SURE CHECK^® HIV Self-Test

The SURE CHECK^® HIV 1/2 Self-Test is a rapid, single-use in-vitro diagnostic test that detects antibodies in your blood sample that are specific for HIV-1 and HIV-2 (not the HIV virus itself). These antibodies produce the TEST line.

The SURE CHECK^® HIV 1/2 Self-Test is intended to be used as a screening test for the lay user in diagnosing HIV-1 and HIV-2 infection. A positive result is preliminary and must be confirmed by a healthcare professional.

When a person becomes infected with HIV, it can take from 23 to 90 days* for their body to develop enough antibodies to be detected by an HIV antibody test. This is called the window period – the time between HIV exposure and when a test can detect HIV in your body. This period may vary, depending on the reaction of the individual’s body to the infection and the type of test.

* https://www.cdc.gov/hiv/basics/hiv-testing/hiv-window-period.html

It is possible for a person to test positive with an HIV antibody test in little as 23 days after infection*. However, everyone reacts differently to the infection, and it can take as long as 90 days to produce sufficient antibodies to produce a positive result. For that reason, if the SURE CHECK^® HIV 1/2 Self-Test is performed within 90 days of a risk event or exposure to HIV and the result is negative, you cannot be certain that you are HIV negative at this time. It is recommended to test again once 3 months have passed since your most recent risk of exposure to HIV.

* https://www.cdc.gov/hiv/basics/hiv-testing/hiv-window-period.html

The SURE CHECK^® HIV 1/2 Self-Test will start to run when the test device tip is fully pushed into the buffer cap. Check for a pink/purple flow on the test strip. If you do not see this coloring, push the test device deeper into the buffer cap. Please refer to the package insert for more detailed instructions and a pictorial description.

If the SURE CHECK^® HIV 1/2 Self-Test has run correctly, the CONTROL line will appear. If the CONTROL line does not appear, your test has not worked properly. Please discard your test and retest with a new device.

The SURE CHECK HIV 1/2 Self-Test is for single use and cannot be reused under any circumstances.

The safety lancet is designed for one time use only.

Extensive research has shown the SURE CHECK^® HIV 1/2 Self-Test to be accurate. Please refer to the package insert for more performance details. If you are unsure of your test result, please see a healthcare professional to perform another test.

If you have not had any risk events or HIV exposure in the past 3 months or beyond, and you followed the instructions for use carefully, then you are likely HIV negative. If you think you may have been exposed to HIV within the past 3 months, you should retest for HIV 3 months following the risk event.

A positive result means you are probably positive for HIV. You need to follow up with a healthcare professional to confirm the test result. At that time your healthcare professional will discuss the next steps that need to be taken.

A faint line should be interpreted as a positive result. The intensity of the test line does not necessarily correlate with the amount of antibody in the blood sample. You need to follow up with a healthcare professional to confirm the test result and discuss the next steps that need to be taken.

No, you cannot get HIV from using the SURE CHECK^® HIV 1/2 Self-Test. The test does not contain the active HIV virus.