I recently used a test kit to check my hiv status. I am concerned that my test may not have been carried out properly. When I started my test, I didn’t realise until after the first 15 minutes that the test wasn’t running due to the fact that I hadn’t pushed it into the buffer solution properly. On realising this, I pushed it in and I gave the test a shake which lead to some of the buffer solution being spilled. The test appeared to run because I saw a control line appear quickly enough. I then left the test lying flat on a table for a further 15 minutes. After checking, there was only one line – the control line. No test line. It appeared as a negative result but I’m just anxious because I made the mistake for the first 15 minute and then I had shaken the test and laid it down flat instead of upright. Does this matter? Is my test result still valid when I got a solid control line despite everything that I did wrong? My potential exposure to hiv was a year ago so I know I’m outside the window for testing and any result should be correct. I’m just worried I might have made a mess of my test and afraid to trust the results. I also took a dr thom saliva test which was negative but I’m still anxious because of the mistakes made during my test. I’m not sure if shaking it or laying in down flat would cause a negative result or prevent a positive result from appearing. Your help and advice would be much appreciated for peace of mind.
Gary Carpenter, BioSure (UK) Limited
Work on 12th December 2018
Thanks for contacting us again.
Having read all of the posts in this conversation I would like to reassure that the test procedure and the subsequent result that you have described entirely reliable. The test is very robust to minors errors of procedure. Processing errors sometimes mean that the test doesn't run perfectly, but as long as you have a strong control line at the 15 minute mark, then this proves that the test has run correctly. These minor errors of test procedure do not affect the result.
Your negative test result should be considered accurate and reliable.
I know that I haven't answered your questions directly but I hope that this post is helpful and is sufficiently reassuring.
Head of Clinical and Regulatory Affairs
BioSure (UK) Limited
Used on 11th December 2018
Thank you for your explanation and reassurance. There was just one last thing that worried me about my test. While it was running, I noticed a little bit of faint pink colour, almost like a dot, at the Corner of the test line. This dot seemed to wash away as more buffer fluid moved through the test and did not stick. Maybe it was some blood snagging as the test was running but it made me worry because it was at the edge/corner of the test line (not on the line or across it).. However, after the 15 minute period, only the control line was solid and visible. There was no solid or visible line on the test line, despite there being the spot of pink colour that appeared at the edge of it during the running of the test. If my test had been positive, would it be right to say that a solid/complete visible line would have appeared on the test line? Not just a dot at the corner that appeared to wash away? The snagging at the edge of the test line worried me and played on my mind but it washed away and I was definitely left with only a solid control line meaning a negative result. I'm sorry for all of my questions but this has played on my mind and I just need some final peace of mind.
FRANCESCA BARD, BIOSURE (UK) LTD
Work on 11th December 2018
As long as you have a negative control line the fact you didn’t see the test running would not have affected the running of the test. This line is there as a precaution and to allow the user to see if their test has worked, it can ONLY appear if the test has worked correctly. The main reason for our 15 minute read time is due to the possibility of having a faint positive line, after 15 minutes the background discolouration would’ve cleared making even the faintest line visible. Although we recommend not reading your result more than an hour after running the test, the test is stable and the result shouldn’t change. I hope this helps put your mind at rest. Kindest Francesca, BioSure (UK) Ltd
Used on 07th December 2018
Thank you for your response and reassurance regarding my test and anxiety. I just have a couple more questions. Does it matter that I didn't notice the test was running for the first 15 minutes and then I continued to wait a further 15 minutes? What I mean is, would that have lead to me missing a second line appearing at any stage because my entire testing experience lasted 30 minutes and not 15? I did notice some pink coloration on the edge of the test line during the test but that seemed to wash away when more buffer solution passed through the test and wasn't there after 15 minutes of running the test. I also checked the test the next day and the control line was still the only solid visible line. If there was a second line, would it be solid and remain fixed after the 15 minute period? I'm sorry for all my questions but I struggle with anxiety and this has been a worry to me for some time and I just need to be sure that I can trust my test results.
Also, would the fact that I had shaken the test and or the fact that too much buffer solution may have been absorbed from shaking cause my test to be invalid? I'm just worried that even though a control line appeared quickly and that would indicate my test is valid, I'm still concerned if there was a possibly that shaking it or laying it down instead of upright may have lead to a second line being washed away. Would a second line, if I had appeared, been firm and solid and still been visible after the 15 minutes? I had no second line and like I said previously, I only saw a very clear firm solid control line from the start of the test and after, even on the next day.
Francesca Bard, BioSure (UK) Ltd
Work on 07th December 2018
Hi Judy18. Yes, your assumption is correct. A negative test result is conclusive 12 weeks post possible exposure, given your exposure was a year ago this is a conclusive negative result. We all have many worries in our lives however for you HIV isn't one. I hope this helps put your mind at rest. Kindest Francesca Bard, BioSure (UK) Ltd
Used on 07th December 2018
Thank you for your response. So does this therefore mean that I can be sure that my result using the biosure test kit was negative and reliable? I just want to put my mind at ease and stop feeling anxious or worrying about taking a second test.
Francesca Bard, BioSure (UK) Ltd
Work on 04th December 2018
Hi Judy18. Your test has worked due to you receiving a negative test line, this is a control line that is there to ensure the user that the test has worked correctly. Laying the test down would not cause the test to not work, it may just mean that the result takes longer to show (15 minutes as opposed to a couple of minutes to see a result). I would recommend looking to see if a Dr Thom Saliva Test is registered and has CE marking as this means that the accuracy has been proven (this is extremely important when buying an HIV self test). I hope this helps and thank you for choosing BioSure. Kindest regards Francesca Bard, BioSure (UK) Ltd