What is a regulated HIV Self Test?

Posted by Brigette Bard on

South African Pharmacy Council

  • Test must be CE marked or FDA approved as a self test
  • To gain CE marking a test must have gone through a user study to evidence that untrained people from a variety of backgrounds, can perform the test and read the result as accurately as a trained healthcare professional
  • There can be no deviation from the product sold in Europe as sold in South Africa
  • The product must go through European batch certification and be certified
  • A professional test cannot be repackaged and sold as a self test

Pre test counselling

Through our work with the Clinician Society, we agreed 5 key points that an end user needs to be aware of

  • HIV is a treatable condition
  • A person will get their result while they wait
  • The importance of the window period
  • The test is voluntary
  • A positive test result must be confirmed by a healthcare professional

These points are iterated throughout our packaging and on our product sleeve that gives additional information including signposting and a card to take to clinic

BioSURE HIV Self Test

We are responsible and aim to set and keep the bar as high as possible to engender trust in the HIV self testing market.

We aim to raise awareness that HIV is a treatable condition BUT only when you know your status. People ask about fear and self harm, but it is much better to deal with an HIV positive test result than to not know your status. A false negative result is the very worst outcome. Virtually all HIV tests work by detecting antibodies. People produce these at different times after infection, but by 3 months everybody will have seroconverted. This is why we state a 3 month window period. 

We are the world’s first approved HIV self test to use blood. We work with stakeholders globally and across South Africa and have generated large evidence and data about the acceptability of self testing for HIV and the usability of our BioSURE HIV Self Test.




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