INSTI HIV self test


The INSTI HIV home test
Accurate result within 60 seconds
The only CE approved HIV Test Kit


HIV stands for Human Immunodeficiency Virus. HIV is the virus that causes AIDS (Acquired Immunodeficiency Syndrome) if left untreated. It is estimated that there are over 30 million people living with HIV in the world today, and up to half of those people have not been diagnosed and are unaware of their infection. This undiagnosed population accounts for most of the HIV transmissions worldwide. Treatment for HIV is highly effective. It is important to start treatment as early as possible following infection, to reduce the risk of serious illness or death.

Intended Use

The INSTI HIV Self Test is a single use, rapid, flow-through in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human fingerstick whole blood. The test is intended for use by untrained lay users as a self test to aid in the diagnosis of HIV-1 and HIV-2 infection using a small drop (50?L) of blood obtained through fingerstick collection procedures.

Biological Principles Of The Test

The INSTI HIV Self Test is an immunoassay for detecting HIV antibodies. The test device consists of a synthetic membrane positioned atop an absorbent pad within a plastic cartridge. One section of the membrane has been treated with non-hazardous HIV-1 and HIV-2 recombinant proteins, which capture HIV antibodies (test dot). The membrane also includes a control dot treated with protein-A that captures other non-specific antibodies normally present in human blood. The test is performed by adding a fingerstick blood sample to Bottle 1. The diluted blood in Bottle 1 is poured into the well of the test device. Any HIV antibodies in the sample are captured by the test dot and non-specific antibodies are captured by the control dot. Bottle 2 is then added to the test device. Bottle 2 solution reacts with captured antibodies to produce a blue dot at control dot and, if HIV antibodies are present, a blue dot also appears at test dot. In the final step, Bottle 3 is added to the membrane to make the control and test dots more visible.

Materials Provided

  • 1 Instructions for Use
  • 1 Pouch with test device (labelled Membrane Unit)
  • 1 Sample Diluent (Bottle 1, red top)
  • 1 Colour Developer (Bottle 2, blue top)
  • 1 Clarifying Solution (Bottle 3, clear top)
  • 1 Sterile single-use lancet ( 0050)
  • 1 Adhesive bandage
  • 1 Resources Card

Test device (packaged inside the pouch labelled Membrane Unit)

The control and/or test dot will appear on the test device once the test is performed. The test device is prepared with control (IgM/IgG capture) and test (gp41 and gp36 antigen) reaction dots. It is individually packaged and is to be used only once to complete a single INSTI test.

Sample Diluent (Bottle 1, red cap)

A solution designed to dilute the blood sample and break down red blood cells. It contains 1.5 mL of colorless Tris-Glycine buffered solution containing cell lysis reagents.

Color Developer (Bottle 2, blue cap)

A blue solution that detects human antibodies. It contains 1.5 mL of a blue-coloured Borate buffered proprietary indicator solution designed to detect IgM/IgG in the control dot and HIV-specific antibodies in the test dot.

Clarifying Solution (Bottle 3, clear cap)

A solution to remove background blue color. It contains 1.5 mL of a colorless Tris-Glycine buffered solution designed to remove background staining from the test device prior to reading the INSTI test results.

All solutions contain 0.1% Sodium Azide as a preservative and are harmful if swallowed. All solutions are for single use only and are stable to date and under storage conditions indicated on labels.