Mylan HIV Self Test

Mylan HIV Self Test is the world’s 1st integrated blood based HIV self-test device that offers untrained users, simple at-home HIV screening test with result in just 15 minutes.

blood based rapid hiv self test




  • 3rd Generation HIV Self-Test
  • Designed for at-home Self-Test
  • Removes need for multiple test components
  • Simplifies test procedures
  • Improves test accuracy

Easy Interpretation of Result

The test result is displayed clearly in just 15 minutes.

Easy Blood Delivery

Blood is delivered cleanly to the test strip by simply rotating the blood collection unit.

Built-in Safety Lancet

The auto-retracting safety lancet eliminates the risk of hazardous sharps injuries by locking the needle inside the device after use for safe disposal.

Accurate Blood Collection

The easy-to-use blood collection unit is designed to collect exactly the right sample volume (10μl), ensuring optimal test performance.

Recognized for its innovative design

Mylan HIV Self Test manufactured by Atomo Diagnostics, Australia and marketed by Viatris, has been recognised internationally for innovative design, performance and ease-of-use.

Approved by multiple regulatory authorities

CE Approved

(Conformité Européenne)

TGA Approved

(Therapeutic Goods Administration, Australian Government Department of Health)

WHO Approved

(World Health Organisation)

Gives accurate result3

Gives accurate result


(ability to correctly identify HIV positive samples)

Gives accurate result


(ability to correctly identify HIV negative samples)

Easy to use

Important Note: Wash and dry hands before performing the test.
Instructions for use that comes with the pack should be read carefully before performing the test.

Easy to interpret result in just 15 minutes

HIV negative

If one line appears at the C, you tested HIV negative.
There must be no line at the T.

This is a screening test.

Test again after 3 months.

HIV negative
Test did not work

If no line appears at the C, the test did not work.

This is a screening test.

Go to a clinic for further testing.

HIV Test did not work
HIV positive

If two lines appear,
if faint, you tested HIV positive.

This is a screening test.

Go to a clinic for further testing.

HIV positive

C: Control; T: Test

Important Note: Instructions for use that comes with the pack should be read carefully before performing the test.

Watch the step by step test procedure video

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About HIV & HIV Self Test

What is HIV?4

HIV (Human immunodeficiency virus) is a virus, that targets the immune system and weakens people’s defense against many infections and some types of cancer. As the virus destroys and impairs the function of immune cells, infected individuals gradually become immunodeficient. Immune function is typically measured by CD4 cell count.

Immunodeficiency results in increased susceptibility to a wide range of infections, cancers and other diseases that people with healthy immune systems can fight off.

What is AIDS?4

The most advanced stage of HIV infection is acquired immunodeficiency syndrome (AIDS), which can take many years to develop if not treated, depending on the individual. AIDS is defined by the development of certain cancers, infections or other severe long term clinical manifestations.

HIV can be transmitted through5

Sexual contact


Sharing needles to inject drugs

Sharing needles
to inject drugs

Blood transfusion


Hiv Transmitted Mother to child

Mother to child
during pregnancy
birth or breastfeeding

How is HIV transmitted?5

Body fluids from HIV infected people
Blood, semen, pre seminal fluid,
rectal fluids, vaginal fluids, breast milk

Contact with a mucous membrane (found inside the rectum, vagina, penis, and month).
Damaged tissue.
Directly injected into bloodstream.

Risk factors4

Behaviours and conditions that put individuals at greater risk of contracting HIV include:

  1. having unprotected vaginal or anal sex
  2. having another sexually transmitted infection such as syphilis, herpes, chlamydia, gonorrhoea, and bacterial vaginosis
  3. sharing contaminated needles, syringes and other injecting equipment and drug solutions when injecting drugs
  4. receiving unsafe injections, blood transfusions, tissue transplantation, medical procedures that involve unsterile cutting or piercing
  5. experiencing accidental needle stick injuries, including among health workers

How can be HIV diagnosed?4

HIV can be diagnosed through rapid diagnostic tests that provide same-day results. This greatly facilitates early diagnosis and linkage with treatment and care. People can also use HIV self-tests to test themselves. However, no single test can provide a full HIV diagnosis; a confirmatory test is required, conducted by a qualified and validated health worker at a community centre or clinic. HIV infection can be detected with great accuracy using WHO prequalified tests within a nationally approved testing strategy.

Most widely-used HIV diagnostic tests detect antibodies produced by the person as part of their immune response to fight HIV. In most cases, people develop antibodies to HIV within 28 days of infection. During this time, people experience the so-called “window” period – when HIV antibodies haven’t been produced and when they may have had no signs of HIV infection, but also when they may transmit HIV to others. After infection, an individual may transmit HIV to a sexual or drug-sharing partner or for pregnant women to their infant during pregnancy or the breastfeeding period.

What is the HIV Self Test?

HIV Self Test is a process in which a person collects their own specimen (oral fluid or blood) using a simple rapid HIV test and then performs the test and interprets their result, when and where they want.6

Mylan HIV Self Test is intended to be used by untrained lay users in a private setting as a self test to aid in the diagnosis of infection with HIV-1 and HIV-2 from samples of fresh, whole blood obtained through a finger stick blood collection technique.1

What happens if my test result is NEGATIVE?1

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, then you are likely to be HIV negative. If it has been less than 3 months since your risk event, you need to test again in 3 months. If you are unsure, seek advice.

What happens if my test result is POSITIVE?1

Being HIV positive is a manageable condition and people living with HIV are able to live long, active and healthy lives. Mylan HIV Self Test is a screening test and getting 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. Early diagnosis of HIV means treatment can start sooner.

Only your doctor or healthcare professional can recommend what treatment is right for you. If you are diagnosed as HIV positive, you will be connected to counselling services and, dependent on your condition, may be given antiretroviral (ARV) treatment.

What happens if my test doesn’t work?1

The test will not give a result if it is not performed correctly. You need to repeat the test using a new test device. If you are unsure if you have performed the test correctly, please speak to your doctor or healthcare professional.


  1. Data on file.
  2. Atomo diagnostics.HIV self testing. Available at :; Accessed on 9 June 2020
  3. WHO PQ Public Report; Version 1.0; July 2019. Available at: 191003_amended_pqpr_0320_090_00_mylan_hiv_self_test_v2.pdf?ua=1; Accessed on 26 June 2020
  4. HIV/AIDs_Key Facts; 15 November 2019. Available at :; Accessed on 9 June 2020
  5. Centers for Disease Control and Prevention. HIV Transmission. Available at:; Accessed on: 24 June 2020.
  6. WHO recommends HIV Self-Testing – Evidence update and considerations for success, November 2019 ; Available at :; Accessed on : 24 June 2020
Download Informational Brochure(Select Language)

The 'instructions for use' document in languages other than English is a translation of the approved English version. While all care has been taken in ensuring accuracy in translation, in the event of any conflict, the English version shall prevail.


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