I did the biosure test , as routine , feeling confident that the result would be negative. It came out positive . After a sleepless night I went straight to the local NHS STI clinic the following morning and was retested by a healthcare professional. The result was negative , explain that 😤
Gary Carpenter, BioSure (UK) Limited Workon 13th October 2017
Firstly, we're really sorry that this has happened. Unfortunately, as much as we would like it not to be the case, no test is perfect. Sometimes the test will give the wrong result. As part of EU law for diagnostic tests we have to report product failures to our Notified Body, the people that gave us our CE mark and allow us to place the product on the market.
Improving our product is really important to us so we're really grateful for getting in touch and bringing this to our attention. We will try to investigate what went wrong. But there are a number of reasons why your test may have been a false positive result. Sometimes autoimmune conditions such as rheumatoid arthritis or lupus can be the cause. Sometimes it just a fluke of nature. We don't claim that the device will be perfect all of the time. In fact to date we have delivered around 60,000 tests of which we have had 9 false positive results reported to us.
It is great that you were able to link to care so seamlessly and really pleased that you got a resolution.
If you have any other information that you could share that may help us with our investigation into this issue, perhaps we could have an offline conversation.
Again, sorry and thanks for getting in touch.
BioSure (UK) Limited