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.
For further information on overall technical documentation and clinical evidence requirements for in vitro diagnostics, please refer to the clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices, application audit (technical file review) of IVD medical device applications and guidance on the classification of IVD medical devices.
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