The purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration's (TGA) expectations concerning clinical performance requirements (i.e. clinical sensitivity and specificity) and risk mitigations for in vitro diagnostic medical devices (IVDs) intended to be used as self-tests for Chlamydia trachomatis (chlamydia), Neisseria gonorrhoeae (gonorrhoea) and Treponema pallidum (syphilis).
Contents
Purpose
Background
Public health context
Clinical performance characteristics and risk mitigation strategies for IVD self-testing
Clinical requirements for chlamydia, gonorrhoea and syphilis self-tests
