Talking about home testing for HIV

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Bad Jo



Worthless and useless??

As long as Im searching independently assesment of BioSure kit as Im in more doubt about product reliability. First is this:
Than anonimous post hard to confirm but worth to read about user V comment:
Than finally from this page:
I know that information would be probally ignored or not treated seoriusly but it’s wort to know. It shows this product as not so great as described on website.


***Note from PEBL:  Thanks for posting on PEBL. This is  a very important issue.  Please scroll down to read other comments, including the full response posted by BioSureUK .

5 Responses

Becky, BioSure UK Ltd
 Work on 31st July 2020

Hi Shocking, No problem. Thank you kindly for your support. All the best, Becky

 Used on 30th July 2020

Hi becky, many thanks for your prompt reply. And thank you for the great work you and your colleagues do on this forum.

Becky, BioSure UK Ltd
 Work on 30th July 2020

Hi Bad Jo, Firstly I would like to start off by saying that we of course take this feedback into great consideration so thank you. We understand that some people may have doubts about self testing and worry that the accuracy of these tests may be tainted due to the fact that an untrained user performs the test themselves. Please be assured that when we first launched our self test back in 2015, all associated risks of someone receiving a false result were assessed greatly to minimise the risk of what someone may do if they receive a false result. We continue to provide clear instructions so that the end user is able to precisely follow the instructions and subsequently receive a reliable result. If someone happens to receive a positive result using our test, they must get this confirmed by a healthcare professional. There is advice and information on our product insert and IFU that instructs someone of what to do if they happen to receive a positive result. We are available Monday-Friday 9-5pm to answer any queries, confirm tests results or help to ease anxiety around testing. We are also have a WhatsApp help line available 24/7. The BioSURE HIV self test continues to meet all the necessary regulatory requirements and is CE marked. The test has a proven clinical sensitivity of 99.7% and a clinical specificity of 99.9%, without meeting certain accuracy requirements, we would not be allowed to market the medical device. A study performed remotely, assessed the ability of lay users using our test to follow instructions, perform the test and correctly interpret its results. It found that 97-98% achieved a valid result. We understand again that people may be sceptical about the test itself but we have continuously internally assessed the ability of untrained users to use the test and receive a reliable result. We also did a study with SELPHI whereby we offered free HIV self testing kits to users who subsequently gave data about the usability of the test. SELPHI is Europe's largest evaluation of effectiveness and impact of HIV self testing. The study found that people who did receive a positive result did self refer themselves for help, which supported the worries about whether someone would seek treatment following a positive HIV diagnosis. Regarding the Health News Review post, the section that states self testing is ineffective for early diagnosis, may be true however we make it very clear to the end user that their result is not conclusive until 12 weeks post exposure. Our self test is second generation and has a window period of 12 weeks. Anyone is able to test at anytime during the window period but they must retest at 12 weeks for a conclusive result. Our performance evaluation studies have shown that at 6 weeks, 95% of people will have detectable levels of antibodies for our test to give an accurate result. Everyone produces antibodies at different rates and therefore we have to be inclusive of everyone and say 12 weeks, however a result at 6 weeks is a very good indication. People who have recently had a risky exposure who enquire about using our test are always encouraged to get a test done at a clinic so they are able to access treatment sooner if their diagnosis is positive. Our test is used by many who simply may be worried about an exposure they had a while ago and consequently their anxiety is running wild. It truly does help to test and put your mind at rest once you receive that negative result. Our test is one of a kind in the sense that it has a built in sample control line. This essentially means that if the test is faulty or the user has not performed the test correctly, the control line will be absent and therefore it will be very clear to the user that the test result is invalid. We remain truly dedicated to being able to provide a safe and reliable self test that users can do in the comfort of their own home, with results in 15 minutes. No questions, no labs, no waiting. Again, we understand that some do not like the idea of self testing, but testing for HIV is the only way to know your status. Self testing although some may be sceptical, continues to help those who are afraid of going to the doctors, those who want their results there and then and those who simply would prefer to do it themselves rather than using healthcare resources. In response to the PEBL thread that is linked above, the person who originally left the comment has not responded since but as mentioned, although false negatives do occur using our test these are very rare and usually occur most when testing inside of the window period. The fact that all 5 tests were performed way outside of the window period would indicate that the negative results are highly accurate which leads us to believe that the lab tests is a false positive result. We will of course investigate this matter further and if we are able to get in contact with the commenter we will offer another testing kit to ensure his result is confirmed. Thank you for your feedback. Kindest regards, Becky

Becky, BioSure UK Ltd
 Work on 30th July 2020

Hi Shocking, If all 3 negative results were received outside of the window period then your negative results are accurate and conclusive. HIV infection begins with the virus entering your body, antibodies are produced in response to the virus. After around 1-3 weeks after infection, the seroconversion period begins. This is the time that most people experience symptoms such as fever, fatigue, muscle aches and pains etc. Shortly after, the person will become asymptomatic - usually leading people to believe it was just a random cold/flu. If your symptoms have persisted for 3 years, I would not put this down to HIV but I would always recommend to speak to your doctor regarding your symptoms, if you haven't already. Kindest regards, Becky

 Used on 30th July 2020

This is extremely worrying. I have had continuing symptoms for near 3 years after a high risk exposure - non since. I have posted queries on a number of occasions and been told repeatedly by Gary and Becky that my 3 negative biosure tests outside the window period are conclusive. In a proper state of panic now!!!

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