BioSURE HIV Self Test


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The BioSURE HIV Self Test is proven to be easy to use by untrained users and is 99.7% accurate. It is an easy to use HIV test that delivers quick results in 15 minutes.
• Minimum Order Quantity (MOQ): 100 tests
• Seller Name: BioSure
• Seller Location: United Kingdom
• Warranty Term: Not applicable
• Regulatory Approval: CE, Ghana FDA, ISO 13485, Kenyan Pharmacy and Poisons Board, MHRA, Brazilian Health Ministry

Additional information

Weight 3.9 kg
Dimensions 34.5 × 25.5 × 40.0 cm


BioSURE HIV Self Test was the world's first approved HIV self-test to use blood. Available in 3 continents, this test needs only 2.5 microlitres of blood and no measuring or mixing is required. It gives an incredibly accurate and easy-to-read result in 3 simple steps and in just 15 minutes. Extensive research and data has proven its accuracy and usability.

Key Features

This test is easy to use and interpret thanks to the clear and simple instructions provided with each test. It only requires a 2.5uL blood sample (fraction of a drop of blood). It does not require any mixing or measuring.

Users will appreciate the discrete nature of the packaging and test. The BioSURE HIV Self Test puts individuals in charge and allows them to discreetly determine their HIV status at a time and a place that is convenient for them.



  • Sensitivity: 99.7%
  • Specificity: 99.9%

Standard Accessories

Not applicable

Optional Accessories & Add-ons

Not applicable

Product Documents, Manuals & Brochures



Regulatory Certificates

CE Certificate

ISO 13458 Certificate

Kenyan Pharmacy and Poisons Board Certificate

Kenya Ministry of Health Validation Certificate

Brazil Health Registration Certificate



How does the BioSURE HIV Self Test work?

The technology is very similar to a human pregnancy test but detects specific antibodies to HIV in a blood sample. When the body detects something harmful (like a bacteria or a virus), the immune system starts to produce antibodies to try and defend the body. Each type of antibody is unique, and each individual makes them at different rates.

How accurate is the BioSURE HIV Self Test?

It is proven to be extremely effective at diagnosing HIV. Extensive research has evidenced this kit to be exceptionally usable and tremendously accurate when performed correctly.
It has a proven clinical sensitivity (if a person has HIV how often the test will be positive) of 99.7%, this means that on average 997 in every 1,000 positive results will be correct.
It has a proven clinical specificity (if a person doesn’t have HIV how often will the test be negative) of 99.9%, this means that on average 999 in every 1,000 negative results will be correct.

About the HIV testing window

4 weeks after exposure about 50% of people have made the antibodies for HIV. By 6 weeks after exposure, this goes up to about 95%, however, some people don’t make these antibodies until up to 12 weeks after infection. It’s important to ensure that test users do not rely on a negative test result until 3 months after their most recent possible exposure.

Studies & Trials

Available upon request


Package Contents

  • 1x BioSURE HIV Self Test Pouch Containing:
    • 1x BioSURE HIV self test device
    • 1x Single-use safety lancet
    • 1x Plaster
  • 1x Instructions for use and result guide
  • 1x Product insert
  • 1x Opaque disposal bag
  • 1x Pack of desiccant


Not applicable


Not available at this time