So this is going to be a bit of a rant - but ultimately we might need your help, because at the end of the day the only person who really, truly is impacted by your self test is you....

If you read any of our blogs, you’ll know we are passionate about what we do. You are at the heart of everything we do; from our product development to how we communicate, because we care deeply and we want you to have genuine confidence in the choices you make - how you test, how you cope with your result, how you continue from there. We also want you to have the easiest to use test and get a true and accurate result that you can trust. But not everyone thinks the same way....

As self-testing for HIV becomes more common place, the rules are being re-interpreted. As the first ever approved kit to use blood, it was our job to set the bar and we decided to set it as high as we could, we believed it was critical if we were going to build a credible new market from scratch. A truly vital part of HIV self-testing is that you have to know if you’ve done your test correctly, so if you’ve not performed a part of your test correctly you should not get any result. The only way to do this is to have a true Sample Control Line.

We have dealt with thousands of your questions over the past four years and one of the most common is, “have I done my test correctly?” We can confidently say that IF you have got at least one line on your BioSURE test, then yes you have, because if you do something wrong; maybe don’t add enough blood or don’t push your test in far enough then NO LINES WILL APPEAR.

But the global stakeholders and some Notified Bodies, even the very top ones, don’t seem to understand this. They honestly think people will ‘just know’ if they’ve done their test correctly, that they have added enough blood. I have seen first-hand multiple times, HIV self-tests run with no blood at all that have given a clear negative result - one was with a journalist who ran her test with just a tea bag. Now you may think, ‘who could possibly run a test without blood?’ but given that in some countries there is an oral fluid test available it is very possible that someone could swab their mouth with their test instead of using blood - and they’d still get a clear negative result regardless of whether or not they had HIV. Also, all blood-based tests require a certain volume of blood (ours is only 2.5 micro litres but some are up to 50 micro litres) to trigger a valid result. One test that is available simply says to ‘make sure the pad is red’, but how can you ‘just know’ if it’s enough as you are going to get a result regardless? Can you imagine how you would feel having no way of knowing if you’d done your test correctly?

Although people think a false positive result is the worst outcome, false negatives are far more dangerous because a person will not go for confirmatory testing, may never test again and is likely to unknowingly pass the virus on through unprotected sex as they will not actually know their true status. In countries where prevalence is high (South Africa for example) it wouldn’t be a huge leap for incorrect results to actually lead to an increase in HIV.

So I’m not sure what you can do to help, but getting everyone to know this fact is really important. We have to do something, because the ‘experts’ aren’t listening, it is another ‘tick box’ exercise. Please ask questions, start conversations, especially on social media. We know how powerful our individual voices are from the changes we have already made, collectively we might just be able to protect people in counties outside of our own from being given tests that could actually put them at increased risk. Please join our army of HIV warriors, there is an epidemic to finish after all.

Thank you for reading.
Brigette Bard x