mobile applications
- Post-market monitoring and standard conditions of inclusion
- Additional conditions that may be applied
- How to submit an application to the TGA for IVD self-test to detect seasonal influenza