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Chlamydia, gonorrhoea and syphilis IVD self-tests

Clinical performance requirements and risk mitigation strategies
18 March 2021
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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).

  • 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
  • Usability studies

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