Detecting negative samples: The Simplitude™ ByMe™ self test for HIV has been shown in laboratory testing to correctly identify 99.6% of HIV negative samples (1757 of 1764). This is known as the test’s specificity. This means that, on average, for every 1,000 negative samples tested, 996 will be detected correctly. Detecting positive samples: The Simplitude™ ByMe™ self test for HIV has been shown in laboratory testing to correctly identity 99.6% of HIV positive samples (904 of 908). This is known as the test’s sensitivity. This means that, on average, for every 1,000 positive samples tested, 996 tests will be detected correctly. Testing was performed with samples from high prevalence regions (South Africa) and from low prevalence regions (Europe).

2 x Instructions for Use (IFU) / Instruction Leaflet. One UK and one German version. 1 x HIV self test device (in foil pouch with desiccant) 1 x Bottle of Test Fluid (diluent) 1 x Disposal Bag for discreet disposal 1 x Care Card for links to follow-up care 1 x Adhesive bandage

The Simplitude™ ByMe™ self test for HIV is a single-use screening test. Each test device can be used only once, and it must be disposed of after use.

Place the test in the disposal bag provided. The bag can then be sealed and thrown away with household rubbish.

Antiretroviral therapy is the use of HIV medicines to treat HIV infection. The medicines do not kill or cure the virus but when taken in combination they can prevent the growth of the virus. The HIV Self Test is not suitable for people taking antiretroviral medication.

The test has an integrated safety lancet for pricking the finger and obtaining a blood sample: the lancet is sterile. The green sterility tab ensures that the lancet remains clean and sterile before use.

First turn the green sterility tab at least 90 degrees, then pull it out.

Don’t worry; pricking your finger is quick and easy and you will feel only a slight pinch at your fingertip. You will not see the needle before or after it has pricked your finger.

Have you pushed the grey button all the way in? If no, try it again. Push hard and make sure that the grey button is fully retracted. Note that this is a single-use test and it will prick the finger only once. If yes, squeeze your finger firmly to help form a blood drop. Squeeze from the base of the finger and massage towards the fingertip. If still no blood is present on your fingertip, stop: you will need to start again with a new test.

The blood tube is straw coloured. Fill the blood tube completely; it measures the correct amount of blood. If your skin touches the tube it won’t affect the result. Do not put the blood into the hole in the grey button. Do not put the blood directly into the well on the top of the test cassette.

If blood smears on your fingertip, wipe your finger clean, then squeeze your finger firmly again to form a new blood bubble. Make sure to squeeze your finger from the base and to massage towards your fingertip. Ensure your finger is pointing downwards. When a bubble of blood forms on your fingertip, gently touch it to the tip of the tube. The blood will be drawn into the tube. If you don’t have enough blood to fill the blood tube completely, wipe your finger clean, then squeeze your finger firmly again to form a new blood bubble. Make sure to squeeze your finger from the base and to massage towards your fingertip. If you still don’t have enough blood to fill the tube completely, the test result won’t be accurate. Stop: you will need to start again with a new test.

Blood should fill the tube from end to end. The tube collects exactly the right amount of blood needed for the test. The tube will stop filling when it is full: it is not possible to overfill it.

Make sure the blood tube is completely full. Blood should fill the tube from end to end. Make sure that the tube has been rotated fully so that it touches the well in the top of the test cassette: it will click into place. If the blood still won’t move to the well, stop: you will need to start again with a new test.

You need to add 4 drops of test solution to make the test work. The drops must be added to the well in the top of the test cassette after you have rotated the blood tube and it has clicked into place. Don’t shake the bottle of test solution: doing so will create air bubbles. Point the bottle downwards and squeeze firmly. Count the drops as they are delivered: 1, 2, 3, 4.

Make sure you wait 15 minutes before reading the result. Do not wait longer than 20 minutes. Lines that have appeared next to the ‘T’ or ‘C’ symbols on the test cassette will tell you your result. The instruction leaflet includes red, orange, and green boxes that explain how to interpret your test result. Put your test against each box in turn to find the one that matches your result. You will also find information on reading your result in the ‘About Your Result’ section of the instruction leaflet.

This test looks for antibodies your body produces in response to HIV. It can take up to 12 weeks after any exposure to HIV for your body to produce these. This time is called the 'window period. If you use an HIV self-test during the window period, you may get an incorrectly negative result. If you believe you have been recently exposed to HIV, it is recommended that you seek advice from your doctor or a healthcare professional and use an HIV self-test only after the window period has passed.

It is important to know if it has been more than 3 months since your last risk event. If it has, and you have performed the test correctly, you are likely to be HIV negative. If it has been less than 3 months since your last risk event, you will need to test again in 3 months. If you are unsure, you should seek advice from your doctor or a healthcare professional. Please refer to the enclosed Care Card for links to local advice and support services or visit www.simplitudebyme.com for more information about accessing follow-up testing. A negative result does not at any time preclude the possibility of HIV infection. If the test result is negative and clinical symptoms are present, additional testing using other clinical methods is recommended.

Don’t panic. The Simplitude™ ByMe™ self test for HIV is a screening test and a positive test result does not necessarily mean that you have HIV. If the test result is positive, you need to go for follow-up testing at a healthcare facility. Please refer to the enclosed Care Card for links to local advice and support services or visit www.simplitudebyme.com for more information about accessing follow-up testing. HIV is a manageable condition, and HIV is not a barrier to a long, active and healthy life. Your doctor will ensure this, and might also recommend a local HIV support service. People living with HIV are now put on treatment immediately, which prevents any damage to your body and when taken long-term will ensure you can't pass it on to anyone else.

The test will not give a result if it is not performed correctly. You will need to start again using a new test device or speak to your doctor or healthcare professional for follow-up testing.

If you see a line next to the ‘C’ symbol on the top of the test cassette it means you have performed the test correctly. If you see a line next the ‘C’ symbol on the top of the test cassette but you are not sure if you have performed the test correctly, please refer to the following trouble shooting questions.

Is the product expiry date current? (This is given on the box and on the foil pouch.) Was the foil pouch and test fluid bottle packaging in good condition, i.e., no tears, openings, etc? Was the test used immediately upon opening the foil pouch? Was the blood tube full? Did the blood move from the tube to the test strip after the tube was rotated? Were 4 drops of test solution (diluent) added? Did you use the test solution (diluent) that was provided with the test? Did you wait 15 minutes before reading the result? Did you read the result before 20 minutes had elapsed? If the answer is no to any of these questions, the test may not have worked correctly; in which case you should dispose of the test and perform another test using a new device or speak to your doctor or healthcare professional.

You will have two to four regular appointments a year at your HIV clinic to make sure your treatment is working properly and that you are well. Regular blood tests will check your CD4 count, your viral load, liver health and screen for STIs. Your urine may sometimes be tested to check for diabetes and the health of your kidneys. How often you need tests or appointments will depend on how long you have been on treatment, how well you are and whether you are pregnant.

The most recent statistics suggest there were just over 100,000 people living with HIV in the UK, including 7,500 undiagnosed people who are HIV positive. People living in London, men who have sex with men, and black African people are disproportionately affected: 34% of people with new diagnoses that year were living in London of the 4,453 people diagnosed with HIV in the UK in 2018, 51% were gay or bisexual men Of the 1,550 heterosexual people diagnosed with HIV in 2018, 413 were balck African men and women

U=U stands for undetectable equals untransmittable. It is a hugely influential campaign based on a solid foundation of scientific evidence. Individuals with HIV who take antiretroviral therapy (ART) and have achieved and maintained an undetectable viral load cannot sexually transmit the virus to others. Campaign messaging is designed to challenge social stigma and fear around transmission, build self-esteem of individuals with HIV and continue to improve the treatment of HIV infection. Find out more about U = U.