Viruses and bacteria are made up of many different molecules including proteins, fats (lipids) and sugars. A small number of proteins, lipids and/or sugars on these viruses or bacteria are called antigens. When antigens are present in our body, we generate an immune response by producing antibodies. The purpose of an immune response is to recognize and destroy foreign invaders in the body including viruses and bacteria. Antibodies bind to specific antigens on a virus or bacteria and mark it for destruction by the body and are the main player in our immune response.

Everything that is required to run the test is included in the INSTI HIV Self Test Kit. The kit contains an INSTI Test device, Solution Bottles #1 (Sample Diluent), #2 (Colour Developer) and #3 (Clarifying Solution), 1 lancet, an adhesive bandage and instructions for use. Some formats will also include an alcohol wipe. Unlike other self-tests, there is no additional timing device required to complete the test.

The INSTI HIV Self 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.

Extensive research studies have shown that the INSTI HIV Self Test is extremely accurate when performed correctly. The accuracy of medical tests are typically described in terms of sensitivity and specificity. Sensitivity means that all truly positive individuals test positive. Specificity means that all all truly negative persons test negative. The INSTI HIV Self Test has a sensitivity of 99.8%, which means a positive result will be correct 998 out of every 1000 tests. This means that you could expect a false negative result 2 times out of 1000 tests (Rate of 0.2% - 2 false negatives in 1000) The INSTI HIV Self Test has a specificity of 99.5%, which means that a negative result will be correct 995 times out of 1000 tests. This means that you could expect a false positive result 5 times out of 1000 tests (Rate of 0.5% - 1 false positive in 200). The INSTI HIV Self Test is a screening test and is used to test individuals who may have been exposed to HIV. The INSTI HIV Self Test looks for antibodies which are produced in response to the HIV infection. The self test is not a final confirmation of HIV infection, therefore if a positive result is given, it must be followed up on with a doctor for a conclusive laboratory test. All positive results generated from a screening test, require follow up with a doctor for final confirmation.

Length: 2mm and Width: 1.5mm are the correct dimensions. (Self test lancet is different to POC lancet)

Please take a photograph of the damaged pouch/box and email it along with the lot number and proof of purchase (order acknowledgement or till receipt) to customercare@bioLytical.com., technical Support will advise on wether the INSTI Test can still be used, or may arrange for a replacement test to be sent free of charge depending on the severity of the damage.

The area at the top of the membrane of the test device is called the Control Dot. This is a built-in control feature and presents as a blue colour when enough blood sample has been added and the test has been run correctly. If the control dot is the only visible dot this means that the test result is negative and the tester does not have HIV. If two dots are visible the test result is positive. Although the results of the INSTI HIV Self Test are very accurate, a positive result MUST be followed up with a doctor for confirmation as soon as possible so that treatment can be started if necessary. If the control dot does not appear, the test is invalid and has not worked. In this case, the test should be discarded and a new INSTI HIV Self Test should be performed.

Wash your hands with soap and plenty of water. If your skin becomes irritated then it is best to follow up with your doctor. You may need to purchase a new INSTI Self Test kit and start the testing process again if the solutions have been lost.

No. The INSTI HIV Self Test is intended for self testing only. You cannot test others using our device. If you would like a have a friend or relative tested, discuss testing options with them and have them purchase an INSTI HIV Self Test.

After exposure to the HIV infection, it can take 3 to 12 weeks (21-84 days) for an HIV-positive person's body to make enough antibodies for a screening test to detect the HIV infection. This is called the window period. You may test positive with the INSTI HIV Self Test in as little as 21-22 days after infection, however it can take as long as 3 months to produce 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 the infection. If you think you have been exposed to HIV and you get a negative test result during the window period, you should re-test 3 months after your possible exposure to HIV.

We'd like to hear more about your experience. Please contact our dedicated customer care team at customercare@bioLytical.com. We'd be grateful if you could please provide the lot number which is located on the outer packaging of your test, and the details of testing such as when and where you took the test. Our technical support team will respond to your inquiry within 24 hours. Take another look at the Instructions for Use, it explains that invalid results can be caused by not collecting enough blood or not following each step correctly when running the test. The INSTI HIV Self Test Training video provides a helpful guide, with step by step instructions of how to perform the test: https://youtu.be/wiEUV_biXQc. After an invalid result, run the test again or contact your doctor who can arrange for HIV testing for you. The following link www.INSTI.com/support contains a list of countries where the test is sold and the healthcare resources available.

Wash your hands thoroughly with soap and water. Cover with a bandaid if needed.

No. The INSTI Self Test is intended for self testing only. The device was not approved for use in children and we do not have any performance data to support use with this age group.

There is no risk of being infected with HIV from the INSTI HIV Self Test since the test uses HIV antigens to detect antibodies produced in response to the infection. HIV antigens are not infectious since they are only virus particles, not the fully intact virion. There is no HIV present in any component of the INSTI HIV Self Test (solutions, test device or accessories).

Flush eyes with water as a precaution for 10-15 minutes. Remove and dispose contact lenses then continue to rinse the eyes with water. If your eyes become irritated then it is best to follow up with your doctor.

The result is valid as long as both test dot and control dot areas on the membrane are clearly visible and not obstructed by the clot once the test is completed.

If you observed a positive result with the INSTI HIV Self Test, go to your doctor or nearest testing facility to receive confirmatory testing. Remember that any HIV self test is a screening test only and is not a conclusive diagnosis. Confirmatory testing must be coordinated with your doctor.

Relax and have a drink of water Wash hands vigorously with soap and warm water - ensure that hands are dry when finished Stand up and let hands naturally fall below waist level and pulse the finger to get blood to the tip Try clapping, rubbing and squeezing hands and fingers Tuck hands in warmer area of the body e.g. pockets or under armpits Use a heat pad or warming device Place hands around a cup or mug of warm water or beverage Fill a rubber/latex glove with warm water and place hands around it or wet a towel with warm water, squeeze out water and wrap around hand (not more than 42-C (107.6-F) for 3-5 minutes. Clinical & Laboratory Standards Institute guideline)

Continue to make efforts to stay negative by reducing your risks of exposure to HIV, such as practicing safe sex (use of condoms) and using other prevention methods such as PrEP. If you believe that you have been exposed in the past 3 months, repeat testing after 3 months. It is recommended to test every 3-12 months if you are at high risk for acquiring HIV. Anyone participating in high risk activities (E.g. sharing needles for injecting drugs, having sex with HIV positive individuals without the use of a condom) should have HIV testing carried out every 3 months. This frequency of testing would ensure that HIV is identified as quickly as possible. Early diagnosis is important as studies have shown there is an advantage to starting HIV treatment as soon as possible.

Europe*: Place all of the items back into the test device pouch or INSTI box including the safety lancet and tissues used to clean spills. Discreetly throw the box away with your household waste. The item is not suitable for recycling. *Countries may have their own disposal regulations. Please follow your country's regulations to dispose of the product. IF you are unsure, please consult with your local authorities. At the time of creating this document, we were only aware of France's specific disposal regulations. See below. France - Place all of the items back into the box (except the safety lancet which must be taken to a pharmacy who will dispose on your behalf). Discreetly throw the box away with your household waste. The items are not suitable for recycling.

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.