An HIV test kit is used to determine if you have contracted HIV. HIV is the virus that causes AIDS (acquired immunodeficiency syndrome). Most people with HIV do not have AIDS. Cells and are at risk for life-threatening diseases, including dangerous infections, severe pneumonia, and certain cancers. If HIV is detected early, you can get medications that will help you protect your immune system. HIV medication can prevent you from getting AIDS.

A wide range of point of care tests have been made in many countries, but few of them have undergone rigorous and independent assessments. Research on HIV screening tests is only occasionally published in medical journals. Lab professionals may have insight into which tests work best. Extensive research studies have shown that the INSTI HIV-1/HIV-2 Antibody Test is extremely accurate when performed correctly. The accuracy of medical tests is typically described in terms of sensitivity and specificity. Sensitivity means that all HIV-positive individuals test positive. Specificity means that all HIV-negative persons test negative. In US clinical studies, our fast HIV test shows to have a sensitivity of over 99.8% and a specificity of over 99.5%.

After exposure to HIV, it can take from 3 to 12 weeks (21-84 days) for an infected person’s body to make enough antibodies for a screening test to detect them. This is called the window period. IgM antibodies are the first antibodies to be detected by INSTI and are typically present in the bloodstream approximately 3 weeks after infection. An individual may test positive with the INSTI Test in as little as 21-22 days after infection, however depending on the person it can take as long as 3 months for them to produce sufficient antibodies (IgG or IgM) to generate a positive result. Approximately 97% of people will develop detectable antibodies during this window period. A negative result may not be accurate until 3 months after a possible exposure. If someone has been exposed to HIV and obtains a negative test result during the window period, they should re-test 3 months after possible exposure to HIV.

The INSTI HIV-1/HIV-2 Antibody Test is a one-time use, rapid, visually read, flow-through immunoassay which detects antibodies to Human Immunodeficiency Virus (HIV) Type 1 and Type 2 using a drop of human fingerstick blood. Other sample types which can be tested are venous whole blood, plasma and serum. (Note - serum is not approved for the USA). INSTI is not approved as a detection method for blood donor screening.

The INSTI HIV-1/HIV-2 Antibody Test kit contains an INSTI Membrane Unit, Solution Bottles #1 (Sample Diluent), #2 (Colour Developer), #3 (Clarifying Solution), 1 single-use lancet, and 1 capillary pipette. Unlike other HIV tests, there is no additional timing device required to complete the test as results are available immediately. Instructions For Use and alcohol wipe are also included. In the United States, a Subject Information Brochure is also included to provide further details on HIV/AIDS. A Quick Reference Guide is provided for sites with a CLIA certificate of Waiver.

The membrane unit is individually packaged in a small pouch. The membrane unit contains two layers of material, the top layer is a filtration membrane and the bottom layer is an absorbent pad. The blood sample and all test solutions #1 (Sample Diluent), #2 (Colour Developer) and #3 (Clarifying Solution), are added into the sample well of the membrane unit as part of the testing process. The membrane unit filters, absorbs, and retains all the liquids to prevent leakage and exposure to potentially infectious materials.

There are 5 different classes of antibodies (IgM, IgA, IgD, IgG and IgE) in the blood, each one has a different structure and function. IgG is the most abundant and diverse antibody and accounts for approximately 80% of the antibodies circulating in the bloodstream. It is the main antibody involved in both primary and secondary immune responses and protects against bacteria, viruses, and toxins circulating in blood and lymph. IgM also circulates in blood and is the first antibody released during the primary immune response. Presence of IgM indicates an established or early infection by a pathogen. IgM is large and has multiple antigen binding sites which means it is able to quickly attach to antigens and activate further immune response. It is for these reasons that the INSTI Test was designed to capture IgG & IgM.

The INSTI HIV-1/HIV-2 Antibody Test is considered a 3rd generation screening test since it is designed to detect antibodies only that are generated in response to HIV infection. 4th generation tests detect both antibodies and p24 antigen, as p24 antigen is present earlier in infection but only for a limited time.

The procedure takes 1 minute, once each solution (#1, #2 and #3) has been added to the membrane unit, the result is visible.

Training can be arranged with your local sales representative or distributor. It can be done virtually or using our online training courses. Contact customercare@bioLytical.com who can arrange this for you. You can also view the step by step process of running the test on the following YouTube video https://youtu.be/7ShDhnwISBg

The INSTI Test kits have a shelf life of 15 months when manufactured. The expiry date is printed on the Test Kit pouch and on the outer box in the format yyyy-mm-dd. The expiry date is determined by the shortest dated component in the kit. E.g. Membrane Unit/Colour Developer.

The storage temperature for the INSTI Test is 2 - 30°C (35.6 - 86°F). TB-010 can be sent to customer as a reference.