Simplitude™ ByMe™ is a rapid, at-home diagnostic test that detects antibodies against human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). The test material is a fresh whole blood sample obtained from a fingertip prick taken immediately before the test. The "All in One" test device combines a test chamber to which the test sample is applied and from which the result is read with a pipette for collecting a blood sample and a lancing device.

What is human immunodeficiency virus?

There are 2 types of human immunodeficiency virus (HIV) - HIV-1 and HIV-2. This is a virus that attacks the immune system and over time reduces the body's ability to fight infection. When you are infected with HIV, your immune system produces specific antibodies against one, the other, or both types of the virus. If HIV is not treated, it can lead to acquired immunodeficiency syndrome (AIDS). Currently, there is no effective drug that can permanently cure HIV infection, but with proper treatment it can lead to a non-life-threatening condition. With early diagnosis and treatment, the life expectancy of a person infected with HIV can be similar to that of a person who does not have HIV.

When is HIV testing recommended with the Simplitude™ ByMe™ Kit?

It can take 6 to 12 weeks from the time of exposure to HIV (the virus enters the body) to the time when antibodies appear in the blood. This period is called the so-called serological window. Carrying out an HIV test at home during this period can lead to a false negative result. For this reason, the timing of the test is so important, which will allow preliminary determination of human immunodeficiency virus infection.

The Simplitude™ ByMe™ self-administered HIV test is designed to detect antibodies in human blood that appear as a result of infection with any type of virus. This is a unique screening test that provides results in 15 minutes and should be performed no earlier than 6 weeks after exposure to HIV infection.

Simplitude™ ByMe™ rapid immunochromatographic in vitro diagnostic test intended for home use by unqualified users as a self-administered test to support the diagnosis of HIV-1 and HIV-2 infection. The accuracy of the test was determined to be 99.6%. The test package was accompanied by the so-called Assistance Card, which provides the contact details of local institutions that provide support to people infected with HIV or who may come into contact with the virus. If a positive result is obtained, it must be confirmed by a doctor based on additional tests.