I sincerely wish that I had never used this test
I sincerely wish that I had never used this test and had simply gone to my nearest GUM clinic in the first instance. The Terence Higgins Trust sent me a BioSure test free of charge via the post. It looked impressive and claimed to be 99.7% accurate. I read the test instructions carefully and followed them to the letter. To my horror the test showed a positive result, a weak pink line in the second ‘test’ position and a strong red one in the ‘control’ position, as indicated to be a Positive result by the third diagram in the test enclosure. I worried myself sick over this until I was able to ring my local GUM clinic in the morning. They were absolutely wonderful and tested me within an hour with a more accurate combined rapid test, and took samples to test via two different, more conclusive methods (ELISA and Western Blot). All three tests were completely negative and my terror had been for nothing. I had taken a picture of the completed BioSure test to show the health advisor and they confirmed that I had followed the instructions and read the result correctly: it was a faulty test, somehow. I have since learned that multiple people have experienced false positives with this test and I do not believe that it has the 99.7% accuracy claimed by the manufacturers, which is based on a sample group of only about 1100 trial participants (as stated in the leaflet accompanying the test). I strongly suggest that people contact their local Sexual Health Service for a free, accurate, evidence-based test done by a professional rather than putting themselves through the trauma of a false positive.
Gary Carpenter, BioSure (UK) Limited
Work on 06th April 2020
Thanks for your comments and sorry that your test didn't work as you expected. I really do appreciate your point of view and I do understand how traumatic a false positive result can be for some people. And it's true that I am a director of BioSure and I hope that this helps to underline how seriously the company views its obligations. We also do err on the size of caution when it comes to the advising people on how to interpret their test results, we require all test lines, no matter how weak the line, to be read as a positive result. This increases the likelihood of a false negative result. We can't require people to report false results to us, as we understand that a lot of people choose a self-test as they want the process to be in their control. But we do provide lots of mechanisms for people to get in touch with us, including this platform. We also have to accept that no test will be 100% accurate. We make it absolutely clear that this test isn't. Unfortunately, all tests will give incorrect results. It's also probably true that the number of false results are are under reported. However, we are part of the largest study into the impact of HIV self-testing that has been conducted in Europe. This study, which hopefully will report some of its findings this year, which does require participants to report their results. This study is completely independent of BioSure, we just supply and distribute the test, after that its out of our hands. They are required to report issues to us. We can't give out the numbers as it isn't our data to publicise, but I can say that there were 7 x more confirmed positives than false positives, with just over 16,000 tests sent out as part of this study.
Self-testing for HIV isn't for everyone. You need to weigh up the risk and benefit for you personally.
Your experience has been included in our post market surveillance data and will be reported to the MHRA.
I'm truly sorry that this test didn't work for you and wish you good health in these difficult times.
Head of Clinical & Regulatory Affairs
BioSure (UK) Limited
Used on 04th April 2020
I completely agree with you. I had a biosure test a week ago which came back positive (feint pink line). I called a sexual health clinic and went there the next day. The nurse who tested me the next day expected (to my surprise, given the biosure result) the test he did to be negative and it was! He told me he gets more false positives than positives from those who use self test kits.
I also read a document from the cdc (a health organization in the US) which states that those in groups where there are a very small minority of HIV positive people are more likely to have a false positive than a positive result, irrespective of how accurate these self test kit companies claim their kits are.
There is clearly a disconnect here between Biosure's research and the actual results. For example, how can Biosure know how many false positives there are when those who get false positives don't tell them but, instead, go straight to their local clinic, get retested and then move on with their lives rather than bother to notify Biosure? How on earth will Biosure know about these people? I don't see anything in their self test kit asking people to report false positives to them so how are they going to know? I'd love Biosure to answer this question. It is just a fact that Biosure has no idea of how many false positives there are in the world because they haven't created a system, other than their own small, controlled studies, to collect such data.
I appreciate Biosure wants to protect it's product for business reasons (I can see from Companies House that Gary Carpenter is a Director of the company) but getting a false positive is so traumatic and it's not fair for this company to not take responsibility for this and look into this. Here is one suggestion. Contact sexual health clinics and connect with nurses who administer HIV tests and ask them to keep a record of those who get false positives when they did the self test kit. If you were to do this your statistics on accuracy will change overnight.
Your statistics on accuracy, especially in terms of false positives is inaccurate. That's a fact.
Used on 08th July 2016
Hi Gary, I appreciate you having taken the time to reply to my experience; thank you. However, I must respectfully disagree with some of your assertions. According to your company's own published data, I calculate the claimed false positive rate for the BioSure test to be approximately 1 in 334 tests, or around 0.0299% on average. For those 35,000 tests conducted in the UK that you mention, that means that on average given a standard distribution of results one would expect at least 104 false positives to occur. To only receive 7 false positive reports (including mine) in 35,000 tests, just 6.73% of the probable false positives, would be more likely to suggest that false positives simply aren't being reported or aren't being solicited actively enough, rather than the test being astonishingly accurate. No HIV test could ever be that accurate; it is simply biochemically impossible. I fully accept that false positives occur in all HIV tests and that the BioSure test is potentially a useful tool if no better alternative is available. However, in the UK, there is general and comprehensive access to professional testing services where a range of different diagnostic methods can be combined to produce a more statistically meaningful result. At minimum, the documentation supplied with the test, particularly the reference diagrams, need to be updated to reflect the fact that a reactant test does not necessarily mean an HIV-positive status. Obviously the probability of a null result being a false negative is much lower, and indeed it is correct that the test should fail on the side of caution to positive; but certainly the "pink line" partial reactant result being classed as Positive should perhaps be relabelled "RETEST" or a similar phrase. Anecdotally however I hear from the sexual health service that I attended that they had seen three other BioSure test users who had false positive results in a short timeframe, which would also appear to make the notion of only seven false positive results having occurred since April 2015 unlikely. Whilst I appreciate that you have a product to market, I feel a little more effort to identify potential issues would be appropriate, given that this is an HIV test and not a consumer gadget. Thank you. Best regards, Ganymede
Gary Carpenter, BioSure (UK)
Work on 08th July 2016
I am sorry that you have received a false positive result with your BioSURE HIV Self Test. I know that this will have been a very stressful experience.
Unfortunately, rapid point of care tests, like the BioSure HIV Self Test, are not 100% accurate, and a false positive result is one of the possible bad outcomes.
About 35,000 of these tests have been used for self-testing since launch (April 2015) and so far we have had 7 reports of false positive results, including yours. Around 2 million are performed in the US by clinicians every year. The test is FDA and WHO approved as a professional use test.
We take your experience very seriously and I am sorry for the stress that you have suffered. But it isn't right to imply that the test is of poor quality or we have misled people with regard to it's accuracy. I can assure you that the tests that you took in clinic also suffer from false positive results. There are no perfect options, I'm afraid.
In order to beat HIV, we need to expand testing and to provide more testing options. The BioSure HIV Self Test is a very accurate, even if imperfect, part of that mix.
BioSure (UK) Limited