INSTI® HIV-1/HIV-2 Antibody Test

bioLytical follows ISO 13485 and the Medical Device Single Audit Program (MDSAP) Certified Quality Management System. MDSAP is a new program that allows a single regulatory audit to be conducted and satisfies the requirements of multiple regulatory jurisdictions (USA, Canada, Australia, Brazil and Japan).

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.

There is no risk of being infected with HIV from the INSTI Test. There is no HIV present in the product (solution bottles, membrane unit, or any test components). The INSTI Test does not detect HIV itself, but rather the antibodies produced in response to the virus.

The INSTI Test is CLIA-waived for fingerstick blood samples, which means external assessment is not required by Federal (CLIA) regulations when used at a CLIA-waived site. A CLIA Certificate of Waiver is required to perform the test in a waived setting. Furthermore, the test is classified as Moderately Complex for venous whole blood or plasma samples and testing using these sample types may not be performed in CLIA-waived settings.

The schedule and frequency of testing with INSTI Controls should be determined by the end user and their testing facility. However, controls are recommended to be run under the following circumstances: - To verify a new INSTI operator prior to performing testing on patient specimens - When switching to a new lot number of INSTI test kits - Whenever a new shipment of kits is received - When there are deviations in storage or testing location temperature

The CPT code is 86703-92

Yes, capillary pipettes can be purchased in packs of 48, part number: 80-1087

Yes, lancets can be purchased in boxes of 50, part number: 10-1042

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

Every solution vial and membrane unit has its own lot number and expiry date which is printed on its label. The INSTI Test Kit pouch, box and the shipping case has the INSTI Test Kit lot number and expiry date printed on its outer label. Should you encounter any issues with the INSTI Test please remember to record the INSTI Test Kit Lot number as this is the one that combines all components of the test kit. The expiry date format for all INSTI Test products is yyyy-mm-dd.

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

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.

Viruses and bacteria have proteins, lipids and/or sugar molecules on their surface. These molecules can be recognized by our bodies to produce an immune response and are referred to as antigens. The immuny system protects the body from possibly harmful substances by recognizing and responding to antigens. The purpose of an immune response is to recognize and destroy, or try to destroy, substances that include foreign antigens. Antibodies bind to specific antigens on a virus or bacteria and mark them for destruction by other cell types of the immune system and are a major player in our immune responses.

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.

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.