HIV (Human Immunodeficiency Virus) is the virus that causes AIDS (Acquired Immunodeficiency Syndrome) if left untreated.

When a person becomes infected with HIV, the virus begins to attack his or her immune system, which is the body’s defence against illness.

As a result, that person becomes more susceptible to disease and infection. When his or her body loses the ability to fight diseases, that person is diagnosed with AIDS. There is no cure for HIV infection. However, treatment for HIV is highly effective.

HIV spreads through contact with blood, semen, pre-seminal fluid, rectal fluid, vaginal fluids, or breast milk of an infected person. Transmission can occur from unsafe sex. It can also result from exposure to blood through the sharing of syringes or needles. Women living with HIV can pass the virus to their babies during pregnancy, childbirth, and breastfeeding. HIV is not
transmitted by casual contact (sharing food, dishes, clothing, etc.), saliva, casual kissing, food preparation or insect bites.

Antibodies are produced by your body’s immune system in response to harmful organisms like viruses and bacteria. Their purpose is to defend against infection.

INSTI HIV Self Test is a blood test for detecting HIV antibodies. The test produces a result in the form of either one dot (control dot) or two dots (control and test dots). A control dot is the built-in control mechanism and is visible if the test is performed correctly. A test dot will only be visible if sample contains antibodies to HIV. The test is performed by adding a drop of blood to Bottle 1. This diluted sample is then poured into the test device followed by solutions in Bottle 2 and Bottle 3, sequentially after each solution has absorbed through the test device. The test procedure must be completed in the proper sequence without delays between steps.

Based on a Canadian study on the INSTI HIV-1/HIV-2 Antibody Test, INSTI has a proven: clinical sensitivity of 99.6%, which means that if 1000 people with HIV antibodies are tested with INSTI, 996 will get a positive test result.Clinical specificity of 99.3%, which means if 1000 people without HIV antibodies are tested with INSTI, 993 will get a negative test result.

In another Canadian study conducted by self-testers, the positive percent agreement was 100%. This means all true HIV antibody subjects were identified as positive by the INSTI HIV Self Test. The negative percent agreement in this study was 99.5%, which means that 614/617 true HIV negative subjects were identified as negative by the INSTI HIV Self Test.”

A false positive result is when a test result is positive, but the true HIV status of the person is negative (not infected with HIV).

A false negative result is when a test result is negative, but the true HIV status of the person is positive (infected with HIV).

Based on bioLytical's studies, INSTI demonstrates third generation performance and detects HIV antibodies of the IgM and IgG classes. IgM antibodies are the earliest antibodies that the body produces after an HIV infection and can be detectable within 21-22 days1,2. Depending on how quickly a person’s immune system generates HIV antibodies after exposure, it could still take up to 3 months to get a positive result. If you think you have been exposed to HIV within the last 3 months, and your results are negative, you will need to test again after at least 3 months have passed since your exposure. The time from HIV exposure to when a test can correctly give a positive result is referred to as the ‘window period’.

Before starting the test, relax and drink a glass of water. Warm your hands. Place your hand below waist level to promote blood flow. Before using the lancet, look for a spot on the side of your finger tip that is smooth and not calloused and away from your fingernail.

It is very rare for this to happen, but if it does, you will not be able to complete the test rocedure and read the results. You will need to perform another test. In some instances, samples may exhibit longer than normal flow times through the test device. This is due to variable factors, such as cellular components within the whole blood sample. Failure to follow the instructions may also result in leakage and/or overflow of liquids from the test device.

Continue with the test procedure. The test result is valid as long as the control dot shows a visible dot after pouring Bottle 3 into the test device.

The INSTI HIV Self Test has a built in control dot to show that the test has been performed correctly and that you have added the proper sample type and amount of blood sample. If the control dot does not appear (invalid test result), your test has not worked. It is not possible to draw conclusions from this result and you will need to perform another test. In the event of repeated invalid results, consult a doctor.

You can read the result instantly or within 1 hour of completing the test procedure. Make sure the control dot is present before reading your result.

Make sure you have adequate lighting. If no dots are visible, you may not have completed the test correctly, or collected enough blood. You will need to perform another test.

A Positive Result: Consult a doctor as soon as possible and inform him/her that you have performed a self test for HIV. All positive results must be confirmed by a laboratory test. HIV is preventable and you must avoid high risk sexual behaviours to prevent passing HIV to your partner.

Having HIV does not mean you have AIDS. With early diagnosis and treatment, it is unlikely that you will develop AIDS. Discuss the next steps with your doctor or counsellor.

A Negative Result: As with many tests, there is a chance for false results. If you have a negative result but you were involved in an HIV-risk activity in the past 3 months, you could be in what is called the “window period” and it is recommended to repeat testing at a later date.

A false negative result can occur if:

You have been on long term anti-retroviral treatment.

You have a severe blood disorder, such as multiple myeloma.

You have higher than normal haemoglobin.

There are no other known interferences. It is recommended to read the manufacturers' instructions for other medications you are taking before conducting the test.