Talking about home testing for HIV

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Concerned

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7

Storage of HIV self-test kit

When I conducted the HIV self-test I followed the step-by-step instructions carefully. After 15 minutes there was only one line which means that the test result was negative. Finding this out by using the HIV self-test was great news and a relief.

However, since taking the test I have been worried because when the HIV self-test kit arrived I stored it over night in the attic room where the room temperature dropped to below 8 degrees. It was freezing outside but I don’t think the temperature in the attic room where the kit was stored got as low as freezing. Can I be confident in my negative result even though your guidelines say that the kit should be stored at room temperature, 8-25 degrees?

7 Responses

Francesca Bard, BioSure (UK) Ltd
 Work on 03rd July 2018

Hi Chiwa, is it the BioSURE HIV Self Test that you are storing and using? If it is another brand it is not approved or regulated and is very likely to give you a false test result (ie a negative result when the person actually has HIV), because they give a negative result even if you do something wrong. Our test will only give you a negative result if you have applied enough blood, done everything correctly and you do not have antibodies to HIV. However, our BioSURE test should not be stored in high temperatures above 30C because it can damage the way the test works and give you an incorrect result. Perhaps you could consider getting a test in a clinic? If you do want to self-test please only used an approved HIV self test (in South Africa, BioSURE is currently the only approved test available for sale) so you can be sure of your result. I hope this helps . Kindest regards, Francesca Bard, BioSure (UK) Ltd

Chiwa
 Used on 01st July 2018

So meaning to store the hiv home test kit in hot place can not damage as long as the validity is not over for 2 months, you can still use it and it will give right results? The box out says 37°C. Does it mean cold or hot since I used the 1 I putted in a hot wardrobe , some of my body part are burning like my low back, tight also my buttox , knee. stomach burning. I still test negative

Gary Carpenter, BioSure (UK) Limited
 Work on 02nd March 2018

Hi MROS Thanks for getting in touch and sorry for the slow response. Storing at temperatures of greater than 30 degrees C will damage the biochemistry in the test and renders any test result invalid. One of the things that happens when the test is stored at high temperatures is an increased likelihood of a "False Positive" result i.e. a positive result when the person is actually HIV negative. I think that this has happened in this case. If you have two negative results from different places I would say that your HIV status is negative. I hope that this helps answer your question. Kind regards Gary Carpenter BioSure (UK) Limited

Mros
 Used on 28th February 2018

Hi I'm concerned I stored HIV test kits in my wardrobe for 5 days and temperatures were higher than (hot) 0-37 zero Celsius. And I used it and it shows 2 lines. The next day I bought new one and it give me the the result of one line - negative result. After 3 months I test at the clinic and it's give me a negative result. I'm confused please help me.

Gary Carpenter, BioSure (UK) Limited
 Work on 16th February 2017

Hi Concerned Sorry for not responding sooner to your question. We differentiate between storage and transit. The storage conditions indicate how the test should be stored for long periods of time, anything up to the shelf life of the product, which can be as much as two years. The test can be temporarily exposed to different temperatures during transit from one place to another. We have to evidence that the test can withstand the "stress" of any reasonably predicted transit process. These stability studies require keeping the test at various temperatures (-8 degrees to up to +45 degrees) over a period of about a month. After this process the performance of the test is measured to ensure that the variation in environmental conditions has not been adversely affected. So we are sure that your test will have been unaffected by it's journey through the post. I hope this helps and once again really sorry for the slow response. Kind regards Gary Carpenter BioSure (UK) Limited

Concerned
 Used on 11th February 2017

Thank you for explaining that the test is not damaged by storing at lower than 8 degrees. Can you explain why the booklet mentions storing it at room temperature, 8-25 degrees?

Gary Carpenter, BioSure (UK) Limited
 Work on 08th February 2017

Hi Thanks for contacting us. The test is not damaged by storing at lower than 8 degrees. You need to run the test at room temperature. If you run the test when it's cold it will take a long time to run. You got the control to come up after 15 minutes then you have run the test correctly. I hope that this answers up your question. Kind regards Gary Carpenter BioSure (UK) Limited

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